Full dated editorial ledger. Review depth and source access vary by record; these notes are not independent clinical certification. 82 records appear in this report.
Baseline trial evidence review: A–H
Review date: 16 September 2026. Reviewer: GPT-Astra (medium), assisting GPT-Astra (xhigh). This is an AI editorial/source audit, not clinical validation.
Scope: 82 baseline records. Excludes parent-reserved ASK, ELSA, covalent-112, pediatric BCG and BETA-PRESERVE records, and newly added records. All summaries, endpoints and eligibility fields in this set were read against the cached primary registry protocol where available. Historical result narratives were checked against accessible primary abstracts or full reports as described below.
Sources and limits: ClinicalTrials.gov API records were retrieved for this refresh. Europe PMC supplies PubMed-indexed primary abstracts; it is an access route, not an additional independent study. Publisher full reports were accessible for CREATE, AiDAPT and Fr1da. ANZCTR was consulted directly for ASITI-201. Abstract-only checks cannot verify every subgroup, adverse-event table, device configuration or supplementary analysis. No-result registry records do not prove that no publication exists. Sponsor-only interim results remain lower-certainty and were not upgraded to peer-reviewed evidence. registryChecked and lastReviewed retain distinct meanings; this ledger does not certify every linked citation or redate untouched records.
Principal corrections include ADAPT model-based contrasts, BANDIT’s false first-oral-treatment claim, DPT-1’s exploratory subgroup, CREATE’s New Zealand location and device phase, FLAIR’s age bounds and missing citations, AiDAPT’s pregnancy target and adverse events, and Fr1da’s observational interpretation.
abatacept-prevention-at-risk
Outcome: No new discrepancy identified in the reviewed summary, stated design, primary endpoint and eligibility against the available registry. This is a bounded protocol comparison, not confirmation of efficacy.
Registry: NCT01773707. Registered endpoint checked: Time From Randomization to Confirmed Abnormal Glucose Tolerance Test (96 months). Eligibility check: Registry age 6 Years to 45 Years; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Accessible primary literature: Abatacept for Delay of Type 1 Diabetes Progression in Stage 1 Relatives at Risk: A Randomized, Double-Masked, Controlled Trial.. Limits: Primary abstract findings were available; supplementary tables and full adverse-event adjudication were not comprehensively re-reviewed. Registry eligibility is not a claim of current site availability.
abatacept-rituximab-combo
Outcome: No new discrepancy identified in the reviewed summary, stated design, primary endpoint and eligibility against the available registry. This is a bounded protocol comparison, not confirmation of efficacy.
Registry: NCT03929601. Registered endpoint checked: C-Peptide Response to 2-hr MMTT at 24 months post-randomization (48-months from Day 0). Eligibility check: Registry age 8 Years to 45 Years; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Accessible primary literature: Rituximab, B-lymphocyte depletion, and preservation of beta-cell function.; Co-stimulation modulation with abatacept in patients with recent-onset type 1 diabetes: a randomised, double-blind, placebo-controlled trial.. Limits: Primary abstract findings were available; supplementary tables and full adverse-event adjudication were not comprehensively re-reviewed. Registry eligibility is not a claim of current site availability.
abatacept-tn09-newonset
Outcome: No new discrepancy identified in the reviewed summary, stated design, primary endpoint and eligibility against the available registry. This is a bounded protocol comparison, not confirmation of efficacy.
Registry: NCT00505375. Registered endpoint checked: Area Under the Stimulated C-peptide Curve Over the First 2 Hours of a 4 Hour Mixed Meal Tolerance Test at the 2 Year Visit (2 years of follow up). Eligibility check: Registry age 6 Years to 45 Years; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Accessible primary literature: CTLA4-Ig (abatacept): a promising investigational drug for use in type 1 diabetes.. Limits: Primary abstract findings were available; supplementary tables and full adverse-event adjudication were not comprehensively re-reviewed. Registry eligibility is not a claim of current site availability.
abbott-dual-glucose-ketone-dka
Outcome: No new discrepancy identified in the reviewed summary, stated design, primary endpoint and eligibility against the available registry. This is a bounded protocol comparison, not confirmation of efficacy.
Registry: NCT07739342. Registered endpoint checked: Primary Objective (12 months). Eligibility check: Registry age 2 Years to not specified; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Limits: No usable primary abstract was independently recovered in this pass for this record. Protocol/design wording was assessed; any existing detailed sponsor, conference or historical outcome claims require their cited source and were not independently certified through full-text review.
access-t1d-florida-screening
Outcome: No new discrepancy identified in the reviewed summary, stated design, primary endpoint and eligibility against the available registry. This is a bounded protocol comparison, not confirmation of efficacy.
