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Glyburide × noninferiority to insulin for the perinatal composite: evidence checklist

Select a review item to see its details.
Required evidence, verification status and materials actually read
ItemAVerification statusBReading scopeCReview itemDCurrent findingsEWhy unverifiedFRequired materials and conditionsGFurther research
1 Partly verified Full text not readStored summary read N01 · Noninferiority comparison and production from preserved materialWhich existing noninferiority question is being turned into a table?Required
The selected question is “Noninferiority to insulin for the perinatal composite”; subclaim C and “the CI upper bound of +10.5 percentage points exceeded the +7-percentage-point margin” are preserved. The parent is C54.
S01 S02 S03
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Subclaim score/status/axis keys are absent and are not filled from parent values. The sibling D question about harm superiority is separate. The original content review remains incomplete.
Separation of the selected question, subclaim grade, and parent context
Update while maintaining the selected question and verdict record separately. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
2 Partly verified Full text not readStored summary read N02 · Noninferiority comparison and production from preserved materialWhat were the actual INDAO population and recruitment conditions?Required
The original scope is women with gestational diabetes requiring medication even after 10 days of dietary treatment, at 13 French university hospitals.
S01
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Details of age, gestational week, diagnostic/glucose criteria, baseline risk, and inclusion/exclusion are unverified in this summary. The original content review remains incomplete.
Gestational diabetes, medication requirement, inclusion/exclusion, and gestational timing
Distinguish the actual population from other pregnancy/diabetes populations. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
3 Partly verified Full text not readStored summary read N03 · Noninferiority comparison and production from preserved materialWhat were the actual intervention and comparator?Required
The manuscript records a comparison of oral sulfonylurea glyburide with injected insulin. This wording describes historical study conditions; it is not medication-selection or administration guidance.
S01
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Exact doses, escalation, actual exposure duration, insulin type/regimen, and arm-specific changes are unverified. The original content review remains incomplete.
Glyburide, subcutaneous insulin, study exposure, and comparison direction
Link nominal assignment and actual exposure separately. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
4 Partly verified Full text not readStored summary read N04 · Noninferiority comparison and production from preserved materialHow much is known about design, allocation, and blinding?Required
INDAO is a multicenter open-label randomized noninferiority trial. It assigned 914 participants: 460 to glyburide and 454 to insulin.
S01
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Allocation sequence, concealment, arm-specific baseline balance, and assessor/analyst blinding are unverified. The open-label design is not turned into a new failure judgment. The original content review remains incomplete.
Open-label randomized noninferiority design, concealment, and baseline balance
Separate the design label from operational details actually verified. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
5 Partly verified Full text not readStored summary read N05 · Noninferiority comparison and production from preserved materialHow was the perinatal composite defined?Required
The prespecified primary endpoint was a perinatal composite of at least one of macrosomia, neonatal hypoglycemia, or hyperbilirubinemia.
S01
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Component criteria, collection methods, neonatal denominators, handling of overlapping events, and exact period are unverified. The original content review remains incomplete.
Composite-event definition, component criteria, and overlap counting
Keep the composite and its individual components as different outcomes. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
6 Partly verified Full text not readStored summary read N06 · Noninferiority comparison and production from preserved materialHow much is known about perinatal timing and the observation period?Required
The manuscript describes a perinatal composite of actual birth-related events.
S01
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Treatment start/end, assessment windows around birth, and follow-up after discharge are unverified. The result is not extended to long-term offspring outcomes. The original content review remains incomplete.
Medication exposure, assessment around birth, and follow-up scope
Record exposure timing and event-assessment timing separately. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
7 Partly verified Full text not readStored summary read N07 · Noninferiority comparison and production from preserved materialAre the prespecified primary PP analysis and randomized denominator distinguished?Required
Original values are preserved: 914 randomized (460/454) and 809 in the prespecified primary PP analysis (367/442).
S01
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. PP definition, arm-specific reasons for exclusion/switching, and neonatal analysis units are unverified. No new exclusion counts or rates are calculated. The original content review remains incomplete.
Randomization, PP, arm-specific exclusions/switching, and analysis denominators
Distinguish assignment, actual exposure, maternal/neonatal observations, and analysis denominators. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
8 Partly verified Full text not readStored summary read N08 · Noninferiority comparison and production from preserved materialWhich population do the observed rates and absolute difference describe?Required
The original INDAO perinatal-composite result is 27.6% with glyburide versus 23.4% with insulin, an absolute difference of +4.2 percentage points. It is linked to the prespecified primary PP analysis context.
S01
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Unrounded rates, event counts, and exact maternal/neonatal denominator correspondence are unverified. No event counts or new differences are calculated from rates. The original content review remains incomplete.
Arm correspondence, events/people, denominators, and original estimator
Attribute original rates, differences, and denominators individually. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
9 Partly verified Full text not readStored summary read N09 · Noninferiority comparison and production from preserved materialWhat are the one-sided interval and noninferiority P value?Required
The original one-sided 97.5% CI upper bound of +10.5 percentage points and noninferiority P=0.19 are preserved.
S01
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. The lower bound, full interval, calculation model, and superiority-test CI/P are unverified in this summary. No new two-sided CI or superiority P is calculated from the one-sided upper bound. The original content review remains incomplete.
One-sided confidence level, upper bound, testing hypothesis, and original P value
Distinguish noninferiority and superiority test quantities. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
10 Partly verified Full text not readStored summary read N10 · Noninferiority comparison and production from preserved materialWhat criterion does the prespecified +7-percentage-point margin represent?Required
The manuscript declares a prespecified +7-percentage-point margin and records that the one-sided upper bound of +10.5 percentage points exceeded it.
S01
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Clinical/statistical rationale for the margin, the original prespecified plan, and sample-size assumptions remain unread. The original content review remains incomplete.
Rationale, direction, and timing of the noninferiority margin
Distinguish the original margin from criteria in newly supplied material. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
11 Partly verified Full text not readStored summary read N11 · Noninferiority comparison and production from preserved materialHow is failure to demonstrate noninferiority preserved as a conclusion?Required
The manuscript states that being within the acceptable margin was not demonstrated, and explicitly distinguishes this from demonstrating significantly worse results.
S01
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. No new conclusion of an exactly zero effect, equivalence, or significant harm is created. A separate superiority plan/analysis is unverified. The original content review remains incomplete.
Logical separation of demonstrating an acceptable margin from superiority in harm
Separate design-specific questions and the scope of the original conclusion. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
12 Partly verified Full text not readStored summary read N12 · Noninferiority comparison and production from preserved materialWhich material addresses consistency in other analysis populations?Required
The manuscript says other analysis populations were used to assess consistency.
S01
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Their names, denominators, original effects/CIs, missing-data handling, and values relative to PP are unverified. They are not arbitrarily filled as quantitative ITT confirmation. The original content review remains incomplete.
ITT/other populations, denominators, quantitative results, and effect of interest
Link the primary PP analysis and actual supplementary analyses separately. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
13 Unverified Full text not readStored summary read N13 · Noninferiority comparison and production from preserved materialAre cointerventions, rescue insulin, and adherence/switching known?Required
The stored summary describes a population requiring medication after dietary treatment and a glyburide/insulin comparison.
S01
Currently required information in the stored summary is unverified. Arm-specific rescue treatment, switching, dose/adherence, concomitant care, and analytical handling are unverified. Actual switching is not invented. The original content review remains incomplete.
Common dietary treatment, arm-specific treatment changes, rescue treatment, and handling of departures
Link assignment and treatment departures to the effect being estimated. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
14 Unverified Full text not readStored summary read N14 · Noninferiority comparison and production from preserved materialWere composite events measured under comparable conditions?Required
The original description of a perinatal composite in an open-label trial is preserved.
S01
Currently required information in the stored summary is unverified. Measurement criteria/schedules for macrosomia, hypoglycemia, and hyperbilirubinemia, missed tests, and decision-maker blinding are unverified. The original content review remains incomplete.
Component measurement, testing, blinding, and differences in detection
Distinguish objective event names from actual measurement conditions. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
15 Partly verified Full text not readStored summary read N15 · Noninferiority comparison and production from preserved materialWhat was verified about registration, protocol, and SAP?Required
The original registration identifier is NCT01731431. Preserved descriptions of prespecified PP, the primary composite, and +7 percentage points are linked.
S01
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Registration, protocol, SAP, and change history remain unread; access was not attempted. The number is not treated as review of agreement with the plan. The original content review remains incomplete.
Registration identity, prespecified primary analysis, margin, and change history
If material is supplied, record prespecification, changes, and reporting separately. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
16 Partly verified Full text not readStored summary read N16 · Noninferiority comparison and production from preserved materialWhat are INDAO’s public funding and sponsor?Required
The French Ministry of Health Programme Hospitalier de Recherche Clinique public grant and Assistance Publique–Hôpitaux de Paris public sponsor support are preserved as originally recorded.
S01
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Contracts, itemized amounts, and actual design/analysis/writing roles are unverified. Public funding is not extended to confirmation of all independence criteria. The original content review remains incomplete.
PHRC public grant, AP-HP sponsor, and roles
Link funding provision and research roles separately. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
17 Partly verified Full text not readStored summary read N17 · Noninferiority comparison and production from preserved materialAre unreported commercial support and detailed COI distinguished?Required
The manuscript records that commercial pharmaceutical funding or free study medication was not reported.
S01
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Actual absence was not newly established. Employee authors, patents, outsourced analysis, individual COI, and writing/publication support details are unverified. The original content review remains incomplete.
Commercial funding, study medication, author employment/patents, and analysis/writing support
Distinguish the reporting scope from separately unverified relationships. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
18 Partly verified Full text not readStored summary read N18 · Noninferiority comparison and production from preserved materialDid the earlier Langer trial have the same noninferiority framework?Required
Langer 2000 was a 404-participant glyburide-versus-insulin RCT. The manuscript records primary glycemic control and secondary individual perinatal complications, without a prespecified noninferiority test.
S03
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Detailed population, denominators, duration, glycemic-control values, and original plan remain unread. It is not counted as replication of the same perinatal-composite noninferiority question. The original content review remains incomplete.
Earlier trial’s primary endpoint, design, population/comparison, and prespecified margin
Maintain different questions for the primary endpoint and secondary outcomes. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
19 Partly verified Full text not readStored summary read N19 · Noninferiority comparison and production from preserved materialHow are Langer’s individual complications and alternative conclusion preserved?Required
LGA 12% versus 13%, neonatal hypoglycemia 9% versus 6%, no significant difference in individual complications, and the “clinically effective alternative” conclusion are preserved as originally recorded.
S03
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Original CI/P, denominators, and definitions are unverified. Nonsignificance is not changed into being within an acceptable margin, equivalence, or reversal of INDAO. The original content review remains incomplete.
LGA/hypoglycemia results, nonsignificance, and scope of the original conclusion
Record the earlier opposing conclusion together with actual design differences. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
20 Unverified Full text not readStored summary read N20 · Noninferiority comparison and production from preserved materialDo Langer’s registration and funding entries establish actual identities?Required
The nct entry “not applicable” and funding entry “reported in the original paper” are preserved as originally recorded. The latter is not a verified provider name.
S03
Currently required information in the stored summary is unverified. Existence of registration/plans and actual funding, product support, and author COI are unverified. “Not applicable” is not used as current certification of absence. The original content review remains incomplete.
Original registration wording and actual support/COI information
Separate wording from actual identifiers and disclosure information. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
21 Partly verified Full text not readStored summary read N21 · Noninferiority comparison and production from preserved materialDo Helal’s overall review and RCT subgroup have the same denominator?Required
The original review records 24 studies with a total of 24,517 participants and an 11-RCT subgroup analysis.
S02
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. The RCT subgroup participant count, endpoint-specific denominators, and included-trial/overlap tables are unverified. The overall 24,517 is not repurposed as the 11-RCT denominator or newly summed with INDAO/Langer. The original content review remains incomplete.
Study designs, overall/RCT subsets, and endpoint-specific denominators
Link overall synthesis and RCT subgroup analyses separately. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
22 Partly verified Full text not readStored summary read N22 · Harm-information gaps and supplementation of the noninferiority tableAre RCT-subgroup and overall pooled results kept separate?Supplementary
S02’s evidence list distinguishes increased maternal hypoglycemia and LGA in the RCT subgroup from overall pooled neonatal hypoglycemia OR 1.42 (95% CI 1.03–1.95).
S02
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. The Korean/English manuscript’s safety explanation describes increased neonatal hypoglycemia and LGA in the RCT subgroup, differing in specific attribution from the evidence list. Both wordings are preserved while the original paper remains unread; no automatic resolution or reassessment to a new analysis level is made. The original content review remains incomplete.
Attribution of maternal/neonatal hypoglycemia, LGA, and analysis levels
If the original paper explains the wording difference, distinguish the source and correction event. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
23 Unverified Full text not readStored summary read N23 · Noninferiority comparison and production from preserved materialAre review support, registration, and protocol known?Required
The funding entry “systematic review; included-trial funding mixed” and nct entry “not applicable” are preserved as originally recorded.
S02
Currently required information in the stored summary is unverified. The review’s own funding/COI, registration/plans, and each included trial’s disclosures are unverified. Mixed support is not changed into identical independence or actual absence. The original content review remains incomplete.
Funding/COI and plans for the review itself and its included trials
Record roles/support for the review and included trials separately. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
24 Partly verified Full text not readStored summary read N24 · Harm-information gaps and supplementation of the noninferiority tableCan component risks substitute for composite noninferiority?Supplementary
INDAO’s primary endpoint is a composite of at least one of three events. Langer’s LGA/neonatal hypoglycemia and Helal’s individual safety results are separate endpoints.
S01 S02 S03
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. INDAO component-level quantitative results, multiplicity, and denominators are unverified. Macrosomia and LGA definitions are not filled as identical, and individual results are not transferred to the composite. The original content review remains incomplete.
Individual values, definitions, and denominators for macrosomia, hypoglycemia, and hyperbilirubinemia
Separate the composite, components, and events in other material. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
25 Partly verified Full text not readStored summary read N25 · Harm-information gaps and supplementation of the noninferiority tableWhat is the scope of maternal hypoglycemia and other harms?Supplementary
The manuscript records more frequent maternal hypoglycemia in the glyburide arm. This is not repurposed as significant superiority in harm for the entire perinatal composite.
S01 S02
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Arm-specific counts, denominators, CI/P, definitions, severity, other adverse events, and discontinuation information are unverified. No new incidence rates, causality conclusions, or safety grades are created. The original content review remains incomplete.
Maternal events, arm-specific values, collection, period, and separation from neonatal outcomes
Maintain maternal and neonatal event units and comparisons separately. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
26 Partly verified Full text not readStored summary read N26 · Noninferiority comparison and production from preserved materialHow are the same reports/cohorts distinguished from independent replication?Required
INDAO/NCT01731431, Langer 2000, and the Helal 2020 review are linked as separate report items. The two sibling sheets share the same stored summary and reports.
S01 S02 S03
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Review inclusion, subsequent reports, and trial-identity overlaps were not checked. Original R1/E~ are not used as new replication/independence certification; unique clinical totals remain unrecorded. The original content review remains incomplete.
Relationships among INDAO, Langer, Helal, included trials, and subsequent reports
Distinguish report counts from unique clinical-trial and participant counts. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
27 Partly verified Full text not readStored summary read N27 · Noninferiority comparison and production from preserved materialIs the result extended to medications, periods, or clinical questions outside its scope?Required
The manuscript records that sulfonylurea placental transfer varies by drug and is not generalized to the entire class. Oral convenience is not noninferiority evidence.
S01 S02 S03
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Direct evidence for other drugs, conditions, pregnancy periods, and long-term offspring outcomes is unverified. No medication-selection, substitution, or administration instructions for pregnant women are created. The original content review remains incomplete.
Other medications/classes, timing, long-term outcomes, convenience, and clinical evidence
Separate the original noninferiority question from extension questions. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
28 Partly verified Full text not readStored summary read N28 · Noninferiority comparison and production from preserved materialWhat historical context do parent score, axes, bilingual manuscript, dates, and corrections provide?Required
C54, safety Caution, unrecorded precision in the original axes, false values, empty override reasons, Korean/English manuscripts, 2026-08-26, empty correction/deliberation values, and historical cross-checking are preserved in the full stored summary.
S01 S02 S03
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. This is not a current search, correction/retraction check, or completed content review. Parent scores or axes are not filled into subclaims C/D. The original content review remains incomplete.
Original C54 verdict, language-specific wording, unrecorded/false/empty values, and correction history
Separate original records from production and correction events. This is a proposal; no new investigation, calculation, or trial was performed.
29 Partly verified Full text not readStored summary read N29 · Noninferiority comparison and production from preserved materialAre actual summary reading and unread external material separated?Required
The full stored summary’s three evidence entries, three citations, Korean/English manuscripts, and selected item were read for production. Summaries are marked “summary read”; external papers, registration/plans, and disclosures are marked “unread”, with original source links connected.
S01 S02 S03
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. External abstracts/full texts, registration, protocols, SAPs, and disclosures were not accessed, clicked, or link-tested. Not attempted is not marked inaccessible. The original content review remains incomplete.
Existence, acquisition, actual reading, and original URLs for each material
Update material types and access/reading levels separately. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
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29 itemsWhat the statuses mean

