# Glyburide × superiority conclusion of significantly greater harm than insulin: 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: Original gestational-diabetes population requiring medication; shared with the sibling noninferiority sheet - Ingredient, formulation and route: Original study: glyburide; assignment/actual exposure/concomitant treatment/switching unverified - Dose: Not recorded - Comparator: Insulin; observed direction separated from harm-superiority testing - Measured outcome: Superiority conclusion that glyburide is significantly more harmful; INDAO note: unconfirmed; composite/individual harms distinguished - Duration: Perinatal context; exact event period/long-term outcomes 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 · What existing verdict accompanies the selected harm-superiority question? Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: The selected question is “Superiority conclusion that glyburide is significantly more harmful”; D and “INDAO did not confirm that conclusion” are preserved. Sibling noninferiority C and parent C54 are separate contexts. - Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Subclaim score/status/axes are absent and are not filled from parent values. Failure to demonstrate noninferiority is not changed into confirmation of superiority in harm. The original content review remains incomplete. - Reason for missing information: Subclaim score/status/axes are absent and are not filled from parent values. Failure to demonstrate noninferiority is not changed into confirmation of superiority in harm. - Required materials and conditions: Exact claim, subclaim D/note, and separation from parent C54 - Materials to obtain first: Correction records for the selected claim and parent assessment - Further research: Maintain the two questions’ pointers and verdict contexts 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: Exact claim, subclaim D/note, and separation from parent C54. 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: Exact claim, subclaim D/note, and separation from parent C54. - 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 Chamgap design; Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool - Related sources: S01, S02, S03 ### N02 · Which events and population are compared by “more harmful”? Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: The original context is a glyburide-versus-insulin perinatal comparison in gestational diabetes requiring medication. The INDAO composite and individual maternal/neonatal events are separated. - Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. The selected item itself supplies no additional definition of a particular individual harm or quantitative superiority. It is not extended to all harms/all pregnancy populations. The original content review remains incomplete. - Reason for missing information: The selected item itself supplies no additional definition of a particular individual harm or quantitative superiority. It is not extended to all harms/all pregnancy populations. - Required materials and conditions: Fixed harm-event definitions, population, comparator, and period - Materials to obtain first: Prespecified superiority-question definition and event-specific results - Further research: Attribute harm questions separately to the perinatal composite and individual events. 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: Fixed harm-event definitions, population, comparator, and period. 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: Fixed harm-event definitions, population, comparator, and period. - 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 design; M19 §19.1.2–19.2.4; detailed discrimination is Chamgap design; M19 §19.2.2–19.2.4, M03 §3.2.3; Chamgap adaptation; Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool - Related sources: S01 ### N03 · Are population, pregnancy timing, and baseline risk known? Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: The original scope of 13 French university hospitals and gestational diabetes requiring medication even after 10 days of dietary treatment is preserved. - Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Age, gestational week, diagnostic/glucose criteria, baseline events/risk, and inclusion/exclusion are unverified. The original content review remains incomplete. - Reason for missing information: Age, gestational week, diagnostic/glucose criteria, baseline events/risk, and inclusion/exclusion are unverified. - Required materials and conditions: Actual recruitment conditions, medication requirement, and baseline risk - Materials to obtain first: Recruitment, baseline-characteristic, and risk tables - Further research: Separate the scope for other pregnancy/diabetes populations and vulnerable groups. 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: Actual recruitment conditions, medication requirement, and baseline risk. 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: Actual recruitment conditions, medication requirement, and baseline risk. - 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 design; M19 §19.2.2–19.2.4 design considerations; detailed confounding records are Chamgap design; M19 §19.1.2–19.2.4; Chamgap adaptation - Related sources: S01 ### N04 · What are actual exposure, comparator, and concomitant treatment? Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: The manuscript records oral glyburide versus injected insulin. Only original study conditions are described; no administration/substitution instructions are created. - Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Dose, duration, switching/rescue treatment, adherence, common dietary/other care, and arm-specific differences are unverified. The original content review remains incomplete. - Reason for missing information: Dose, duration, switching/rescue treatment, adherence, common dietary/other care, and arm-specific differences are unverified. - Required materials and conditions: Oral glyburide, subcutaneous insulin, actual exposure, and concurrent care - Materials to obtain first: Arm-specific intervention, exposure, and concomitant-treatment/change records - Further research: Separate nominal assignment, actual exposure, and other causes. 