Registry: NCT06908057. Registered endpoint checked: Blood sample will be drawn for islet-related autoantibodies (Visit 1 (1 day, 1-2 hours)- Only visit for the entire study.). Eligibility check: Registry age 2 Years to not specified; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Limits: No usable primary abstract was independently recovered in this pass for this record. Protocol/design wording was assessed; any existing detailed sponsor, conference or historical outcome claims require their cited source and were not independently certified through full-text review.
adapt-minimed-780g
Outcome: Clarified group means versus reported changes and adjusted contrast; restricted primary endpoint to main six-month study; removed stigmatizing wording. Abstract itself contains the numerically inconsistent group means/change values; did not invent a correction.
Registry: NCT04235504. Registered endpoint checked: HbA1c 6 Months Change Between AHCL and MDI (Baseline and end of 6-month study phase). Eligibility check: Registry age 18 Years to not specified; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Accessible primary literature: Twelve-month results of the ADAPT randomized controlled trial: Reproducibility and sustainability of advanced hybrid closed-loop therapy outcomes versus conventional therapy in adults with type 1 diabetes.; Advanced hybrid closed loop therapy versus conventional treatment in adults with type 1 diabetes (ADAPT): a randomised controlled study.; Advanced hybrid closed loop therapy versus conventional treatment in adults with type 1 diabetes (ADAPT): a randomised controlled study.. Limits: Primary abstract findings were available; supplementary tables and full adverse-event adjudication were not comprehensively re-reviewed. Registry eligibility is not a claim of current site availability.
ai-assisted-remote-pump-optimization
Outcome: No new discrepancy identified in the reviewed summary, stated design, primary endpoint and eligibility against the available registry. This is a bounded protocol comparison, not confirmation of efficacy.
Registry: NCT07732777. Registered endpoint checked: Time-in-Range (TIR) (the last 2 weeks of each 4-week intervention period). Eligibility check: Registry age 14 Years to 65 Years; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Limits: No usable primary abstract was independently recovered in this pass for this record. Protocol/design wording was assessed; any existing detailed sponsor, conference or historical outcome claims require their cited source and were not independently certified through full-text review.
aid-before-during-pregnancy
Outcome: Expanded sparse summary/eligibility using current registry design, inclusion criteria and primary outcome; no efficacy inferred from registration.
Registry: NCT07240012. Registered endpoint checked: Time in range (From first day of last menstrual cycle (planning pregnancy) or randomization (early pregnancy) until delivery.); Neonatal outcome: Birthweight (At delivery). Eligibility check: Registry age 18 Years to 45 Years; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Limits: No usable primary abstract was independently recovered in this pass for this record. Protocol/design wording was assessed; any existing detailed sponsor, conference or historical outcome claims require their cited source and were not independently certified through full-text review.
aid-beyond-glucose-metrics
Outcome: Expanded sparse summary/eligibility using current registry design, inclusion criteria and primary outcome; no efficacy inferred from registration.
Registry: NCT06469593. Registered endpoint checked: Difference in change from baseline to study end in sleep efficiency between the two groups. (Baseline and week 18). Eligibility check: Registry age 7 Years to not specified; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Limits: No usable primary abstract was independently recovered in this pass for this record. Protocol/design wording was assessed; any existing detailed sponsor, conference or historical outcome claims require their cited source and were not independently certified through full-text review.
aidanet-ai-bolus-priming
Outcome: Expanded sparse summary/eligibility using current registry design, inclusion criteria and primary outcome; no efficacy inferred from registration.
Registry: NCT07517770. Registered endpoint checked: Time in Range (TIR) 70-180 mg/dL for 2-week free-living at home periods on AIDANET vs AIDANET AI. (two weeks). Eligibility check: Registry age 18 Years to not specified; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Limits: No usable primary abstract was independently recovered in this pass for this record. Protocol/design wording was assessed; any existing detailed sponsor, conference or historical outcome claims require their cited source and were not independently certified through full-text review.
aidanet-at-home
Outcome: No new discrepancy identified in the reviewed summary, stated design, primary endpoint and eligibility against the available registry. This is a bounded protocol comparison, not confirmation of efficacy.