Assessment scope

Stored-material review date
Not recorded
Original evidence cut-off
2026-08-26
Scope actually checked
Existing review summaries and stored records of methodological application. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean
This is the date the stored materials were checked, not the date of a new search of the clinical literature.
Population
Gestational diabetes requiring medication even after 10 days of dietary treatment; 13 French university hospitals
Ingredient, formulation and route
Original study: oral glyburide; exact dose/duration/actual exposure unverified
Dose
Not recorded
Comparator
Injected insulin; exact regimen/actual exposure unverified
Measured outcome
Noninferiority for a perinatal composite of at least one of macrosomia, neonatal hypoglycemia, or hyperbilirubinemia
Duration
Perinatal; exact exposure/event-assessment windows unverified
Questions outside this scope
Changing failure to demonstrate noninferiority into significant superiority in harm, equivalence, an exactly zero effect, or confirmation of all safety outcomes; Repurposing the one-sided 97.5% upper bound of +10.5 percentage points/noninferiority P=.19 as a full two-sided CI/harm-superiority P, or calculating new values; Replacing 914 randomized (460/454), PP 809 (367/442), and maternal/neonatal/event denominators as the same unit, or calculating new exclusion/event/risk counts; Treating the composite, macrosomia, LGA, neonatal hypoglycemia, hyperbilirubinemia, and maternal hypoglycemia as the same outcome; Substituting Helal’s overall 24,517 participants, 11 RCTs, and endpoint-specific subset denominators, or repurposing the overall neonatal OR as an RCT-only/INDAO/composite value; Automatically resolving or reassessing the review-attribution difference between the stored summary’s evidence list and safety explanation while the original paper remains unread; Changing Langer’s 404 participants, primary glycemic control/secondary individual perinatal outcomes, or nonsignificance into passing composite NI at +7 percentage points, reversing INDAO, or zero harm; Summing the review, original trial, subsequent reports, sibling tables, people/arms/events/timepoints as new independent trials, participants, or replications; Changing funding reported in the original paper/systematic review, nct not applicable, or unreported commercial support into an actual provider, absence, registration identifier, or independence certification; Inheriting parent C54, original axes, or historical cross-checking as selected C/D scores/axes, current content review, or external reading; New calculations, invented values, new effects/CIs, reassessment, independence certification, or instructions to implement medication selection/substitution/administration/treatment/monitoring for pregnant women

Evidence and sources

The links below lead to the sources. A link alone does not mean the original source was read or its latest publication status verified.

