# Glyburide × noninferiority to insulin for the perinatal composite: evidence checklist Verdict 2949 · Evidence Check Stored-material review date: Not recorded Original evidence cut-off: 2026-08-26 Review-criteria version: 1.0 Public page/material preparation date: 2026-10-11 Clinical papers were not read directly; existing review summaries were checked. No new clinical-literature search was performed. Unverified does not mean that research is absent or that there is no effect. ## Assessment scope - 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 ## Checklist items ### N01 · Which existing noninferiority question is being turned into a table? Verification status: Partly verified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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? Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: The original scope is women with gestational diabetes requiring medication even after 10 days of dietary treatment, at 13 French university hospitals. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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? Verification status: Partly verified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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? Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: INDAO is a multicenter open-label randomized noninferiority trial. It assigned 914 participants: 460 to glyburide and 454 to insulin. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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? Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: The prespecified primary endpoint was a perinatal composite of at least one of macrosomia, neonatal hypoglycemia, or hyperbilirubinemia. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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? Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: The manuscript describes a perinatal composite of actual birth-related events. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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? Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: Original values are preserved: 914 randomized (460/454) and 809 in the prespecified primary PP analysis (367/442). - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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? Verification status: Partly verified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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? Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: The original one-sided 97.5% CI upper bound of +10.5 percentage points and noninferiority P=0.19 are preserved. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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? Verification status: Partly verified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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? Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: The manuscript states that being within the acceptable margin was not demonstrated, and explicitly distinguishes this from demonstrating significantly worse results. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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? Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: The manuscript says other analysis populations were used to assess consistency. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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? Verification status: Unverified Reading scope: Summary read; external material unread - Current findings: The stored summary describes a population requiring medication after dietary treatment and a glyburide/insulin comparison. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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? Verification status: Unverified Reading scope: Summary read; external material unread - Current findings: The original description of a perinatal composite in an open-label trial is preserved. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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? Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: The original registration identifier is NCT01731431. Preserved descriptions of prespecified PP, the primary composite, and +7 percentage points are linked. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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? Verification status: Partly verified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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? Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: The manuscript records that commercial pharmaceutical funding or free study medication was not reported. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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? Verification status: Partly verified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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? Verification status: Partly verified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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? Verification status: Unverified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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? Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: The original review records 24 studies with a total of 24,517 participants and an 11-RCT subgroup analysis. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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? Verification status: Partly verified Reading scope: Summary read; external material unread - 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). - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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? Verification status: Unverified Reading scope: Summary read; external material unread - Current findings: The funding entry “systematic review; included-trial funding mixed” and nct entry “not applicable” are preserved as originally recorded. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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? Verification status: Partly verified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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? Verification status: Partly verified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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? Verification status: Partly verified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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? Verification status: Partly verified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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? Verification status: Partly verified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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? Verification status: Partly verified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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 ## Evidence and sources ### S01 Sénat MV et al. 2018 INDAO [PubMed](https://pubmed.ncbi.nlm.nih.gov/29715355/) Materials actually read: Summary read; external material unread Findings recorded in the 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 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. | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | Stored summary | Stored file | Stored summary | Summary read | Only stored-summary and bibliographic content was used for production. External material verification/review is not complete. | | External paper | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. | | Registration material | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. | | Protocol | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. | | Statistical analysis plan | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No 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 material | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No 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](https://pubmed.ncbi.nlm.nih.gov/31989292/) Materials actually read: Summary read; external material unread Findings recorded in the 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 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. | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | Stored summary | Stored file | Stored summary | Summary read | Only stored-summary and bibliographic content was used for production. External material verification/review is not complete. | | External paper | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. | | Registration material | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. | | Protocol | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. | | Statistical analysis plan | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No 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 material | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No 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](https://pubmed.ncbi.nlm.nih.gov/11036118/) Materials actually read: Summary read; external material unread Findings recorded in the 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 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. | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | Stored summary | Stored file | Stored summary | Summary read | Only stored-summary and bibliographic content was used for production. External material verification/review is not complete. | | External paper | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. | | Registration material | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. | | Protocol | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. | | Statistical analysis plan | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No 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 material | Public availability unverified; only bibliography links preserved | Unread; access not attempted | Not read | No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status. | ## Review criteria and methods These are Chamgap's own application conditions, informed by the relevant sections of official methodological guidance. They do not constitute official assessment-tool certification or a new efficacy score. - M03 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03) · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13 · Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04) · §4.5, §4.6.1–4.6.3, MECIR C42 · Distinguish studies from reports and link them; do not omit a study solely because results are unreported. · Preserved method HTML copies; no current method-content re-review or official tool execution - M08 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08) · §8.1–8.2.3, Table 8.2.a · Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting. · Preserved method HTML copies; no current method-content re-review or official tool execution - M15 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15) · §15.2.4, §15.3.1–15.3.3 · Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision. · Preserved method HTML copies; no current method-content re-review or official tool execution - M19 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19) · §19.1.2, §19.2.1–19.2.4 · Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates. · 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/materials 1.0. Public pages and materials were created from the existing 29 items. No new clinical search, verification-status change or scoring was performed.