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: Oral glyburide, subcutaneous insulin, actual exposure, and concurrent care. 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: Oral glyburide, subcutaneous insulin, actual exposure, and concurrent care. - 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 test adaptations are Chamgap design; M19 §19.2.2–19.2.4, M03 §3.2.3; Chamgap adaptation; M19 §19.2.2–19.2.4 design considerations; detailed confounding records are Chamgap design - Related sources: S01 ### N05 · Was INDAO designed to test superiority in harm? Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: INDAO is an open-label randomized noninferiority trial. The selected note records that the superiority-in-harm conclusion was not confirmed. - Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. A prespecified harm-superiority hypothesis and two-sided testing/multiplicity plan are unverified in this summary. The noninferiority design is not changed into the same superiority design. The original content review remains incomplete. - Reason for missing information: A prespecified harm-superiority hypothesis and two-sided testing/multiplicity plan are unverified in this summary. The noninferiority design is not changed into the same superiority design. - Required materials and conditions: Noninferiority/superiority hypotheses, prespecified tests, and analysis plan - Materials to obtain first: Hypothesis/testing plans in the protocol and SAP - Further research: Distinguish results for different statistical 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: Noninferiority/superiority hypotheses, prespecified tests, and analysis plan. 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: Noninferiority/superiority hypotheses, prespecified tests, and analysis plan. - 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; Chamgap adaptation; M08 Table 8.2.a, M04 §4.6.3; Chamgap adaptation; Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool - Related sources: S01 ### N06 · What were actual randomization, open-label procedures, and measurement operations? Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: The original description is open-label randomization of 914 participants (460/454) at 13 hospitals. - Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Allocation operations, baseline balance, event-adjudication blinding, and detection/testing differences are unverified. Harm causation is neither established nor denied solely from the open-label design. The original content review remains incomplete. - Reason for missing information: Allocation operations, baseline balance, event-adjudication blinding, and detection/testing differences are unverified. Harm causation is neither established nor denied solely from the open-label design. - Required materials and conditions: Allocation, concealment, baseline balance, event measurement, and blinding - Materials to obtain first: Allocation, measurement, and blinding-operation material - Further research: Link design to limitations of actual event measurement. 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: Allocation, concealment, baseline balance, event measurement, and blinding. 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: Allocation, concealment, baseline balance, event measurement, and blinding. - 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; Chamgap adaptation; M19 §19.1.2–19.2.4; detailed discrimination is Chamgap design; M19 §19.1.2–19.2.4, M04 §4.6.3; Chamgap adaptation - Related sources: S01 ### N07 · What are perinatal-composite event definitions and counting units? Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: INDAO’s primary composite is at least one of three components. Maternal hypoglycemia is not moved into this explicitly stated composite. - Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Event-specific criteria, overlap, maternal/neonatal linkage, assessment period, and collection methods are unverified. The original content review remains incomplete. - Reason for missing information: Event-specific criteria, overlap, maternal/neonatal linkage, assessment period, and collection methods are unverified. - Required materials and conditions: Macrosomia, neonatal hypoglycemia, hyperbilirubinemia, and overlap handling - Materials to obtain first: Composite/component definitions and event tables - Further research: Record composite person/event units and each harm 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: Macrosomia, neonatal hypoglycemia, hyperbilirubinemia, and overlap handling. 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: Macrosomia, neonatal hypoglycemia, hyperbilirubinemia, and overlap handling. - 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: M19 §19.1.2–19.2.4; detailed discrimination 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 - Related sources: S01 ### N08 · Are original event rates/difference interpreted directly as superiority in harm? Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: The original composite rates of 27.6% versus 23.4% and absolute difference of +4.2 percentage points are preserved. Observed direction and confirmation of significant superiority in harm do not mean the same thing. - Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Exact event counts, denominator correspondence, and superiority CI/P are unverified. No new difference, RR, OR, or significance is calculated. The original content review remains incomplete. - Reason for missing information: Exact event counts, denominator correspondence, and superiority CI/P are unverified. No new difference, RR, OR, or significance is calculated. - Required materials and conditions: Original rates, absolute difference, denominators, and testing framework - Materials to obtain first: Event/denominator result tables and superiority analysis - Further research: Separate observed direction from testing conclusions. 