S01 · Sénat MV et al. 2018 INDAO

PubMed

Material type
Multicenter open-label randomized noninferiority trial
Materials actually read
Summary read; external material unread
Findings recorded in the stored summary
27.6% versus 23.4%, difference +4.2 percentage points, one-sided 97.5% CI upper bound +10.5 percentage points; noninferiority P=0.19. The original conclusion that being within the prespecified +7-percentage-point margin was not demonstrated is preserved. Rates, difference, one-sided upper bound, and PP context are distinct; no new event counts, RR/OR, two-sided CI, or superiority P are calculated.
Record level
Outcome wording in the stored summary
Study overlap and independent replication
S01 INDAO/NCT01731431 is an open-label randomized noninferiority trial at 13 French university hospitals in 914 women with medication-requiring gestational diabetes (glyburide 460/insulin 454). Prespecified PP 809 (367/442), perinatal-composite rates 27.6/23.4%, original difference +4.2 percentage points, one-sided 97.5% CI upper bound +10.5 percentage points, prespecified margin +7 percentage points, and noninferiority P=.19 are separated. The two sibling tables share the same trial/reports/participants/composition; no new independent trials/totals are created. Report/material slots are not unique clinical-trial, participant, or independent-replication totals; unique totals remain null. The same summary, bibliography, trial, events, timepoints, and sibling sheets are not summed as new independent replications. S02 Helal 2020 is the original synthesis report of 24 studies, 24,517 participants overall, and an 11-RCT subgroup. The evidence list separates RCT maternal hypoglycemia/LGA increases from overall pooled neonatal hypoglycemia OR 1.42 (CI 1.03–1.95), whereas the safety explanation describes RCT neonatal hypoglycemia/LGA. Each record and attribution difference are preserved without resolution while the original paper remains unread. Included-trial overlaps with INDAO/Langer and endpoint-specific denominators are unverified. Report/material slots are not unique clinical-trial, participant, or independent-replication totals; unique totals remain null. The same summary, bibliography, trial, events, timepoints, and sibling sheets are not summed as new independent replications. S03 Langer 2000 reports a 404-participant glyburide-versus-insulin RCT, primary glycemic control, and secondary individual perinatal outcomes. It was not a prespecified noninferiority test; LGA 12/13%, neonatal hypoglycemia 9/6%, no significant individual differences, and the opposing “clinically effective alternative” conclusion are preserved. It is not turned into replication/reversal of INDAO composite NI, zero harm, or equivalence. Funding “reported in the original paper”/nct “not applicable” do not establish an actual provider, registration identifier, or absence certification. Report/material slots are not unique clinical-trial, participant, or independent-replication totals; unique totals remain null. The same summary, bibliography, trial, events, timepoints, and sibling sheets are not summed as new independent replications.
Public availability, access and reading status by material
MaterialPublic availabilityAccess statusActually readNotes
Stored summaryStored fileStored summarySummary readOnly stored-summary and bibliographic content was used for production. External material verification/review is not complete.
External paperPublic availability unverified; only bibliography links preservedUnread; access not attemptedNot readNo external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Registration materialPublic availability unverified; only bibliography links preservedUnread; access not attemptedNot readNo external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
ProtocolPublic availability unverified; only bibliography links preservedUnread; access not attemptedNot readNo external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Statistical analysis planPublic availability unverified; only bibliography links preservedUnread; access not attemptedNot readNo external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Funding, product-support and COI materialPublic availability unverified; only bibliography links preservedUnread; access not attemptedNot readNo external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.

S02 · Helal KF et al. 2020 systematic review and meta-analysis

PubMed

Material type
11-RCT subgroup analysis within 24 studies
Materials actually read
Summary read; external material unread
Findings recorded in the stored summary
More maternal hypoglycemia and LGA with glyburide in the RCT subgroup, and overall pooled neonatal hypoglycemia OR 1.42 (95% CI 1.03–1.95). Wording at a different analysis level in the stored summary’s safety explanation is also preserved. The overall OR is not repurposed as RCT-only/INDAO/composite data; no new effects/CIs/totals/reassessment are created.
Record level
Outcome wording in the stored summary
Study overlap and independent replication
S01 INDAO/NCT01731431 is an open-label randomized noninferiority trial at 13 French university hospitals in 914 women with medication-requiring gestational diabetes (glyburide 460/insulin 454). Prespecified PP 809 (367/442), perinatal-composite rates 27.6/23.4%, original difference +4.2 percentage points, one-sided 97.5% CI upper bound +10.5 percentage points, prespecified margin +7 percentage points, and noninferiority P=.19 are separated. The two sibling tables share the same trial/reports/participants/composition; no new independent trials/totals are created. Report/material slots are not unique clinical-trial, participant, or independent-replication totals; unique totals remain null. The same summary, bibliography, trial, events, timepoints, and sibling sheets are not summed as new independent replications. S02 Helal 2020 is the original synthesis report of 24 studies, 24,517 participants overall, and an 11-RCT subgroup. The evidence list separates RCT maternal hypoglycemia/LGA increases from overall pooled neonatal hypoglycemia OR 1.42 (CI 1.03–1.95), whereas the safety explanation describes RCT neonatal hypoglycemia/LGA. Each record and attribution difference are preserved without resolution while the original paper remains unread. Included-trial overlaps with INDAO/Langer and endpoint-specific denominators are unverified. Report/material slots are not unique clinical-trial, participant, or independent-replication totals; unique totals remain null. The same summary, bibliography, trial, events, timepoints, and sibling sheets are not summed as new independent replications. S03 Langer 2000 reports a 404-participant glyburide-versus-insulin RCT, primary glycemic control, and secondary individual perinatal outcomes. It was not a prespecified noninferiority test; LGA 12/13%, neonatal hypoglycemia 9/6%, no significant individual differences, and the opposing “clinically effective alternative” conclusion are preserved. It is not turned into replication/reversal of INDAO composite NI, zero harm, or equivalence. Funding “reported in the original paper”/nct “not applicable” do not establish an actual provider, registration identifier, or absence certification. Report/material slots are not unique clinical-trial, participant, or independent-replication totals; unique totals remain null. The same summary, bibliography, trial, events, timepoints, and sibling sheets are not summed as new independent replications.
Public availability, access and reading status by material
MaterialPublic availabilityAccess statusActually readNotes
Stored summaryStored fileStored summarySummary readOnly stored-summary and bibliographic content was used for production. External material verification/review is not complete.
External paperPublic availability unverified; only bibliography links preservedUnread; access not attemptedNot readNo external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Registration materialPublic availability unverified; only bibliography links preservedUnread; access not attemptedNot readNo external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
ProtocolPublic availability unverified; only bibliography links preservedUnread; access not attemptedNot readNo external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Statistical analysis planPublic availability unverified; only bibliography links preservedUnread; access not attemptedNot readNo external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Funding, product-support and COI materialPublic availability unverified; only bibliography links preservedUnread; access not attemptedNot readNo external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.

S03 · Langer O et al. 2000

PubMed

Material type
Randomized glyburide-versus-insulin trial
Materials actually read
Summary read; external material unread
Findings recorded in the stored summary
LGA 12% versus 13%, neonatal hypoglycemia 9% versus 6%; no significant difference in individual complications; “clinically effective alternative” conclusion. Individual values and the original alternative conclusion are attributed to that earlier trial. Gaps in denominators/original CI/P/plans remain; no new judgment of passing NI, significant harm, or an exactly zero effect is made.
Record level
Outcome wording in the stored summary
Study overlap and independent replication
S01 INDAO/NCT01731431 is an open-label randomized noninferiority trial at 13 French university hospitals in 914 women with medication-requiring gestational diabetes (glyburide 460/insulin 454). Prespecified PP 809 (367/442), perinatal-composite rates 27.6/23.4%, original difference +4.2 percentage points, one-sided 97.5% CI upper bound +10.5 percentage points, prespecified margin +7 percentage points, and noninferiority P=.19 are separated. The two sibling tables share the same trial/reports/participants/composition; no new independent trials/totals are created. Report/material slots are not unique clinical-trial, participant, or independent-replication totals; unique totals remain null. The same summary, bibliography, trial, events, timepoints, and sibling sheets are not summed as new independent replications. S02 Helal 2020 is the original synthesis report of 24 studies, 24,517 participants overall, and an 11-RCT subgroup. The evidence list separates RCT maternal hypoglycemia/LGA increases from overall pooled neonatal hypoglycemia OR 1.42 (CI 1.03–1.95), whereas the safety explanation describes RCT neonatal hypoglycemia/LGA. Each record and attribution difference are preserved without resolution while the original paper remains unread. Included-trial overlaps with INDAO/Langer and endpoint-specific denominators are unverified. Report/material slots are not unique clinical-trial, participant, or independent-replication totals; unique totals remain null. The same summary, bibliography, trial, events, timepoints, and sibling sheets are not summed as new independent replications. S03 Langer 2000 reports a 404-participant glyburide-versus-insulin RCT, primary glycemic control, and secondary individual perinatal outcomes. It was not a prespecified noninferiority test; LGA 12/13%, neonatal hypoglycemia 9/6%, no significant individual differences, and the opposing “clinically effective alternative” conclusion are preserved. It is not turned into replication/reversal of INDAO composite NI, zero harm, or equivalence. Funding “reported in the original paper”/nct “not applicable” do not establish an actual provider, registration identifier, or absence certification. Report/material slots are not unique clinical-trial, participant, or independent-replication totals; unique totals remain null. The same summary, bibliography, trial, events, timepoints, and sibling sheets are not summed as new independent replications.
Public availability, access and reading status by material
MaterialPublic availabilityAccess statusActually readNotes
Stored summaryStored fileStored summarySummary readOnly stored-summary and bibliographic content was used for production. External material verification/review is not complete.
External paperPublic availability unverified; only bibliography links preservedUnread; access not attemptedNot readNo external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Registration materialPublic availability unverified; only bibliography links preservedUnread; access not attemptedNot readNo external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
ProtocolPublic availability unverified; only bibliography links preservedUnread; access not attemptedNot readNo external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Statistical analysis planPublic availability unverified; only bibliography links preservedUnread; access not attemptedNot readNo external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Funding, product-support and COI materialPublic availability unverified; only bibliography links preservedUnread; access not attemptedNot readNo external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.