Registry: NCT07039617. Registered endpoint checked: Time in Range (70-180 mg/dL) (16 weeks). Eligibility check: Registry age 18 Years to not specified; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Limits: No usable primary abstract was independently recovered in this pass for this record. Protocol/design wording was assessed; any existing detailed sponsor, conference or historical outcome claims require their cited source and were not independently certified through full-text review.
aidanet-fcl-home
Outcome: No new discrepancy identified in the reviewed summary, stated design, primary endpoint and eligibility against the available registry. This is a bounded protocol comparison, not confirmation of efficacy.
Registry: NCT06041971. Registered endpoint checked: Mean Sensor Glucose Value (Change between second week of the control period and the one-week at home period). Eligibility check: Registry age 14 Years to 60 Years; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Limits: No usable primary abstract was independently recovered in this pass for this record. Protocol/design wording was assessed; any existing detailed sponsor, conference or historical outcome claims require their cited source and were not independently certified through full-text review.
aidapt-closed-loop-pregnancy
Outcome: Removed false first randomized pregnancy-trial claim; used FDA primary clearance; distinguished adjusted contrast and postpartum wider target/n57; added acute events from updated NEJM paper.
Registry: NCT04938557. Registered endpoint checked: The time spent with glucose levels between 3.5-7.8 mmol/L based on CGM measures (Time In Range TIR 3.5-7.8mmol/L) (Between 16 weeks gestation and delivery - an average of 18 weeks). Eligibility check: Registry age 18 Years to 45 Years; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Accessible primary literature: Automated insulin delivery during the first 6 months postpartum (AiDAPT): a prespecified extension study.; Automated Insulin Delivery in Women with Pregnancy Complicated by Type 1 Diabetes.. Limits: Primary abstract findings were available; supplementary tables and full adverse-event adjudication were not comprehensively re-reviewed. Registry eligibility is not a claim of current site availability. Full-report addition: Updated NEJM main paper reports six severe hypoglycemia events in closed loop versus five with standard care, and one DKA event in each arm. The postpartum extension uses the broader 70–180 mg/dL target and 57 participants; it is not the pregnancy endpoint.
aiming-intrapartum-aid
Outcome: No new discrepancy identified in the reviewed summary, stated design, primary endpoint and eligibility against the available registry. This is a bounded protocol comparison, not confirmation of efficacy.
Registry: NCT06883344. Registered endpoint checked: First neonatal glucose value (Within 2 hours of birth). Eligibility check: Registry age 18 Years to 55 Years; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Limits: No usable primary abstract was independently recovered in this pass for this record. Protocol/design wording was assessed; any existing detailed sponsor, conference or historical outcome claims require their cited source and were not independently certified through full-text review.
align-teplizumab-realworld
Outcome: No new discrepancy identified in the reviewed summary, stated design, primary endpoint and eligibility against the available registry. This is a bounded protocol comparison, not confirmation of efficacy.
Registry: NCT07360080. Registered endpoint checked: Time from teplizumab infusion start to the onset of Stage 3 T1D (From start of infusion to maximum of 10 years). Eligibility check: Registry age not specified to not specified; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Limits: No usable primary abstract was independently recovered in this pass for this record. Protocol/design wording was assessed; any existing detailed sponsor, conference or historical outcome claims require their cited source and were not independently certified through full-text review.
allogeneic-cd7-car-t-t1d
Outcome: No new discrepancy identified in the reviewed summary, stated design, primary endpoint and eligibility against the available registry. This is a bounded protocol comparison, not confirmation of efficacy.
Registry: NCT07528105. Registered endpoint checked: Safety: Incidence of dose-limiting toxicities (DLTs), adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) in participants with type 1 diabetes mellitus treated with RD13-02. (From the date of signing informed consent to 3 months after CAR-T cell infusion.); Change from baseline in 4-hour MMTT C-peptide AUC at Months 3, 6, and 12. (From baseline to Month 12.). Eligibility check: Registry age 18 Years to 40 Years; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Limits: No usable primary abstract was independently recovered in this pass for this record. Protocol/design wording was assessed; any existing detailed sponsor, conference or historical outcome claims require their cited source and were not independently certified through full-text review.
allogeneic-regenerative-islet-transplant
Outcome: Expanded sparse summary/eligibility using current registry design, inclusion criteria and primary outcome; no efficacy inferred from registration.
Registry: NCT06196996. Registered endpoint checked: Time in Range (up to 12 months); HbA1c (up to 12 months); C-peptide (up to 12 months); insulin (up to 12 months). Eligibility check: Registry age 6 Years to 65 Years; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Limits: No usable primary abstract was independently recovered in this pass for this record. Protocol/design wording was assessed; any existing detailed sponsor, conference or historical outcome claims require their cited source and were not independently certified through full-text review.
allogenic-islet-transplant-chicago
Outcome: Expanded sparse summary/eligibility using current registry design, inclusion criteria and primary outcome; no efficacy inferred from registration.