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 rates, absolute difference, denominators, and testing framework. 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 rates, absolute difference, denominators, and testing framework. - 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: M19 §19.2.2–19.2.4, M03 §3.2.3; Chamgap adaptation; M19 §19.1.2–19.2.4; Chamgap adaptation; Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool; M15 §15.3.1–15.3.3; Chamgap adaptation - Related sources: S01 ### N09 · Is the one-sided noninferiority interval a harm-superiority interval? Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: Supplied values are a one-sided 97.5% CI upper bound of +10.5 percentage points and noninferiority P=.19. - Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. The superiority two-sided interval/test P, lower bound, and actual prespecified plan are unverified. The upper bound is not used as a full CI, nor .19 as a harm-superiority P. The original content review remains incomplete. - Reason for missing information: The superiority two-sided interval/test P, lower bound, and actual prespecified plan are unverified. The upper bound is not used as a full CI, nor .19 as a harm-superiority P. - Required materials and conditions: Confidence level, one-sided upper bound, noninferiority P, and separate superiority statistics - Materials to obtain first: Prespecified superiority plan and corresponding original analysis table - Further research: Maintain the hypothesis and interval definition of the original statistics. 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: Confidence level, one-sided upper bound, noninferiority P, and separate superiority statistics. 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: Confidence level, one-sided upper bound, noninferiority P, and separate superiority statistics. - 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 interpretation boundary, informed by M19 principles, without running an official causality tool; M15 §15.3.1–15.3.3; Chamgap adaptation; M08 Table 8.2.a, M04 §4.6.3; Chamgap adaptation - Related sources: S01 ### N10 · How does failure at the +7-percentage-point threshold differ from significant harm? Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: The manuscript says the +10.5-percentage-point upper bound exceeded the prespecified +7-percentage-point margin, so being within the acceptable margin was not demonstrated. It explicitly states this was not proof of significantly worse outcomes. - Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. No new superiority threshold, zero effect, equivalence, or judgment of all safety outcomes is created. The original content review remains incomplete. - Reason for missing information: No new superiority threshold, zero effect, equivalence, or judgment of all safety outcomes is created. - Required materials and conditions: Distinction between the noninferiority margin and superiority conclusion - Materials to obtain first: Original noninferiority/superiority plans and conclusions - Further research: Separate the failed question from the distinct unconfirmed 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: Distinction between the noninferiority margin and superiority 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: Distinction between the noninferiority margin and superiority 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: Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool; 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 - Related sources: S01 ### N11 · Are assignment, PP, exposure, and neonatal denominators separated? Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: 914 randomized (460/454) and the prespecified PP 809 (367/442) are preserved separately. - Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Arm-specific exclusions/switching, actual exposure, and maternal/neonatal observation/event denominators are unverified. No new exclusion counts, rates, or risks are calculated. The original content review remains incomplete. - Reason for missing information: Arm-specific exclusions/switching, actual exposure, and maternal/neonatal observation/event denominators are unverified. No new exclusion counts, rates, or risks are calculated. - Required materials and conditions: Person/neonatal units and assignment/exposure/observation/analysis units - Materials to obtain first: Flow diagram, PP definition, and endpoint-specific denominator tables - Further research: Link exposed participants, people with events, and analysis units 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: Person/neonatal units and assignment/exposure/observation/analysis units. 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: Person/neonatal units and assignment/exposure/observation/analysis units. - 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, M19 §19.1.2–19.2.4; design-specific adaptations 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 ### N12 · Do other analysis populations confirm the superiority conclusion? Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: The manuscript records only that 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. Supplementary populations/results and superiority hypotheses/values are unverified. They are not filled as significant harm or ITT confirmation. The original content review remains incomplete. - Reason for missing information: Supplementary populations/results and superiority hypotheses/values are unverified. They are not filled as significant harm or ITT confirmation. - Required materials and conditions: Supplementary-analysis names, denominators, effects/CIs, and prespecified hypotheses - Materials to obtain first: Supplementary analyses/SAP and effect-of-interest material - Further research: Maintain PP, supplementary analyses, and harm superiority as distinct records. 