Report counts versus independent study counts

S01 INDAO/NCT01731431 is an open-label randomized noninferiority trial at 13 French university hospitals in 914 women with medication-requiring gestational diabetes (glyburide 460/insulin 454). Prespecified PP 809 (367/442), perinatal-composite rates 27.6/23.4%, original difference +4.2 percentage points, one-sided 97.5% CI upper bound +10.5 percentage points, prespecified margin +7 percentage points, and noninferiority P=.19 are separated. The two sibling tables share the same trial/reports/participants/composition; no new independent trials/totals are created. Report/material slots are not unique clinical-trial, participant, or independent-replication totals; unique totals remain null. The same summary, bibliography, trial, events, timepoints, and sibling sheets are not summed as new independent replications. S02 Helal 2020 is the original synthesis report of 24 studies, 24,517 participants overall, and an 11-RCT subgroup. The evidence list separates RCT maternal hypoglycemia/LGA increases from overall pooled neonatal hypoglycemia OR 1.42 (CI 1.03–1.95), whereas the safety explanation describes RCT neonatal hypoglycemia/LGA. Each record and attribution difference are preserved without resolution while the original paper remains unread. Included-trial overlaps with INDAO/Langer and endpoint-specific denominators are unverified. Report/material slots are not unique clinical-trial, participant, or independent-replication totals; unique totals remain null. The same summary, bibliography, trial, events, timepoints, and sibling sheets are not summed as new independent replications. S03 Langer 2000 reports a 404-participant glyburide-versus-insulin RCT, primary glycemic control, and secondary individual perinatal outcomes. It was not a prespecified noninferiority test; LGA 12/13%, neonatal hypoglycemia 9/6%, no significant individual differences, and the opposing “clinically effective alternative” conclusion are preserved. It is not turned into replication/reversal of INDAO composite NI, zero harm, or equivalence. Funding “reported in the original paper”/nct “not applicable” do not establish an actual provider, registration identifier, or absence certification. Report/material slots are not unique clinical-trial, participant, or independent-replication totals; unique totals remain null. The same summary, bibliography, trial, events, timepoints, and sibling sheets are not summed as new independent replications.

Review criteria

Version 1.0 · Criteria record date 2026-10-06. These are Chamgap's own application conditions, informed by the referenced methods. They do not constitute official assessment-tool certification or a new efficacy score.

N01 · Which existing noninferiority question is being turned into a table?
Required materials and conditions
Separation of the selected question, subclaim grade, and parent context
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Separation of the selected question, subclaim grade, and parent context. Stored wording is linked here; the original content review remains incomplete.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Separation of the selected question, subclaim grade, and parent context.
Referenced methods
M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design
N02 · What were the actual INDAO population and recruitment conditions?
Required materials and conditions
Gestational diabetes, medication requirement, inclusion/exclusion, and gestational timing
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Gestational diabetes, medication requirement, inclusion/exclusion, and gestational timing. Stored wording is linked here; the original content review remains incomplete.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Gestational diabetes, medication requirement, inclusion/exclusion, and gestational timing.
Referenced methods
M03 §3.2.1; detailed population conditions are Chamgap's own design
N03 · What were the actual intervention and comparator?
Required materials and conditions
Glyburide, subcutaneous insulin, study exposure, and comparison direction
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Glyburide, subcutaneous insulin, study exposure, and comparison direction. Stored wording is linked here; the original content review remains incomplete.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Glyburide, subcutaneous insulin, study exposure, and comparison direction.
Referenced methods
M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application
N04 · How much is known about design, allocation, and blinding?
Required materials and conditions
Open-label randomized noninferiority design, concealment, and baseline balance
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Open-label randomized noninferiority design, concealment, and baseline balance. Stored wording is linked here; the original content review remains incomplete.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Open-label randomized noninferiority design, concealment, and baseline balance.
Referenced methods
M08 §8.1–8.2.3; internal application; M08 Table 8.2.a, M03 §3.2.4; internal application
N05 · How was the perinatal composite defined?
Required materials and conditions
Composite-event definition, component criteria, and overlap counting
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Composite-event definition, component criteria, and overlap counting. Stored wording is linked here; the original content review remains incomplete.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Composite-event definition, component criteria, and overlap counting.
Referenced methods
M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are our own design
N06 · How much is known about perinatal timing and the observation period?
Required materials and conditions
Medication exposure, assessment around birth, and follow-up scope
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Medication exposure, assessment around birth, and follow-up scope. Stored wording is linked here; the original content review remains incomplete.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Medication exposure, assessment around birth, and follow-up scope.
Referenced methods
M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed
N07 · Are the prespecified primary PP analysis and randomized denominator distinguished?
Required materials and conditions
Randomization, PP, arm-specific exclusions/switching, and analysis denominators
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Randomization, PP, arm-specific exclusions/switching, and analysis denominators. Stored wording is linked here; the original content review remains incomplete.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Randomization, PP, arm-specific exclusions/switching, and analysis denominators.
Referenced methods
M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application
N08 · Which population do the observed rates and absolute difference describe?
Required materials and conditions
Arm correspondence, events/people, denominators, and original estimator
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Arm correspondence, events/people, denominators, and original estimator. Stored wording is linked here; the original content review remains incomplete.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Arm correspondence, events/people, denominators, and original estimator.
Referenced methods
M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap design; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design; M08 §8.2.2, M15 §15.3.1; Chamgap adaptation
N09 · What are the one-sided interval and noninferiority P value?
Required materials and conditions
One-sided confidence level, upper bound, testing hypothesis, and original P value
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: One-sided confidence level, upper bound, testing hypothesis, and original P value. Stored wording is linked here; the original content review remains incomplete.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: One-sided confidence level, upper bound, testing hypothesis, and original P value.
Referenced methods
M15 §15.3.1–15.3.3; Chamgap adaptation; M08 §8.2.2, M15 §15.3.1; Chamgap adaptation
N10 · What criterion does the prespecified +7-percentage-point margin represent?
Required materials and conditions
Rationale, direction, and timing of the noninferiority margin
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Rationale, direction, and timing of the noninferiority margin. Stored wording is linked here; the original content review remains incomplete.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Rationale, direction, and timing of the noninferiority margin.
Referenced methods
M15 §15.3.1–15.3.3; internal application; M08 Table 8.2.a, M04 §4.6.3; internal application
N11 · How is failure to demonstrate noninferiority preserved as a conclusion?
Required materials and conditions
Logical separation of demonstrating an acceptable margin from superiority in harm
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Logical separation of demonstrating an acceptable margin from superiority in harm. Stored wording is linked here; the original content review remains incomplete.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Logical separation of demonstrating an acceptable margin from superiority in harm.
Referenced methods
M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is Chamgap design; M15 §15.3.1–15.3.3; Chamgap adaptation; question-clarification principles in M03 §3.1, §3.2.1–3.2.4; detailed separation rules are Chamgap design
N12 · Which material addresses consistency in other analysis populations?
Required materials and conditions
ITT/other populations, denominators, quantitative results, and effect of interest
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: ITT/other populations, denominators, quantitative results, and effect of interest. Stored wording is linked here; the original content review remains incomplete.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: ITT/other populations, denominators, quantitative results, and effect of interest.
Referenced methods
M08 §8.2.2 and M15 §15.3.1: in-house application; M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4: design-specific adaptation is in-house.
N13 · Are cointerventions, rescue insulin, and adherence/switching known?
Required materials and conditions
Common dietary treatment, arm-specific treatment changes, rescue treatment, and handling of departures
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Common dietary treatment, arm-specific treatment changes, rescue treatment, and handling of departures. Stored wording is linked here; the original content review remains incomplete.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Common dietary treatment, arm-specific treatment changes, rescue treatment, and handling of departures.
Referenced methods
M03 §3.2.3, M08 §8.2.2–8.2.3; our own application; M08 §8.2.2, M15 §15.3.1; our own application
N14 · Were composite events measured under comparable conditions?
Required materials and conditions
Component measurement, testing, blinding, and differences in detection
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Component measurement, testing, blinding, and differences in detection. Stored wording is linked here; the original content review remains incomplete.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Component measurement, testing, blinding, and differences in detection.
Referenced methods
M08 Table 8.2.a, M03 §3.2.4; own application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific result adaptation is our own design
N15 · What was verified about registration, protocol, and SAP?
Required materials and conditions
Registration identity, prespecified primary analysis, margin, and change history
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Registration identity, prespecified primary analysis, margin, and change history. Stored wording is linked here; the original content review remains incomplete.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Registration identity, prespecified primary analysis, margin, and change history.
Referenced methods
M08 Table 8.2.a, M04 §4.6.3; Chamgap application; M04 §4.5–4.6 principles for collecting and selecting materials; separation of access and reading and hyperlink rules are Chamgap's own design
N16 · What are INDAO’s public funding and sponsor?
Required materials and conditions
PHRC public grant, AP-HP sponsor, and roles
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: PHRC public grant, AP-HP sponsor, and roles. Stored wording is linked here; the original content review remains incomplete.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: PHRC public grant, AP-HP sponsor, and roles.
Referenced methods
Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.
N17 · Are unreported commercial support and detailed COI distinguished?
Required materials and conditions
Commercial funding, study medication, author employment/patents, and analysis/writing support
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Commercial funding, study medication, author employment/patents, and analysis/writing support. Stored wording is linked here; the original content review remains incomplete.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Commercial funding, study medication, author employment/patents, and analysis/writing support.
Referenced methods
Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.
N18 · Did the earlier Langer trial have the same noninferiority framework?
Required materials and conditions
Earlier trial’s primary endpoint, design, population/comparison, and prespecified margin
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Earlier trial’s primary endpoint, design, population/comparison, and prespecified margin. Stored wording is linked here; the original content review remains incomplete.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Earlier trial’s primary endpoint, design, population/comparison, and prespecified margin.
Referenced methods
M04 §4.6.1–4.6.2, M15 §15.3.1; Chamgap adaptation; M03 §3.2.1; detailed population conditions are Chamgap design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap design; M08 Table 8.2.a, M04 §4.6.3; Chamgap adaptation
N19 · How are Langer’s individual complications and alternative conclusion preserved?
Required materials and conditions
LGA/hypoglycemia results, nonsignificance, and scope of the original conclusion
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: LGA/hypoglycemia results, nonsignificance, and scope of the original conclusion. Stored wording is linked here; the original content review remains incomplete.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: LGA/hypoglycemia results, nonsignificance, and scope of the original conclusion.
Referenced methods
M04 §4.6.3, M15 §15.3.1–15.3.3; status distinctions are our own design; M15 §15.3.1–15.3.3; own application; M04 §4.6.1–4.6.2, M15 §15.3.1; own application
N20 · Do Langer’s registration and funding entries establish actual identities?
Required materials and conditions
Original registration wording and actual support/COI information
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Original registration wording and actual support/COI information. Stored wording is linked here; the original content review remains incomplete.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Original registration wording and actual support/COI information.
Referenced methods
Chamgap’s own independence/attribution conditions. The official methodological sections in this pilot do not warrant all these detailed items; M08 Table 8.2.a, M04 §4.6.3; Chamgap adaptation; material-collection/selection principles in M04 §4.5–4.6; separation of access/reading and the hyperlink contract are Chamgap design
N21 · Do Helal’s overall review and RCT subgroup have the same denominator?
Required materials and conditions
Study designs, overall/RCT subsets, and endpoint-specific denominators
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Study designs, overall/RCT subsets, and endpoint-specific denominators. Stored wording is linked here; the original content review remains incomplete.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Study designs, overall/RCT subsets, and endpoint-specific denominators.
Referenced methods
Distinction between studies and reports in M04 §4.6.1–4.6.2; cohort/outcome linking is Chamgap adaptation; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design; M04 §4.6.1–4.6.2, M15 §15.3.1; Chamgap adaptation
N22 · Are RCT-subgroup and overall pooled results kept separate?
Required materials and conditions
Attribution of maternal/neonatal hypoglycemia, LGA, and analysis levels
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Attribution of maternal/neonatal hypoglycemia, LGA, and analysis levels. Stored wording is linked here; the original content review remains incomplete.
Requirement and applicability
Supplementary
Application exceptions
Supplement safety-material gaps for the selected subquestion. Do not turn failure to demonstrate noninferiority or the parent safety wording into conclusions about individual harms/significant superiority, or generate new incidence rates or medication-selection/use instructions for pregnant women.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Attribution of maternal/neonatal hypoglycemia, LGA, and analysis levels.
Referenced methods
M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is Chamgap design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap design; M19 §19.1.2–19.2.4; Chamgap adaptation; Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool
N23 · Are review support, registration, and protocol known?
Required materials and conditions
Funding/COI and plans for the review itself and its included trials
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Funding/COI and plans for the review itself and its included trials. Stored wording is linked here; the original content review remains incomplete.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Funding/COI and plans for the review itself and its included trials.
Referenced methods
Chamgap’s own independence/attribution conditions. The official methodological sections in this pilot do not warrant all these detailed items; M08 Table 8.2.a, M04 §4.6.3; Chamgap adaptation; material-collection/selection principles in M04 §4.5–4.6; separation of access/reading and the hyperlink contract are Chamgap design
N24 · Can component risks substitute for composite noninferiority?
Required materials and conditions
Individual values, definitions, and denominators for macrosomia, hypoglycemia, and hyperbilirubinemia
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Individual values, definitions, and denominators for macrosomia, hypoglycemia, and hyperbilirubinemia. Stored wording is linked here; the original content review remains incomplete.
Requirement and applicability
Supplementary
Application exceptions
Supplement safety-material gaps for the selected subquestion. Do not turn failure to demonstrate noninferiority or the parent safety wording into conclusions about individual harms/significant superiority, or generate new incidence rates or medication-selection/use instructions for pregnant women.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Individual values, definitions, and denominators for macrosomia, hypoglycemia, and hyperbilirubinemia.
Referenced methods
M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap design; M19 §19.1.2–19.2.4; Chamgap adaptation; M19 §19.1.2–19.2.4; detailed discrimination is Chamgap design
N25 · What is the scope of maternal hypoglycemia and other harms?
Required materials and conditions
Maternal events, arm-specific values, collection, period, and separation from neonatal outcomes
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Maternal events, arm-specific values, collection, period, and separation from neonatal outcomes. Stored wording is linked here; the original content review remains incomplete.
Requirement and applicability
Supplementary
Application exceptions
Supplement safety-material gaps for the selected subquestion. Do not turn failure to demonstrate noninferiority or the parent safety wording into conclusions about individual harms/significant superiority, or generate new incidence rates or medication-selection/use instructions for pregnant women.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Maternal events, arm-specific values, collection, period, and separation from neonatal outcomes.
Referenced methods
M19 §19.1.2–19.2.4; Chamgap adaptation; M19 §19.1.2–19.2.4; detailed distinctions are Chamgap design; M19 §19.1.2–19.2.4; Chamgap adaptation; M19 §19.1.2–19.2.4, M04 §4.6.3; Chamgap adaptation
N26 · How are the same reports/cohorts distinguished from independent replication?
Required materials and conditions
Relationships among INDAO, Langer, Helal, included trials, and subsequent reports
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Relationships among INDAO, Langer, Helal, included trials, and subsequent reports. Stored wording is linked here; the original content review remains incomplete.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Relationships among INDAO, Langer, Helal, included trials, and subsequent reports.
Referenced methods
Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application
N27 · Is the result extended to medications, periods, or clinical questions outside its scope?
Required materials and conditions
Other medications/classes, timing, long-term outcomes, convenience, and clinical evidence
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Other medications/classes, timing, long-term outcomes, convenience, and clinical evidence. Stored wording is linked here; the original content review remains incomplete.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Other medications/classes, timing, long-term outcomes, convenience, and clinical evidence.
Referenced methods
M03 §3.2.1–3.2.4; dose, persistence and effect-modification details are Chamgap's own design; M03 §3.2.4; Chamgap extension boundaries
N28 · What historical context do parent score, axes, bilingual manuscript, dates, and corrections provide?
Required materials and conditions
Original C54 verdict, language-specific wording, unrecorded/false/empty values, and correction history
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Original C54 verdict, language-specific wording, unrecorded/false/empty values, and correction history. Stored wording is linked here; the original content review remains incomplete.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Original C54 verdict, language-specific wording, unrecorded/false/empty values, and correction history.
Referenced methods
M04 §4.5, §4.6.3; current material-conversion limits reflect review scope and our own design; M04 §4.6.3, M15 §15.3.1–15.3.3; status distinctions are our own design
N29 · Are actual summary reading and unread external material separated?
Required materials and conditions
Existence, acquisition, actual reading, and original URLs for each material
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Existence, acquisition, actual reading, and original URLs for each material. Stored wording is linked here; the original content review remains incomplete.
Requirement and applicability
Required
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Existence, acquisition, actual reading, and original URLs for each material.
Referenced methods
M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design
Referenced methods and the sections actually reviewed