Registry: NCT00160732. Registered endpoint checked: decrease in insulin requirement - Subjects able to maintain fasting blood glucose concentrations below 126 mg/dL and 2-hour post prandial levels below 180 mg/dL will be considered to be insulin independent. (Monthly); decrease in incidence of hypoglycemic events (Monthly). Eligibility check: Registry age 18 Years to 58 Years; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Limits: No usable primary abstract was independently recovered in this pass for this record. Protocol/design wording was assessed; any existing detailed sponsor, conference or historical outcome claims require their cited source and were not independently certified through full-text review.
argus-2-cgm-adoption
Outcome: Expanded sparse summary/eligibility using current registry design, inclusion criteria and primary outcome; no efficacy inferred from registration.
Registry: NCT07425236. Registered endpoint checked: Quantity of Paired Argus and Reference Laboratory Blood Glucose Measurements During In-Clinic Visit (Day 1 (approximately 6 hours)); Quantity of Paired Argus and Dexcom Stelo CGM Data Points During Home-Wear Period (Day 1 through Day 15 (15 days)). Eligibility check: Registry age 18 Years to 75 Years; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Limits: No usable primary abstract was independently recovered in this pass for this record. Protocol/design wording was assessed; any existing detailed sponsor, conference or historical outcome claims require their cited source and were not independently certified through full-text review.
asiti-201-phase1
Outcome: No new discrepancy identified in the reviewed summary, stated design, primary endpoint and eligibility against the available registry. This is a bounded protocol comparison, not confirmation of efficacy.
Registry: ACTRN12624001043527. Primary registry detail: ANZCTR reports Phase 1, target 36, accrual 27, Part A complete and Part B recruiting; age 18–55, diagnosis within five years, specified HLA and residual C-peptide requirements. No efficacy result established.
autologous-tregs-t1d-nanjing
Outcome: No new discrepancy identified in the reviewed summary, stated design, primary endpoint and eligibility against the available registry. This is a bounded protocol comparison, not confirmation of efficacy.
Registry: NCT06708780. Registered endpoint checked: Number of Participants with adverse events, laboratory abnormalities and other signs of toxicity. (From enrollment to the end of treatment at 1 year). Eligibility check: Registry age 8 Years to 65 Years; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Limits: No usable primary abstract was independently recovered in this pass for this record. Protocol/design wording was assessed; any existing detailed sponsor, conference or historical outcome claims require their cited source and were not independently certified through full-text review.
bandit-baricitinib
Outcome: Removed incorrect first-oral-immunotherapy claim; BANDIT numeric outcomes and cohort checked against NEJM abstract; added earlier imatinib primary study.
Registry: NCT04774224. Registered endpoint checked: The primary endpoint of the study is the change from baseline of plasma C-peptide area under the curve (AUC) over 2 hours following a mixed meal. (Measured at 48 weeks post commencement of intervention.). Eligibility check: Registry age 10 Years to 30 Years; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Accessible primary literature: β-Cell Function Derived From Routine Clinical Measures Reports and Predicts Treatment Response to Immunotherapy in Recent-Onset Type 1 Diabetes.; Baricitinib and β-Cell Function in Patients with New-Onset Type 1 Diabetes.; Investigating the efficacy of baricitinib in new onset type 1 diabetes mellitus (BANDIT)-study protocol for a phase 2, randomized, placebo controlled trial.. Limits: Primary abstract findings were available; supplementary tables and full adverse-event adjudication were not comprehensively re-reviewed. Registry eligibility is not a claim of current site availability.
baricade-delay-baricitinib
Outcome: Expanded sparse summary/eligibility using current registry design, inclusion criteria and primary outcome; no efficacy inferred from registration.
Registry: NCT07222137. Registered endpoint checked: Time from Baseline to Diagnosis of Stage 3 Type 1 Diabetes (Baseline up to approximately 5 years). Eligibility check: Registry age 1 Year to 35 Years; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Limits: No usable primary abstract was independently recovered in this pass for this record. Protocol/design wording was assessed; any existing detailed sponsor, conference or historical outcome claims require their cited source and were not independently certified through full-text review.
baricade-preserve-baricitinib
Outcome: Expanded sparse summary/eligibility using current registry design, inclusion criteria and primary outcome; no efficacy inferred from registration.