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: Supplementary-analysis names, denominators, effects/CIs, and prespecified hypotheses. 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: Supplementary-analysis names, denominators, effects/CIs, and prespecified hypotheses. - 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, M15 §15.3.1; Chamgap adaptation; M19 §19.1.2–19.2.4, M04 §4.6.3; Chamgap adaptation; Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool - Related sources: S01 ### N13 · Are harm-observation timing, missed tests, and discontinuation known? Verification status: Unverified Reading scope: Summary read; external material unread - Current findings: Only the historical study context of the perinatal composite and medication assignment is available. - Why unverified: Currently required information in the stored summary is unverified. Exact exposure/latency/event timing, missed tests, spontaneous/systematic collection, discontinuation, and recovery information are unverified. The original content review remains incomplete. - Reason for missing information: Exact exposure/latency/event timing, missed tests, spontaneous/systematic collection, discontinuation, and recovery information are unverified. - Required materials and conditions: Exposure start/end, event timing, testing/follow-up, and discontinuation - Materials to obtain first: Event-collection, follow-up, and discontinuation records - Further research: Distinguish unreported/unverified information from absence of events. 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: Exposure start/end, event timing, testing/follow-up, and discontinuation. 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: Exposure start/end, event timing, testing/follow-up, and discontinuation. - 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: M19 §19.1.2–19.2.4; detailed discrimination is Chamgap design; M19 §19.2 design-specific harm questions; temporal-relationship details are Chamgap design; M19 §19.1.2–19.2.4, M04 §4.6.3; Chamgap adaptation - Related sources: S01 ### N14 · Were concurrent treatment and alternative explanations reviewed? Verification status: Unverified Reading scope: Summary read; external material unread - Current findings: The original descriptions of an open-label randomized comparison and medication requirement after dietary treatment are preserved. - Why unverified: Currently required information in the stored summary is unverified. Arm-specific baseline risk, concomitant/rescue treatment, adherence, changes, and harm-adjustment models are unverified. Absence of other causes is not asserted. The original content review remains incomplete. - Reason for missing information: Arm-specific baseline risk, concomitant/rescue treatment, adherence, changes, and harm-adjustment models are unverified. Absence of other causes is not asserted. - Required materials and conditions: Baseline risk, concomitant treatment, switching, confounding, and adjustment - Materials to obtain first: Baseline/concomitant treatment, actual exposure, and adjusted-analysis tables - Further research: Distinguish observed harm from causal attribution to a single medication. 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: Baseline risk, concomitant treatment, switching, confounding, and adjustment. 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: Baseline risk, concomitant treatment, switching, confounding, and adjustment. - 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: M19 §19.2.2–19.2.4 design considerations; detailed confounding records are Chamgap design; M03 §3.2.3, M08 §8.2.2–8.2.3; Chamgap adaptation - Related sources: S01 ### N15 · What is the actual reading level for registration and the superiority plan? Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: NCT01731431 is preserved as originally recorded. The number does not mean the superiority plan was read. - Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. External registration, protocol, and SAP remain unread; access was not attempted. Nonregistration or selective reporting is not newly established. The original content review remains incomplete. - Reason for missing information: External registration, protocol, and SAP remain unread; access was not attempted. Nonregistration or selective reporting is not newly established. - Required materials and conditions: NCT identifier, hypotheses, change history, and protocol/SAP - Materials to obtain first: Registration history, protocol, and SAP - Further research: If corresponding material is supplied, record differences among hypotheses, changes, and reporting. 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: NCT identifier, hypotheses, change history, and protocol/SAP. 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: NCT identifier, hypotheses, change history, and protocol/SAP. - 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; separation of access/reading and the hyperlink contract are Chamgap design; M08 Table 8.2.a, M04 §4.6.3; Chamgap adaptation; Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool - Related sources: S01 ### N16 · What verification scope applies to public funding and unreported commercial support? Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: The original description of French Ministry of Health PHRC and AP-HP public sponsor support, and unreported commercial pharmaceutical funding/free study medication, is preserved. - Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Contracts, actual absence, employee authors, patents, analysis/writing/publication support, and individual COI are unverified. No new independence certification is made. The original content review remains incomplete. - Reason for missing information: Contracts, actual absence, employee authors, patents, analysis/writing/publication support, and individual COI are unverified. No new independence certification is made. - Required materials and conditions: PHRC/AP-HP, commercial support, medication, authors/COI, and roles - Materials to obtain first: Original funding, product, author/COI, and role material - Further research: Distinguish disclosed information from 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: PHRC/AP-HP, commercial support, medication, authors/COI, 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/AP-HP, commercial support, medication, authors/COI, 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 · Is INDAO maternal hypoglycemia evidence of composite superiority? Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: The manuscript describes more frequent maternal hypoglycemia in the glyburide arm. It is not transferred to 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 values, CI/P, severity, timing, and denominators are unverified. “More frequent” is not upgraded to verified significance. The original content review remains incomplete. - Reason for missing information: Arm-specific values, CI/P, severity, timing, and denominators are unverified. “More frequent” is not upgraded to verified significance. - Required materials and conditions: Maternal-event definition, arm-specific values, denominators, and harm analysis - Materials to obtain first: Maternal hypoglycemia result table and analysis plan - Further research: Attribute maternal harms and the neonatal composite 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-event definition, arm-specific values, denominators, and harm analysis. 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-event definition, arm-specific values, denominators, and harm analysis. - 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: M19 §19.1.2–19.2.4; detailed discrimination is Chamgap design; M19 §19.2.2–19.2.4, M03 §3.2.3; Chamgap adaptation; 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: S01 ### N18 · Are INDAO’s individual neonatal-component results known? Verification status: Unverified Reading scope: Summary read; external material unread - Current findings: The pivotal report supplies composite results for three components. - Why unverified: Currently required information in the stored summary is unverified. Counts, rates, CI/P, multiplicity, and denominators for each INDAO component are unverified in this summary. Composite rates are not repurposed as individual-harm rates. The original content review remains incomplete. - Reason for missing information: Counts, rates, CI/P, multiplicity, and denominators for each INDAO component are unverified in this summary. Composite rates are not repurposed as individual-harm rates. - Required materials and conditions: Individual events/CIs for macrosomia, hypoglycemia, and hyperbilirubinemia - Materials to obtain first: Component results, definitions, and testing plan - Further research: Separate comparison conclusions for the composite and each component. 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 events/CIs 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 events/CIs for macrosomia, hypoglycemia, and hyperbilirubinemia. - 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: M19 §19.1.2–19.2.4; detailed discrimination is Chamgap design; M19 §19.2.2–19.2.4, M03 §3.2.3; Chamgap adaptation; 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: S01 ### N19 · How are Helal’s overall synthesis and RCT subgroup analysis distinguished? Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: The review records 24 studies with 24,517 participants overall and an 11-RCT subgroup. - Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. RCT subgroup participant counts, endpoint-specific samples, and original-trial inclusion/overlap are unverified. The overall total is not used as the RCT denominator or summed with INDAO/Langer/sibling sheets. The original content review remains incomplete. - Reason for missing information: RCT subgroup participant counts, endpoint-specific samples, and original-trial inclusion/overlap are unverified. The overall total is not used as the RCT denominator or summed with INDAO/Langer/sibling sheets. - Required materials and conditions: 24 studies/24,517 participants overall, 11 RCTs, and endpoint-specific denominators - Materials to obtain first: Included-trial and design/endpoint-specific analysis tables - Further research: Separate synthesis reports from actual original-trial/population units. 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: 24 studies/24,517 participants overall, 11 RCTs, 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: 24 studies/24,517 participants overall, 11 RCTs, 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: M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linking is Chamgap adaptation; M19 §19.1.2–19.2.4; Chamgap adaptation; M04 §4.6.1–4.6.2; harm-material adaptations are Chamgap design - Related sources: S02 ### N20 · What are the review’s RCT maternal hypoglycemia/LGA results? Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: S02’s evidence/citation entries record more maternal hypoglycemia and LGA in the RCT subgroup. - Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Subgroup quantitative values, CI/P, endpoint-specific denominators, and heterogeneity are unverified. They are not repurposed as significant-harm values for the INDAO composite. The original content review remains incomplete. - Reason for missing information: Subgroup quantitative values, CI/P, endpoint-specific denominators, and heterogeneity are unverified. They are not repurposed as significant-harm values for the INDAO composite. - Required materials and conditions: Subgroup endpoints, effects/intervals, arms/denominators, and definitions - Materials to obtain first: Original endpoint-specific RCT subgroup analysis tables - Further research: Attribute results individually by analysis level, event, and 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: Subgroup endpoints, effects/intervals, arms/denominators, and definitions. 