M03 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13

Referenced principle
Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.
Extent of review
Preserved method HTML copies; no current method-content re-review or official tool execution

M04 · Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03

Official methodology · §4.5, §4.6.1–4.6.3, MECIR C42

Referenced principle
Distinguish studies from reports and link them; do not omit a study solely because results are unreported.
Extent of review
Preserved method HTML copies; no current method-content re-review or official tool execution

M08 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §8.1–8.2.3, Table 8.2.a

Referenced principle
Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.
Extent of review
Preserved method HTML copies; no current method-content re-review or official tool execution

M15 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §15.2.4, §15.3.1–15.3.3

Referenced principle
Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.
Extent of review
Preserved method HTML copies; no current method-content re-review or official tool execution

M19 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §19.1.2, §19.2.1–19.2.4

Referenced principle
Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.
Extent of review
Preserved method HTML copies; no current method-content re-review or official tool execution
What the statuses mean
Met
Status for necessary evidence confirmed after existing content review. No completion is declared in the current presentation.
Partly verified
Some information in the stored summary is linked into the table. External comparison/content review is not complete.
Unverified
The article leaves this unverified, or required material is absent from the current stored summary. This is distinct from zero, absence or safety.
Review incomplete
Existing content review remains incomplete.
Not reported
Not reported within the stored material actually read; not extended to the entire primary paper.
Inaccessible
Means an actual access failure. Access not attempted here is not assigned this state.
Not applicable
Not used as a substitute for an evidence gap.
Conflicting data
Requires an observed disagreement under the same comparison criteria; not automatically judged in this production.
Insufficient evidence for the conditions
Marks a gap in additional material required by the selected conditions; not a new efficacy grade.

Change history

2026-10-11 · Public page/material version 1.0

Public pages and materials were created from the existing 29 items. No new clinical search, verification-status change or scoring was performed.

The stored-material review date (Not recorded) and original evidence cut-off (2026-08-26) were retained unchanged.

Researcher downloads

These materials provide the same evidence, scope and verification status as this page.

View all item details

N01 · Which existing noninferiority question is being turned into a table?

Current findings
The selected question is “Noninferiority to insulin for the perinatal composite”; subclaim C and “the CI upper bound of +10.5 percentage points exceeded the +7-percentage-point margin” are preserved. The parent is C54.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Subclaim score/status/axis keys are absent and are not filled from parent values. The sibling D question about harm superiority is separate. The original content review remains incomplete.
Reason for missing information
Subclaim score/status/axis keys are absent and are not filled from parent values. The sibling D question about harm superiority is separate.
Required materials and conditions
Separation of the selected question, subclaim grade, and parent context
Materials to obtain first
Correction records for the selected claim and parent assessment
Further research
Update while maintaining the selected question and verdict record separately. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
Remaining uncertainty
This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Separation of the selected question, subclaim grade, and parent context. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Separation of the selected question, subclaim grade, and parent context.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design

Related sources S01 S02 S03

N02 · What were the actual INDAO population and recruitment conditions?

Current findings
The original scope is women with gestational diabetes requiring medication even after 10 days of dietary treatment, at 13 French university hospitals.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Details of age, gestational week, diagnostic/glucose criteria, baseline risk, and inclusion/exclusion are unverified in this summary. The original content review remains incomplete.
Reason for missing information
Details of age, gestational week, diagnostic/glucose criteria, baseline risk, and inclusion/exclusion are unverified in this summary.
Required materials and conditions
Gestational diabetes, medication requirement, inclusion/exclusion, and gestational timing
Materials to obtain first
Recruitment criteria and baseline characteristics table
Further research
Distinguish the actual population from other pregnancy/diabetes populations. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
Remaining uncertainty
This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Gestational diabetes, medication requirement, inclusion/exclusion, and gestational timing. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Gestational diabetes, medication requirement, inclusion/exclusion, and gestational timing.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
M03 §3.2.1; detailed population conditions are Chamgap's own design

Related sources S01

N03 · What were the actual intervention and comparator?