Registry: NCT07222332. Registered endpoint checked: Change from Baseline in C-peptide Area Under the Curve (AUC) (Baseline, Week 52). Eligibility check: Registry age 1 Year to 35 Years; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Limits: No usable primary abstract was independently recovered in this pass for this record. Protocol/design wording was assessed; any existing detailed sponsor, conference or historical outcome claims require their cited source and were not independently certified through full-text review.
bcg-established-t1d
Outcome: No new discrepancy identified in the reviewed summary, stated design, primary endpoint and eligibility against the available registry. This is a bounded protocol comparison, not confirmation of efficacy.
Registry: NCT02081326. Registered endpoint checked: Change in HbA1c values in juvenile onset type 1 diabetics (1, 2, 3, 4, and 5 years after initial BCG/placebo injection). Eligibility check: Registry age 18 Years to 65 Years; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Limits: No usable primary abstract was independently recovered in this pass for this record. Protocol/design wording was assessed; any existing detailed sponsor, conference or historical outcome claims require their cited source and were not independently certified through full-text review.
cadisegliatin-hcl-adjunct
Outcome: No new discrepancy identified in the reviewed summary, stated design, primary endpoint and eligibility against the available registry. This is a bounded protocol comparison, not confirmation of efficacy.
Registry: NCT07616206. Registered endpoint checked: To assess the change in Time in Range (TIR) (last 2 weeks of the two 6-week treatment periods). Eligibility check: Registry age 18 Years to not specified; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Limits: No usable primary abstract was independently recovered in this pass for this record. Protocol/design wording was assessed; any existing detailed sponsor, conference or historical outcome claims require their cited source and were not independently certified through full-text review.
cadisegliatin-phase3-adjunct
Outcome: No new discrepancy identified in the reviewed summary, stated design, primary endpoint and eligibility against the available registry. This is a bounded protocol comparison, not confirmation of efficacy.
Registry: NCT06334133. Registered endpoint checked: Change in incidence of Level 2 or Level 3 hypoglycemia (26 weeks). Eligibility check: Registry age 18 Years to not specified; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Limits: No usable primary abstract was independently recovered in this pass for this record. Protocol/design wording was assessed; any existing detailed sponsor, conference or historical outcome claims require their cited source and were not independently certified through full-text review.
camaps-fx-very-young-children
Outcome: No new discrepancy identified in the reviewed summary, stated design, primary endpoint and eligibility against the available registry. This is a bounded protocol comparison, not confirmation of efficacy.
Registry: NCT03784027. Registered endpoint checked: Time in Target (3.9 to 10.0 mmol/l) (70 to 180 mg/dl) (16-week home stay). Eligibility check: Registry age 1 Year to 7 Years; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Accessible primary literature: Cambridge Hybrid Closed-Loop System in Very Young Children With Type 1 Diabetes Reduces Caregivers' Fear of Hypoglycemia and Improves Their Well-Being.; Assessing the efficacy, safety and utility of closed-loop insulin delivery compared with sensor-augmented pump therapy in very young children with type 1 diabetes (KidsAP02 study): an open-label, multicentre, multinational, randomised cross-over study protocol.; Randomized Trial of Closed-Loop Control in Very Young Children with Type 1 Diabetes.. Limits: Primary abstract findings were available; supplementary tables and full adverse-event adjudication were not comprehensively re-reviewed. Registry eligibility is not a claim of current site availability.
canada-relatives-screening
Outcome: No new discrepancy identified in the reviewed summary, stated design, primary endpoint and eligibility against the available registry. This is a bounded protocol comparison, not confirmation of efficacy.
Registry: NCT07322380. Registered endpoint checked: Feasibility of screening and monitoring outcomes (Through study completion for positive screened participants: 3 years). Eligibility check: Registry age 18 Years to not specified; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Limits: No usable primary abstract was independently recovered in this pass for this record. Protocol/design wording was assessed; any existing detailed sponsor, conference or historical outcome claims require their cited source and were not independently certified through full-text review.
capillary-ogtt-home-children
Outcome: No new discrepancy identified in the reviewed summary, stated design, primary endpoint and eligibility against the available registry. This is a bounded protocol comparison, not confirmation of efficacy.