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: Subgroup endpoints, effects/intervals, arms/denominators, and definitions. - 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: M19 §19.1.2–19.2.4; detailed discrimination is Chamgap design; M19 §19.2.2–19.2.4, M03 §3.2.3; Chamgap adaptation; M19 §19.1.2–19.2.4; Chamgap adaptation; M04 §4.6.1–4.6.2; harm-material adaptations are Chamgap design; Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool - Related sources: S02 ### N21 · Which result does the overall pooled neonatal hypoglycemia OR describe? Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: S02’s evidence entry supplies 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. Composition of the mixed designs, event definitions, adjustment, and endpoint-specific denominators/heterogeneity are unverified. This is not changed into an 11-RCT-only result, INDAO value, or superiority across all harms. The original content review remains incomplete. - Reason for missing information: Composition of the mixed designs, event definitions, adjustment, and endpoint-specific denominators/heterogeneity are unverified. This is not changed into an 11-RCT-only result, INDAO value, or superiority across all harms. - Required materials and conditions: Overall pooling, neonatal events, OR/CI, and original analysis scope - Materials to obtain first: Endpoint/design-specific result tables for the overall pooling - Further research: Link the original OR/interval only to its corresponding overall analysis. 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: Overall pooling, neonatal events, OR/CI, and original analysis 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: Overall pooling, neonatal events, OR/CI, and original analysis 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: M19 §19.2.2–19.2.4, M03 §3.2.3; Chamgap adaptation; M19 §19.1.2–19.2.4; Chamgap adaptation; M19 §19.2.2–19.2.4 design considerations; detailed confounding records are Chamgap design; Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool; M15 §15.3.1–15.3.3; Chamgap adaptation - Related sources: S02 ### N22 · What is the difference between stored-summary descriptions of the review’s analysis levels? Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: The Korean/English safety explanation records increased neonatal hypoglycemia and LGA in the RCT subgroup. The evidence list distinguishes RCT maternal hypoglycemia/LGA from the overall neonatal hypoglycemia OR. - Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Each original wording is preserved while the original paper remains unread. No new judgment about which wording is correct or arbitrary reassignment of the endpoint is made. The original content review remains incomplete. - Reason for missing information: Each original wording is preserved while the original paper remains unread. No new judgment about which wording is correct or arbitrary reassignment of the endpoint is made. - Required materials and conditions: Outcome attribution in evidence/safety explanations and external-verification scope - Materials to obtain first: Endpoint-specific overall/RCT tables in the original review - Further research: If the original paper is supplied, record explanations/correction events for the wording difference 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: Outcome attribution in evidence/safety explanations and external-verification 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: Outcome attribution in evidence/safety explanations and external-verification 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: M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is Chamgap design; Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool; M04 §4.5, §4.6.3; limitations of the current material conversion follow the review scope and Chamgap design - Related sources: S02 ### N23 · What information do Helal’s support and registration entries actually provide? Verification status: Unverified Reading scope: Summary read; external material unread - Current findings: The funding entry is “systematic review; included-trial funding mixed”, and nct is “not applicable”. The actual registration identifier remains null. - Why unverified: Currently required information in the stored summary is unverified. The review’s own funding, COI, plans, and relationships for each included trial are unverified. “Not applicable” and mixed support are not used as independence/absence certification. The original content review remains incomplete. - Reason for missing information: The review’s own funding, COI, plans, and relationships for each included trial are unverified. “Not applicable” and mixed support are not used as independence/absence certification. - Required materials and conditions: Review/included-trial funding, COI, plans, and registration - Materials to obtain first: Review plan, disclosures, and included-trial support table - Further research: Separate material types, review roles, and original-trial support. 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: Review/included-trial funding, COI, plans, and registration. 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: Review/included-trial funding, COI, plans, and registration. - 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; M04 §4.5–4.6 material-collection/selection principles; separation of access/reading and the hyperlink contract are Chamgap design; M04 §4.6.1–4.6.2; harm-material adaptations are Chamgap design - Related sources: S02 ### N24 · What were the earlier Langer trial’s opposing results? Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: The 404-participant RCT had primary glycemic control and secondary individual perinatal outcomes. LGA 12/13%, neonatal hypoglycemia 9/6%, no significant difference, 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. Arm-specific denominators, CI/P, definitions, and period are unverified. Nonsignificance is not changed into zero harm, equivalence, or INDAO noninferiority success. The original content review remains incomplete. - Reason for missing information: Arm-specific denominators, CI/P, definitions, and period are unverified. Nonsignificance is not changed into zero harm, equivalence, or INDAO noninferiority success. - Required materials and conditions: Primary/secondary endpoints, individual complications, nonsignificance, and original conclusion - Materials to obtain first: Langer plan and individual-event result tables - Further research: Record opposing results together with limitations from different questions/designs. 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: Primary/secondary endpoints, individual complications, nonsignificance, and 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: Primary/secondary endpoints, individual complications, nonsignificance, and 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; separation of statuses is Chamgap design; M19 §19.2.2–19.2.4, M03 §3.2.3; Chamgap adaptation; M19 §19.1.2–19.2.4; Chamgap adaptation; M04 §4.6.1–4.6.2; harm-material adaptations are Chamgap design; Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool - Related sources: S03 ### N25 · What level do Langer’s funding/registration wordings represent? Verification status: Unverified Reading scope: Summary read; external material unread - Current findings: Funding “reported in the original paper” and nct “not applicable” are preserved as originally recorded. These wordings are not an actual funding provider or registration number. - Why unverified: Currently required information in the stored summary is unverified. External original paper/plans and support, product, and author/COI details are unverified. Absence is not newly established. The original content review remains incomplete. - Reason for missing information: External original paper/plans and support, product, and author/COI details are unverified. Absence is not newly established. - Required materials and conditions: Actual supporter, product/COI, registration, and plans - Materials to obtain first: Original plan, support, and COI material - Further research: Distinguish original wording from newly supplied actual identity 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: Actual supporter, product/COI, registration, and plans. 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: Actual supporter, product/COI, registration, and plans. - 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 independence/attribution conditions. The referenced official method sections do not certify every detail of these items; Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design - Related sources: S03 ### N26 · Are the same events, trials, and review counted as independent replications? Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: INDAO, the Helal review, and Langer are linked as separate report slots and shared with the sibling noninferiority sheet. - Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Review inclusion, identical/subsequent reports, and event overlaps were not checked. Report counts, original R1, or participants are not certified as new independent harm replications/unique totals. The original content review remains incomplete. - Reason for missing information: Review inclusion, identical/subsequent reports, and event overlaps were not checked. Report counts, original R1, or participants are not certified as new independent harm replications/unique totals. - Required materials and conditions: Report-to-trial-to-event links, recitation, and review-inclusion relationships - Materials to obtain first: Related/included-trial and event-linking tables - Further research: Maintain relationships among original trials, review recitations, and the same people/timepoints. 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: Report-to-trial-to-event links, recitation, and review-inclusion relationships. 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: Report-to-trial-to-event links, recitation, and review-inclusion relationships. - 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 distinction between studies and reports; cohort/outcome linking is Chamgap adaptation; M04 §4.6.1–4.6.2; harm-material adaptations are Chamgap design - Related sources: S01, S02, S03 ### N27 · Does the current record establish comparison direction, a signal, or causality? Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: INDAO’s failure to demonstrate noninferiority/unconfirmed superiority are distinguished from individual maternal/neonatal harm contexts. Selected D is the original-data verdict, not a new harm grade. - Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. No new conclusions about all harms, all medications, individual causality, an exactly zero effect, or confirmed superiority are created. The original content review remains incomplete. - Reason for missing information: No new conclusions about all harms, all medications, individual causality, an exactly zero effect, or confirmed superiority are created. - Required materials and conditions: Design, intervals, alternatives, and original-conclusion scope of each material - Materials to obtain first: Original hypothesis/interval and event-specific conclusions, plus alternative material - Further research: Maintain each original report’s comparison/interpretation scope 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: Design, intervals, alternatives, and original-conclusion scope of 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: Design, intervals, alternatives, and original-conclusion scope of 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: Chamgap’s own interpretation boundary, informed by M19 principles, without running an official causality tool; M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is Chamgap design - Related sources: S01, S02, S03 ### N28 · Is the result extended to other drugs, vulnerable groups, or long-term harms? Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: The manuscript records that sulfonylurea placental-transfer characteristics vary by drug and are not generalized to the whole class. - Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. Direct material for other drugs, pregnancy populations/timing, and long-term offspring/rare harms is unverified. No instructions to implement medication selection/substitution/administration or monitoring are created. The original content review remains incomplete. - Reason for missing information: Direct material for other drugs, pregnancy populations/timing, and long-term offspring/rare harms is unverified. No instructions to implement medication selection/substitution/administration or monitoring are created. - Required materials and conditions: Direct material on drug classes, pregnancy timing, long-term/rare harms, and baseline risk - Materials to obtain first: Separate medication/population and long-term-harm material - Further research: Separate the narrow comparative-harm question from questions outside its scope. 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: Direct material on drug classes, pregnancy timing, long-term/rare harms, and baseline risk. 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: Direct material on drug classes, pregnancy timing, long-term/rare harms, and baseline risk. - 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: 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: S01, S02, S03 ### N29 · What historical context do parent values, languages, empty values, dates, and corrections provide? Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: Parent C54, unrecorded precision, false values, empty override reasons, Korean/English manuscripts, 2026-08-26, empty correction/deliberation values, historical cross-checking, and selected D/note 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. Parent values are not filled into subclaim scores/axes. This does not mean a current search, correction/retraction check, or completed content review. The original content review remains incomplete. - Reason for missing information: Parent values are not filled into subclaim scores/axes. This does not mean a current search, correction/retraction check, or completed content review. - Required materials and conditions: Preservation of C54, original axes/safety, Korean/English text, and historical verdict/corrections - Materials to obtain first: Correction records, user comments, and supplied original material - Further research: Distinguish the original record from production and amendment 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: Preservation of C54, original axes/safety, Korean/English text, and historical verdict/corrections. 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: Preservation of C54, original axes/safety, Korean/English text, and historical verdict/corrections. - 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 ### N30 · Are actual summary reading and unread external material distinguished? Verification status: Partly verified Reading scope: Summary read; external material unread - Current findings: The full JSON with three evidence entries and three citations was read for production, and original links are preserved. Summaries are labeled “summary read”; external material is labeled “unread”. - Why unverified: Only the corresponding stored-summary information is recorded; detailed original material remains unread and the original content review incomplete. External abstracts/full texts, registration, plans, and disclosures remain unread; access was not attempted. A link’s existence is not changed into acquisition, original-paper review, or successful access. The original content review remains incomplete. - Reason for missing information: External abstracts/full texts, registration, plans, and disclosures remain unread; access was not attempted. A link’s existence is not changed into acquisition, original-paper review, or successful access. - Required materials and conditions: Access status for preserved material, papers, registration, protocol, SAP, and disclosures - Materials to obtain first: Each material and actual reading record - Further research: Update each material’s existence, acquisition, and reading level 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: Access status for preserved material, papers, registration, protocol, SAP, and disclosures. 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: Access status for preserved material, papers, registration, protocol, SAP, and disclosures. - 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: The original note that INDAO did not confirm the superiority conclusion of significantly greater harm is preserved. 27.6% versus 23.4%, difference +4.2 percentage points, one-sided 97.5% CI upper bound +10.5 percentage points, and noninferiority P=0.19 are noninferiority results; that CI upper bound/P is not repurposed as a superiority interval/test. Observed composite direction, maternal-hypoglycemia descriptions, and superiority confirmation are distinct. 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. The public page and data were prepared from the existing 30 items. No new clinical search, verification-status change or scoring was performed.