Current findings
The manuscript records a comparison of oral sulfonylurea glyburide with injected insulin. This wording describes historical study conditions; it is not medication-selection or administration guidance.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Exact doses, escalation, actual exposure duration, insulin type/regimen, and arm-specific changes are unverified. The original content review remains incomplete.
Reason for missing information
Exact doses, escalation, actual exposure duration, insulin type/regimen, and arm-specific changes are unverified.
Required materials and conditions
Glyburide, subcutaneous insulin, study exposure, and comparison direction
Materials to obtain first
Study intervention, comparator, and exposure records
Further research
Link nominal assignment and actual exposure separately. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
Remaining uncertainty
This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Glyburide, subcutaneous insulin, study exposure, and comparison direction. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Glyburide, subcutaneous insulin, study exposure, and comparison direction.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application

Related sources S01

N04 · How much is known about design, allocation, and blinding?

Current findings
INDAO is a multicenter open-label randomized noninferiority trial. It assigned 914 participants: 460 to glyburide and 454 to insulin.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Allocation sequence, concealment, arm-specific baseline balance, and assessor/analyst blinding are unverified. The open-label design is not turned into a new failure judgment. The original content review remains incomplete.
Reason for missing information
Allocation sequence, concealment, arm-specific baseline balance, and assessor/analyst blinding are unverified. The open-label design is not turned into a new failure judgment.
Required materials and conditions
Open-label randomized noninferiority design, concealment, and baseline balance
Materials to obtain first
Allocation methods, baseline characteristics, and assessment-operation material
Further research
Separate the design label from operational details actually verified. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
Remaining uncertainty
This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Open-label randomized noninferiority design, concealment, and baseline balance. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Open-label randomized noninferiority design, concealment, and baseline balance.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
M08 §8.1–8.2.3; internal application; M08 Table 8.2.a, M03 §3.2.4; internal application

Related sources S01

N05 · How was the perinatal composite defined?

Current findings
The prespecified primary endpoint was a perinatal composite of at least one of macrosomia, neonatal hypoglycemia, or hyperbilirubinemia.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Component criteria, collection methods, neonatal denominators, handling of overlapping events, and exact period are unverified. The original content review remains incomplete.
Reason for missing information
Component criteria, collection methods, neonatal denominators, handling of overlapping events, and exact period are unverified.
Required materials and conditions
Composite-event definition, component criteria, and overlap counting
Materials to obtain first
Composite definition and component-event tables
Further research
Keep the composite and its individual components as different outcomes. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
Remaining uncertainty
This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Composite-event definition, component criteria, and overlap counting. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Composite-event definition, component criteria, and overlap counting.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are our own design

Related sources S01

N06 · How much is known about perinatal timing and the observation period?

Current findings
The manuscript describes a perinatal composite of actual birth-related events.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Treatment start/end, assessment windows around birth, and follow-up after discharge are unverified. The result is not extended to long-term offspring outcomes. The original content review remains incomplete.
Reason for missing information
Treatment start/end, assessment windows around birth, and follow-up after discharge are unverified. The result is not extended to long-term offspring outcomes.
Required materials and conditions
Medication exposure, assessment around birth, and follow-up scope
Materials to obtain first
Exposure schedule and perinatal/subsequent follow-up plan
Further research
Record exposure timing and event-assessment timing separately. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
Remaining uncertainty
This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Medication exposure, assessment around birth, and follow-up scope. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Medication exposure, assessment around birth, and follow-up scope.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed

Related sources S01

N07 · Are the prespecified primary PP analysis and randomized denominator distinguished?

Current findings
Original values are preserved: 914 randomized (460/454) and 809 in the prespecified primary PP analysis (367/442).
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. PP definition, arm-specific reasons for exclusion/switching, and neonatal analysis units are unverified. No new exclusion counts or rates are calculated. The original content review remains incomplete.
Reason for missing information
PP definition, arm-specific reasons for exclusion/switching, and neonatal analysis units are unverified. No new exclusion counts or rates are calculated.
Required materials and conditions
Randomization, PP, arm-specific exclusions/switching, and analysis denominators
Materials to obtain first
Flow diagram, PP definition, and arm-specific analysis tables
Further research
Distinguish assignment, actual exposure, maternal/neonatal observations, and analysis denominators. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
Remaining uncertainty
This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Randomization, PP, arm-specific exclusions/switching, and analysis denominators. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Randomization, PP, arm-specific exclusions/switching, and analysis denominators.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application

Related sources S01

N08 · Which population do the observed rates and absolute difference describe?

Current findings
The original INDAO perinatal-composite result is 27.6% with glyburide versus 23.4% with insulin, an absolute difference of +4.2 percentage points. It is linked to the prespecified primary PP analysis context.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Unrounded rates, event counts, and exact maternal/neonatal denominator correspondence are unverified. No event counts or new differences are calculated from rates. The original content review remains incomplete.
Reason for missing information
Unrounded rates, event counts, and exact maternal/neonatal denominator correspondence are unverified. No event counts or new differences are calculated from rates.
Required materials and conditions
Arm correspondence, events/people, denominators, and original estimator
Materials to obtain first
PP composite-result table and analysis-unit definitions
Further research
Attribute original rates, differences, and denominators individually. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
Remaining uncertainty
This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Arm correspondence, events/people, denominators, and original estimator. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Arm correspondence, events/people, denominators, and original estimator.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap design; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design; M08 §8.2.2, M15 §15.3.1; Chamgap adaptation

Related sources S01

N09 · What are the one-sided interval and noninferiority P value?

Current findings
The original one-sided 97.5% CI upper bound of +10.5 percentage points and noninferiority P=0.19 are preserved.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. The lower bound, full interval, calculation model, and superiority-test CI/P are unverified in this summary. No new two-sided CI or superiority P is calculated from the one-sided upper bound. The original content review remains incomplete.
Reason for missing information
The lower bound, full interval, calculation model, and superiority-test CI/P are unverified in this summary. No new two-sided CI or superiority P is calculated from the one-sided upper bound.
Required materials and conditions
One-sided confidence level, upper bound, testing hypothesis, and original P value
Materials to obtain first
Noninferiority analysis table and SAP
Further research
Distinguish noninferiority and superiority test quantities. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
Remaining uncertainty
This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: One-sided confidence level, upper bound, testing hypothesis, and original P value. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: One-sided confidence level, upper bound, testing hypothesis, and original P value.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
M15 §15.3.1–15.3.3; Chamgap adaptation; M08 §8.2.2, M15 §15.3.1; Chamgap adaptation

Related sources S01

N10 · What criterion does the prespecified +7-percentage-point margin represent?

Current findings
The manuscript declares a prespecified +7-percentage-point margin and records that the one-sided upper bound of +10.5 percentage points exceeded it.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Clinical/statistical rationale for the margin, the original prespecified plan, and sample-size assumptions remain unread. The original content review remains incomplete.
Reason for missing information
Clinical/statistical rationale for the margin, the original prespecified plan, and sample-size assumptions remain unread.
Required materials and conditions
Rationale, direction, and timing of the noninferiority margin
Materials to obtain first
Protocol, margin rationale, and sample-size plan
Further research
Distinguish the original margin from criteria in newly supplied material. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
Remaining uncertainty
This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Rationale, direction, and timing of the noninferiority margin. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Rationale, direction, and timing of the noninferiority margin.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
M15 §15.3.1–15.3.3; internal application; M08 Table 8.2.a, M04 §4.6.3; internal application

Related sources S01

N11 · How is failure to demonstrate noninferiority preserved as a conclusion?

Current findings
The manuscript states that being within the acceptable margin was not demonstrated, and explicitly distinguishes this from demonstrating significantly worse results.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. No new conclusion of an exactly zero effect, equivalence, or significant harm is created. A separate superiority plan/analysis is unverified. The original content review remains incomplete.
Reason for missing information
No new conclusion of an exactly zero effect, equivalence, or significant harm is created. A separate superiority plan/analysis is unverified.
Required materials and conditions
Logical separation of demonstrating an acceptable margin from superiority in harm
Materials to obtain first
Superiority plan/results and original noninferiority conclusion
Further research
Separate design-specific questions and the scope of the original conclusion. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
Remaining uncertainty
This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Logical separation of demonstrating an acceptable margin from superiority in harm. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Logical separation of demonstrating an acceptable margin from superiority in harm.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is Chamgap design; M15 §15.3.1–15.3.3; Chamgap adaptation; question-clarification principles in M03 §3.1, §3.2.1–3.2.4; detailed separation rules are Chamgap design

Related sources S01

N12 · Which material addresses consistency in other analysis populations?

Current findings
The manuscript says other analysis populations were used to assess consistency.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Their names, denominators, original effects/CIs, missing-data handling, and values relative to PP are unverified. They are not arbitrarily filled as quantitative ITT confirmation. The original content review remains incomplete.
Reason for missing information
Their names, denominators, original effects/CIs, missing-data handling, and values relative to PP are unverified. They are not arbitrarily filled as quantitative ITT confirmation.
Required materials and conditions
ITT/other populations, denominators, quantitative results, and effect of interest
Materials to obtain first
Additional analysis populations, sensitivity results, and SAP
Further research
Link the primary PP analysis and actual supplementary analyses separately. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
Remaining uncertainty
This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: ITT/other populations, denominators, quantitative results, and effect of interest. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: ITT/other populations, denominators, quantitative results, and effect of interest.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
M08 §8.2.2 and M15 §15.3.1: in-house application; M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4: design-specific adaptation is in-house.

Related sources S01

N13 · Are cointerventions, rescue insulin, and adherence/switching known?