Registry: NCT06815081. Registered endpoint checked: To determine the agreement of capillary blood glucose levels to venous blood glucose levels during a standard OGTT (From enrolment to end of study visit on day 1.); To assess the feasibility of using the capillary OGTT device in the home environment (From enrolment to end of study visit on day 1). Eligibility check: Registry age not specified to 17 Years; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Limits: No usable primary abstract was independently recovered in this pass for this record. Protocol/design wording was assessed; any existing detailed sponsor, conference or historical outcome claims require their cited source and were not independently certified through full-text review.
carc101c-autoimmune-t1d
Outcome: No new discrepancy identified in the reviewed summary, stated design, primary endpoint and eligibility against the available registry. This is a bounded protocol comparison, not confirmation of efficacy.
Registry: NCT06546436. Registered endpoint checked: Incidence and severity of adverse events within 3 weeks after administration (NCI CTCAE V5.0). (21 days). Eligibility check: Registry age 18 Years to 40 Years; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Limits: No usable primary abstract was independently recovered in this pass for this record. Protocol/design wording was assessed; any existing detailed sponsor, conference or historical outcome claims require their cited source and were not independently certified through full-text review.
caresens-air3-cgm
Outcome: No new discrepancy identified in the reviewed summary, stated design, primary endpoint and eligibility against the available registry. This is a bounded protocol comparison, not confirmation of efficacy.
Registry: NCT07296276. Registered endpoint checked: Accuracy of the glucose concentration measurements (16 days). Eligibility check: Registry age 18 Years to 65 Years; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Limits: No usable primary abstract was independently recovered in this pass for this record. Protocol/design wording was assessed; any existing detailed sponsor, conference or historical outcome claims require their cited source and were not independently certified through full-text review.
cd6-car-treg-stage3
Outcome: No new discrepancy identified in the reviewed summary, stated design, primary endpoint and eligibility against the available registry. This is a bounded protocol comparison, not confirmation of efficacy.
Registry: NCT07395050. Registered endpoint checked: Toxicity, CRS, ICANS, hyperglycemia/DKA (till 28 days post investigational drug infusion); Feasibility of investigational product manufacture (till 28 days post investigational drug infusion). Eligibility check: Registry age 18 Years to 35 Years; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Limits: No usable primary abstract was independently recovered in this pass for this record. Protocol/design wording was assessed; any existing detailed sponsor, conference or historical outcome claims require their cited source and were not independently certified through full-text review.
celregen-crg-002-ipsc-islets
Outcome: No new discrepancy identified in the reviewed summary, stated design, primary endpoint and eligibility against the available registry. This is a bounded protocol comparison, not confirmation of efficacy.
Registry: NCT07503028. Registered endpoint checked: Safety as assessed by number of adverse events accoridng to CTCAE v 6.0 (Within one year after CRG-002 transplantation). Eligibility check: Registry age 18 Years to 70 Years; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Limits: No usable primary abstract was independently recovered in this pass for this record. Protocol/design wording was assessed; any existing detailed sponsor, conference or historical outcome claims require their cited source and were not independently certified through full-text review.
celz-201-create-1
Outcome: No new discrepancy identified in the reviewed summary, stated design, primary endpoint and eligibility against the available registry. This is a bounded protocol comparison, not confirmation of efficacy.
Registry: NCT05626712. Registered endpoint checked: Number of Participants with Adverse Events (6 months). Eligibility check: Registry age 18 Years to 35 Years; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Limits: No usable primary abstract was independently recovered in this pass for this record. Protocol/design wording was assessed; any existing detailed sponsor, conference or historical outcome claims require their cited source and were not independently certified through full-text review.
cir0602k-aid-insulin-sensitizer
Outcome: No new discrepancy identified in the reviewed summary, stated design, primary endpoint and eligibility against the available registry. This is a bounded protocol comparison, not confirmation of efficacy.
Registry: NCT07186660. Registered endpoint checked: Glucose Time-in-Range (12 weeks). Eligibility check: Registry age 18 Years to 45 Years; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Limits: No usable primary abstract was independently recovered in this pass for this record. Protocol/design wording was assessed; any existing detailed sponsor, conference or historical outcome claims require their cited source and were not independently certified through full-text review.
ckm-sglt2i-safe-use
Outcome: Corrected claim that trial tests monitor reducing ketones; registered comparisons concern sotagliflozin doses and insulin-delivery groups.
Registry: NCT07211802. Registered endpoint checked: BHB Time Above 0.6mmol/L - 200mg (6 weeks); BHB Time Above 0.6mmol/L - 400mg (6 weeks). Eligibility check: Registry age 18 Years to not specified; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Limits: No usable primary abstract was independently recovered in this pass for this record. Protocol/design wording was assessed; any existing detailed sponsor, conference or historical outcome claims require their cited source and were not independently certified through full-text review.
ckm-sotagliflozin-dka-kidney
Outcome: No new discrepancy identified in the reviewed summary, stated design, primary endpoint and eligibility against the available registry. This is a bounded protocol comparison, not confirmation of efficacy.