Current findings
The stored summary describes a population requiring medication after dietary treatment and a glyburide/insulin comparison.
Verification status
Unverified
Materials actually read
Summary read; external material unread
Why unverified
Currently required information in the stored summary is unverified. Arm-specific rescue treatment, switching, dose/adherence, concomitant care, and analytical handling are unverified. Actual switching is not invented. The original content review remains incomplete.
Reason for missing information
Arm-specific rescue treatment, switching, dose/adherence, concomitant care, and analytical handling are unverified. Actual switching is not invented.
Required materials and conditions
Common dietary treatment, arm-specific treatment changes, rescue treatment, and handling of departures
Materials to obtain first
Arm-specific adherence, concomitant treatment, and switching/rescue-treatment records
Further research
Link assignment and treatment departures to the effect being estimated. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
Remaining uncertainty
This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Common dietary treatment, arm-specific treatment changes, rescue treatment, and handling of departures. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Common dietary treatment, arm-specific treatment changes, rescue treatment, and handling of departures.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
M03 §3.2.3, M08 §8.2.2–8.2.3; our own application; M08 §8.2.2, M15 §15.3.1; our own application

Related sources S01

N14 · Were composite events measured under comparable conditions?

Current findings
The original description of a perinatal composite in an open-label trial is preserved.
Verification status
Unverified
Materials actually read
Summary read; external material unread
Why unverified
Currently required information in the stored summary is unverified. Measurement criteria/schedules for macrosomia, hypoglycemia, and hyperbilirubinemia, missed tests, and decision-maker blinding are unverified. The original content review remains incomplete.
Reason for missing information
Measurement criteria/schedules for macrosomia, hypoglycemia, and hyperbilirubinemia, missed tests, and decision-maker blinding are unverified.
Required materials and conditions
Component measurement, testing, blinding, and differences in detection
Materials to obtain first
Component-event adjudication and measurement-operation material
Further research
Distinguish objective event names from actual measurement conditions. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
Remaining uncertainty
This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Component measurement, testing, blinding, and differences in detection. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Component measurement, testing, blinding, and differences in detection.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
M08 Table 8.2.a, M03 §3.2.4; own application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific result adaptation is our own design

Related sources S01

N15 · What was verified about registration, protocol, and SAP?

Current findings
The original registration identifier is NCT01731431. Preserved descriptions of prespecified PP, the primary composite, and +7 percentage points are linked.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Registration, protocol, SAP, and change history remain unread; access was not attempted. The number is not treated as review of agreement with the plan. The original content review remains incomplete.
Reason for missing information
Registration, protocol, SAP, and change history remain unread; access was not attempted. The number is not treated as review of agreement with the plan.
Required materials and conditions
Registration identity, prespecified primary analysis, margin, and change history
Materials to obtain first
Registration history, protocol, and SAP
Further research
If material is supplied, record prespecification, changes, and reporting separately. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
Remaining uncertainty
This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Registration identity, prespecified primary analysis, margin, and change history. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Registration identity, prespecified primary analysis, margin, and change history.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
M08 Table 8.2.a, M04 §4.6.3; Chamgap application; M04 §4.5–4.6 principles for collecting and selecting materials; separation of access and reading and hyperlink rules are Chamgap's own design

Related sources S01

N16 · What are INDAO’s public funding and sponsor?

Current findings
The French Ministry of Health Programme Hospitalier de Recherche Clinique public grant and Assistance Publique–Hôpitaux de Paris public sponsor support are preserved as originally recorded.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Contracts, itemized amounts, and actual design/analysis/writing roles are unverified. Public funding is not extended to confirmation of all independence criteria. The original content review remains incomplete.
Reason for missing information
Contracts, itemized amounts, and actual design/analysis/writing roles are unverified. Public funding is not extended to confirmation of all independence criteria.
Required materials and conditions
PHRC public grant, AP-HP sponsor, and roles
Materials to obtain first
Funding/sponsor and role disclosures
Further research
Link funding provision and research roles separately. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
Remaining uncertainty
This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: PHRC public grant, AP-HP sponsor, and roles. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: PHRC public grant, AP-HP sponsor, and roles.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.

Related sources S01

N17 · Are unreported commercial support and detailed COI distinguished?

Current findings
The manuscript records that commercial pharmaceutical funding or free study medication was not reported.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Actual absence was not newly established. Employee authors, patents, outsourced analysis, individual COI, and writing/publication support details are unverified. The original content review remains incomplete.
Reason for missing information
Actual absence was not newly established. Employee authors, patents, outsourced analysis, individual COI, and writing/publication support details are unverified.
Required materials and conditions
Commercial funding, study medication, author employment/patents, and analysis/writing support
Materials to obtain first
Original funding/product and author/COI disclosures
Further research
Distinguish the reporting scope from separately unverified relationships. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
Remaining uncertainty
This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Commercial funding, study medication, author employment/patents, and analysis/writing support. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Commercial funding, study medication, author employment/patents, and analysis/writing support.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.

Related sources S01

N18 · Did the earlier Langer trial have the same noninferiority framework?

Current findings
Langer 2000 was a 404-participant glyburide-versus-insulin RCT. The manuscript records primary glycemic control and secondary individual perinatal complications, without a prespecified noninferiority test.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Detailed population, denominators, duration, glycemic-control values, and original plan remain unread. It is not counted as replication of the same perinatal-composite noninferiority question. The original content review remains incomplete.
Reason for missing information
Detailed population, denominators, duration, glycemic-control values, and original plan remain unread. It is not counted as replication of the same perinatal-composite noninferiority question.
Required materials and conditions
Earlier trial’s primary endpoint, design, population/comparison, and prespecified margin
Materials to obtain first
Langer plan, population, and result tables
Further research
Maintain different questions for the primary endpoint and secondary outcomes. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
Remaining uncertainty
This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Earlier trial’s primary endpoint, design, population/comparison, and prespecified margin. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Earlier trial’s primary endpoint, design, population/comparison, and prespecified margin.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
M04 §4.6.1–4.6.2, M15 §15.3.1; Chamgap adaptation; M03 §3.2.1; detailed population conditions are Chamgap design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap design; M08 Table 8.2.a, M04 §4.6.3; Chamgap adaptation

Related sources S03

N19 · How are Langer’s individual complications and alternative conclusion preserved?

Current findings
LGA 12% versus 13%, neonatal hypoglycemia 9% versus 6%, no significant difference in individual complications, and the “clinically effective alternative” conclusion are preserved as originally recorded.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Original CI/P, denominators, and definitions are unverified. Nonsignificance is not changed into being within an acceptable margin, equivalence, or reversal of INDAO. The original content review remains incomplete.
Reason for missing information
Original CI/P, denominators, and definitions are unverified. Nonsignificance is not changed into being within an acceptable margin, equivalence, or reversal of INDAO.
Required materials and conditions
LGA/hypoglycemia results, nonsignificance, and scope of the original conclusion
Materials to obtain first
Individual-result tables and original conclusion
Further research
Record the earlier opposing conclusion together with actual design differences. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
Remaining uncertainty
This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: LGA/hypoglycemia results, nonsignificance, and scope of the original conclusion. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: LGA/hypoglycemia results, nonsignificance, and scope of the original conclusion.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
M04 §4.6.3, M15 §15.3.1–15.3.3; status distinctions are our own design; M15 §15.3.1–15.3.3; own application; M04 §4.6.1–4.6.2, M15 §15.3.1; own application

Related sources S03

N20 · Do Langer’s registration and funding entries establish actual identities?

Current findings
The nct entry “not applicable” and funding entry “reported in the original paper” are preserved as originally recorded. The latter is not a verified provider name.
Verification status
Unverified
Materials actually read
Summary read; external material unread
Why unverified
Currently required information in the stored summary is unverified. Existence of registration/plans and actual funding, product support, and author COI are unverified. “Not applicable” is not used as current certification of absence. The original content review remains incomplete.
Reason for missing information
Existence of registration/plans and actual funding, product support, and author COI are unverified. “Not applicable” is not used as current certification of absence.
Required materials and conditions
Original registration wording and actual support/COI information
Materials to obtain first
Original Langer plan and funding/COI material
Further research
Separate wording from actual identifiers and disclosure information. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
Remaining uncertainty
This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Original registration wording and actual support/COI information. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Original registration wording and actual support/COI information.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
Chamgap’s own independence/attribution conditions. The official methodological sections in this pilot do not warrant all these detailed items; M08 Table 8.2.a, M04 §4.6.3; Chamgap adaptation; material-collection/selection principles in M04 §4.5–4.6; separation of access/reading and the hyperlink contract are Chamgap design

Related sources S03

N21 · Do Helal’s overall review and RCT subgroup have the same denominator?

Current findings
The original review records 24 studies with a total of 24,517 participants and an 11-RCT subgroup analysis.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. The RCT subgroup participant count, endpoint-specific denominators, and included-trial/overlap tables are unverified. The overall 24,517 is not repurposed as the 11-RCT denominator or newly summed with INDAO/Langer. The original content review remains incomplete.
Reason for missing information
The RCT subgroup participant count, endpoint-specific denominators, and included-trial/overlap tables are unverified. The overall 24,517 is not repurposed as the 11-RCT denominator or newly summed with INDAO/Langer.
Required materials and conditions
Study designs, overall/RCT subsets, and endpoint-specific denominators
Materials to obtain first
Included-study table and design/endpoint-specific analysis tables
Further research
Link overall synthesis and RCT subgroup analyses separately. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
Remaining uncertainty
This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Study designs, overall/RCT subsets, and endpoint-specific denominators. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Study designs, overall/RCT subsets, and endpoint-specific denominators.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
Distinction between studies and reports in M04 §4.6.1–4.6.2; cohort/outcome linking is Chamgap adaptation; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design; M04 §4.6.1–4.6.2, M15 §15.3.1; Chamgap adaptation

Related sources S02

N22 · Are RCT-subgroup and overall pooled results kept separate?

Current findings
S02’s evidence list distinguishes increased maternal hypoglycemia and LGA in the RCT subgroup from overall pooled neonatal hypoglycemia OR 1.42 (95% CI 1.03–1.95).
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. The Korean/English manuscript’s safety explanation describes increased neonatal hypoglycemia and LGA in the RCT subgroup, differing in specific attribution from the evidence list. Both wordings are preserved while the original paper remains unread; no automatic resolution or reassessment to a new analysis level is made. The original content review remains incomplete.
Reason for missing information
The Korean/English manuscript’s safety explanation describes increased neonatal hypoglycemia and LGA in the RCT subgroup, differing in specific attribution from the evidence list. Both wordings are preserved while the original paper remains unread; no automatic resolution or reassessment to a new analysis level is made.
Required materials and conditions
Attribution of maternal/neonatal hypoglycemia, LGA, and analysis levels
Materials to obtain first
Review tables of endpoint-specific overall/RCT results and original disclosures
Further research
If the original paper explains the wording difference, distinguish the source and correction event. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
Remaining uncertainty
This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Attribution of maternal/neonatal hypoglycemia, LGA, and analysis levels. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Attribution of maternal/neonatal hypoglycemia, LGA, and analysis levels.
Application exceptions
Supplement safety-material gaps for the selected subquestion. Do not turn failure to demonstrate noninferiority or the parent safety wording into conclusions about individual harms/significant superiority, or generate new incidence rates or medication-selection/use instructions for pregnant women.
Referenced methods
M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is Chamgap design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap design; M19 §19.1.2–19.2.4; Chamgap adaptation; Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool

Related sources S02

N23 · Are review support, registration, and protocol known?

Current findings
The funding entry “systematic review; included-trial funding mixed” and nct entry “not applicable” are preserved as originally recorded.
Verification status
Unverified
Materials actually read
Summary read; external material unread
Why unverified
Currently required information in the stored summary is unverified. The review’s own funding/COI, registration/plans, and each included trial’s disclosures are unverified. Mixed support is not changed into identical independence or actual absence. The original content review remains incomplete.
Reason for missing information
The review’s own funding/COI, registration/plans, and each included trial’s disclosures are unverified. Mixed support is not changed into identical independence or actual absence.
Required materials and conditions
Funding/COI and plans for the review itself and its included trials
Materials to obtain first
Review plan, funding/COI, and included-trial disclosures
Further research
Record roles/support for the review and included trials separately. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
Remaining uncertainty
This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Funding/COI and plans for the review itself and its included trials. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Funding/COI and plans for the review itself and its included trials.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
Chamgap’s own independence/attribution conditions. The official methodological sections in this pilot do not warrant all these detailed items; M08 Table 8.2.a, M04 §4.6.3; Chamgap adaptation; material-collection/selection principles in M04 §4.5–4.6; separation of access/reading and the hyperlink contract are Chamgap design

Related sources S02

N24 · Can component risks substitute for composite noninferiority?

Current findings
INDAO’s primary endpoint is a composite of at least one of three events. Langer’s LGA/neonatal hypoglycemia and Helal’s individual safety results are separate endpoints.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. INDAO component-level quantitative results, multiplicity, and denominators are unverified. Macrosomia and LGA definitions are not filled as identical, and individual results are not transferred to the composite. The original content review remains incomplete.
Reason for missing information
INDAO component-level quantitative results, multiplicity, and denominators are unverified. Macrosomia and LGA definitions are not filled as identical, and individual results are not transferred to the composite.
Required materials and conditions
Individual values, definitions, and denominators for macrosomia, hypoglycemia, and hyperbilirubinemia
Materials to obtain first
INDAO component-result tables and event definitions in each report
Further research
Separate the composite, components, and events in other material. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
Remaining uncertainty
This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Individual values, definitions, and denominators for macrosomia, hypoglycemia, and hyperbilirubinemia. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Individual values, definitions, and denominators for macrosomia, hypoglycemia, and hyperbilirubinemia.
Application exceptions
Supplement safety-material gaps for the selected subquestion. Do not turn failure to demonstrate noninferiority or the parent safety wording into conclusions about individual harms/significant superiority, or generate new incidence rates or medication-selection/use instructions for pregnant women.
Referenced methods
M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap design; M19 §19.1.2–19.2.4; Chamgap adaptation; M19 §19.1.2–19.2.4; detailed discrimination is Chamgap design

Related sources S01 S02 S03

N25 · What is the scope of maternal hypoglycemia and other harms?

Current findings
The manuscript records more frequent maternal hypoglycemia in the glyburide arm. This is not repurposed as significant superiority in harm for the entire perinatal composite.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Arm-specific counts, denominators, CI/P, definitions, severity, other adverse events, and discontinuation information are unverified. No new incidence rates, causality conclusions, or safety grades are created. The original content review remains incomplete.
Reason for missing information
Arm-specific counts, denominators, CI/P, definitions, severity, other adverse events, and discontinuation information are unverified. No new incidence rates, causality conclusions, or safety grades are created.
Required materials and conditions
Maternal events, arm-specific values, collection, period, and separation from neonatal outcomes
Materials to obtain first
Maternal adverse-event, discontinuation, and arm-specific result tables
Further research
Maintain maternal and neonatal event units and comparisons separately. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
Remaining uncertainty
This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Maternal events, arm-specific values, collection, period, and separation from neonatal outcomes. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Maternal events, arm-specific values, collection, period, and separation from neonatal outcomes.
Application exceptions
Supplement safety-material gaps for the selected subquestion. Do not turn failure to demonstrate noninferiority or the parent safety wording into conclusions about individual harms/significant superiority, or generate new incidence rates or medication-selection/use instructions for pregnant women.
Referenced methods
M19 §19.1.2–19.2.4; Chamgap adaptation; M19 §19.1.2–19.2.4; detailed distinctions are Chamgap design; M19 §19.1.2–19.2.4; Chamgap adaptation; M19 §19.1.2–19.2.4, M04 §4.6.3; Chamgap adaptation

Related sources S01 S02

N26 · How are the same reports/cohorts distinguished from independent replication?

Current findings
INDAO/NCT01731431, Langer 2000, and the Helal 2020 review are linked as separate report items. The two sibling sheets share the same stored summary and reports.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Review inclusion, subsequent reports, and trial-identity overlaps were not checked. Original R1/E~ are not used as new replication/independence certification; unique clinical totals remain unrecorded. The original content review remains incomplete.
Reason for missing information
Review inclusion, subsequent reports, and trial-identity overlaps were not checked. Original R1/E~ are not used as new replication/independence certification; unique clinical totals remain unrecorded.
Required materials and conditions
Relationships among INDAO, Langer, Helal, included trials, and subsequent reports
Materials to obtain first
Related/included-trial tables and registration/report links
Further research
Distinguish report counts from unique clinical-trial and participant counts. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
Remaining uncertainty
This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Relationships among INDAO, Langer, Helal, included trials, and subsequent reports. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Relationships among INDAO, Langer, Helal, included trials, and subsequent reports.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application

Related sources S01 S02 S03

N27 · Is the result extended to medications, periods, or clinical questions outside its scope?

Current findings
The manuscript records that sulfonylurea placental transfer varies by drug and is not generalized to the entire class. Oral convenience is not noninferiority evidence.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Direct evidence for other drugs, conditions, pregnancy periods, and long-term offspring outcomes is unverified. No medication-selection, substitution, or administration instructions for pregnant women are created. The original content review remains incomplete.
Reason for missing information
Direct evidence for other drugs, conditions, pregnancy periods, and long-term offspring outcomes is unverified. No medication-selection, substitution, or administration instructions for pregnant women are created.
Required materials and conditions
Other medications/classes, timing, long-term outcomes, convenience, and clinical evidence
Materials to obtain first
Separate medication/population and long-term-outcome material
Further research
Separate the original noninferiority question from extension questions. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
Remaining uncertainty
This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Other medications/classes, timing, long-term outcomes, convenience, and clinical evidence. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Other medications/classes, timing, long-term outcomes, convenience, and clinical evidence.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
M03 §3.2.1–3.2.4; dose, persistence and effect-modification details are Chamgap's own design; M03 §3.2.4; Chamgap extension boundaries

Related sources S01 S02 S03

N28 · What historical context do parent score, axes, bilingual manuscript, dates, and corrections provide?

Current findings
C54, safety Caution, unrecorded precision in the original axes, false values, empty override reasons, Korean/English manuscripts, 2026-08-26, empty correction/deliberation values, and historical cross-checking are preserved in the full stored summary.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. This is not a current search, correction/retraction check, or completed content review. Parent scores or axes are not filled into subclaims C/D. The original content review remains incomplete.
Reason for missing information
This is not a current search, correction/retraction check, or completed content review. Parent scores or axes are not filled into subclaims C/D.
Required materials and conditions
Original C54 verdict, language-specific wording, unrecorded/false/empty values, and correction history
Materials to obtain first
New corrections, user comments, and supplied original material
Further research
Separate original records from production and correction events. This is a proposal; no new investigation, calculation, or trial was performed.
Remaining uncertainty
This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Original C54 verdict, language-specific wording, unrecorded/false/empty values, and correction history. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Original C54 verdict, language-specific wording, unrecorded/false/empty values, and correction history.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
M04 §4.5, §4.6.3; current material-conversion limits reflect review scope and our own design; M04 §4.6.3, M15 §15.3.1–15.3.3; status distinctions are our own design

Related sources S01 S02 S03

N29 · Are actual summary reading and unread external material separated?

Current findings
The full stored summary’s three evidence entries, three citations, Korean/English manuscripts, and selected item were read for production. Summaries are marked “summary read”; external papers, registration/plans, and disclosures are marked “unread”, with original source links connected.
Verification status
Partly verified
Materials actually read
Summary read; external material unread
Why unverified
Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. External abstracts/full texts, registration, protocols, SAPs, and disclosures were not accessed, clicked, or link-tested. Not attempted is not marked inaccessible. The original content review remains incomplete.
Reason for missing information
External abstracts/full texts, registration, protocols, SAPs, and disclosures were not accessed, clicked, or link-tested. Not attempted is not marked inaccessible.
Required materials and conditions
Existence, acquisition, actual reading, and original URLs for each material
Materials to obtain first
Original material and actual reading history for each report
Further research
Update material types and access/reading levels separately. This is a proposal; no new investigation, calculation, or trial was performed in the recorded work.
Remaining uncertainty
This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification
Corresponding original material and analysis scope must be supplied, with unverified matters distinguished, for: Existence, acquisition, actual reading, and original URLs for each material. Stored wording is linked here; the original content review remains incomplete.
Why this condition is needed
A production item connecting required and available material for the selected question by distinguishing: Existence, acquisition, actual reading, and original URLs for each material.
Application exceptions
Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods
M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design

Related sources S01 S02 S03