Registry: NCT07325201. Registered endpoint checked: Change in time in ketone range >1.5/mmol/L (3 months, 6 months, 9 months); Number of episodes of diabetic ketoacidosis (DKA) (6 months, 9 months). Eligibility check: Registry age 18 Years to 75 Years; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Limits: No usable primary abstract was independently recovered in this pass for this record. Protocol/design wording was assessed; any existing detailed sponsor, conference or historical outcome claims require their cited source and were not independently certified through full-text review.
close-it-aid-without-meal-announcement
Outcome: Removed retired roadmap links; checked registry/endpoints or accessible primary abstract. Full results/safety tables were not accessible; no new efficacy inferred.
Registry: ACTRN12622001400752. Accessible primary literature: Glycemic Outcomes During Outpatient Use of Automated Insulin Delivery Without Meal Announcement in Adults with Type 1 Diabetes: Results from the CLOSE IT Randomized Controlled Trial.. Limits: Primary abstract findings were available; supplementary tables and full adverse-event adjudication were not comprehensively re-reviewed. Registry eligibility is not a claim of current site availability. Specific unresolved access limit: The accessible primary abstract supports 73 randomized participants and adjusted −2.2 percentage-point TIR difference (95% CI −6.2 to 1.7). It does not expose detailed hypoglycemia/DKA tables or establish a general safety conclusion. Full report device configuration and noninferiority-margin detail were not independently verified.
closed-loop-pregnancy-commercial-open-source
Outcome: No new discrepancy identified in the reviewed summary, stated design, primary endpoint and eligibility against the available registry. This is a bounded protocol comparison, not confirmation of efficacy.
Registry: NCT06654713. Registered endpoint checked: Large for gestational age (LGA) (At delivery); Core score on Type 1 Diabetes Distress Assessment Scale (T1-DDAS) (From enrollment to 8 weeks postpartum); Hypertensive disorders of pregnancy (HDP) (From enrollment to 8 weeks postpartum.); Time in pregnancy-specific range (psTIR) (From enrollment to 8 weeks postpartum.). Eligibility check: Registry age 18 Years to not specified; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Limits: No usable primary abstract was independently recovered in this pass for this record. Protocol/design wording was assessed; any existing detailed sponsor, conference or historical outcome claims require their cited source and were not independently certified through full-text review.
cnk-ut009-cell-injection
Outcome: Removed body contradiction claiming Phase1 when registry and frontmatter sayN/A.
Registry: NCT07051564. Registered endpoint checked: CNK-UT009 cell injection for the treatment of patients with type 1 diabetes Evaluation of the safety and tolerability of the user (The first cycle lasts for 21 days. The second to the fourth cycles each last for 14 days. The treatment follow-up period lasted for a total of 12 months); CNK-UT009 cell injection for the treatment of patients with type 1 diabetes Evaluation of the effectiveness of it (The first cycle lasts for 21 days. The second to the fourth cycles each last for 14 days. The treatment follow-up period lasted for a total of 12 months). Eligibility check: Registry age 18 Years to 65 Years; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Limits: No usable primary abstract was independently recovered in this pass for this record. Protocol/design wording was assessed; any existing detailed sponsor, conference or historical outcome claims require their cited source and were not independently certified through full-text review.
cnp-103-tolerogenic-nanoparticle
Outcome: Removed retired roadmap links; checked registry/endpoints or accessible primary abstract. Full results/safety tables were not accessible; no new efficacy inferred.
Registry: NCT06783309. Registered endpoint checked: Safety (Day 1 Through Day 365); Immune Safety (Day 1 Through Day 365). Eligibility check: Registry age 12 Years to 35 Years; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Limits: No usable primary abstract was independently recovered in this pass for this record. Protocol/design wording was assessed; any existing detailed sponsor, conference or historical outcome claims require their cited source and were not independently certified through full-text review.
continuous-glucose-ketone-feasibility
Outcome: No new discrepancy identified in the reviewed summary, stated design, primary endpoint and eligibility against the available registry. This is a bounded protocol comparison, not confirmation of efficacy.
Registry: NCT06977633. Registered endpoint checked: Concentration of Glucose Measured by Experimental CGM-CKM Sensor Compared to Blood Glucose (5 hours); Concentration of Ketones Measured by Experimental CGM-CKM Sensor Compared to Blood Ketones (5 hours). Eligibility check: Registry age 18 Years to 65 Years; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Limits: No usable primary abstract was independently recovered in this pass for this record. Protocol/design wording was assessed; any existing detailed sponsor, conference or historical outcome claims require their cited source and were not independently certified through full-text review.
control-iq-idcl-pivotal
Outcome: No new discrepancy identified in the reviewed summary, stated design, primary endpoint and eligibility against the available registry. This is a bounded protocol comparison, not confirmation of efficacy.
Registry: NCT03563313. Registered endpoint checked: Time in Target Range (26 weeks). Eligibility check: Registry age 14 Years to not specified; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Accessible primary literature: Outcomes in Pump- and CGM-Baseline Use Subgroups in the International Diabetes Closed-Loop Trial.; Six-Month Randomized, Multicenter Trial of Closed-Loop Control in Type 1 Diabetes.. Limits: Primary abstract findings were available; supplementary tables and full adverse-event adjudication were not comprehensively re-reviewed. Registry eligibility is not a claim of current site availability.
control-iq-young-children
Outcome: No new discrepancy identified in the reviewed summary, stated design, primary endpoint and eligibility against the available registry. This is a bounded protocol comparison, not confirmation of efficacy.
Registry: NCT03844789. Registered endpoint checked: Continuous Glucose Monitor (CGM)-Measured Percent Time in Range 70-180mg/dL Over 16 Week Trial Period (From randomization to data collection completion at the end of 16 weeks). Eligibility check: Registry age 6 Years to 13 Years; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Accessible primary literature: A Randomized Trial of Closed-Loop Control in Children with Type 1 Diabetes.; Successful At-Home Use of the Tandem Control-IQ Artificial Pancreas System in Young Children During a Randomized Controlled Trial.. Limits: Primary abstract findings were available; supplementary tables and full adverse-event adjudication were not comprehensively re-reviewed. Registry eligibility is not a claim of current site availability.
create-open-source-aid
Outcome: Corrected device phase and New Zealand location; kept DANA-i, which the NEJM primary report explicitly confirms as preproduction; removed unsupported direct relationships to unrelated systems and overstated universal safety/equal subgroup effects.
Registry: ACTRN12620000034932. Accessible primary literature: Extended Use of an Open-Source Automated Insulin Delivery System in Children and Adults with Type 1 Diabetes: The 24-Week Continuation Phase Following the CREATE Randomized Controlled Trial.; Open-Source Automated Insulin Delivery in Type 1 Diabetes.; CREATE (Community deRivEd AutomaTEd insulin delivery) trial. Randomised parallel arm open label clinical trial comparing automated insulin delivery using a mobile controller (AnyDANA-loop) with an open-source algorithm with sensor augmented pump therapy in type 1 diabetes.. Limits: Primary abstract findings were available; supplementary tables and full adverse-event adjudication were not comprehensively re-reviewed. Registry eligibility is not a claim of current site availability.
dapagliflozin-pioglitazone-t1d
Outcome: No new discrepancy identified in the reviewed summary, stated design, primary endpoint and eligibility against the available registry. This is a bounded protocol comparison, not confirmation of efficacy.
Registry: NCT03878459. Registered endpoint checked: Decrease in HbA1c (28 weeks). Eligibility check: Registry age 18 Years to not specified; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Limits: No usable primary abstract was independently recovered in this pass for this record. Protocol/design wording was assessed; any existing detailed sponsor, conference or historical outcome claims require their cited source and were not independently certified through full-text review.
dapagliflozin-safe-ketone-thresholds
Outcome: No new discrepancy identified in the reviewed summary, stated design, primary endpoint and eligibility against the available registry. This is a bounded protocol comparison, not confirmation of efficacy.
Registry: NCT07225465. Registered endpoint checked: Percent time spent with interstitial ketones ≥3.0mmol/L (Main Study) (Commencement to end of study (12 weeks)); Percent of time spent with interstitial ketones ≥3.0mmol/L during exercise (Exercise Study) (Weeks 4 to12). Eligibility check: Registry age 24 Years to 85 Years; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Limits: No usable primary abstract was independently recovered in this pass for this record. Protocol/design wording was assessed; any existing detailed sponsor, conference or historical outcome claims require their cited source and were not independently certified through full-text review.
dblg1-closed-loop-proms
Outcome: No new discrepancy identified in the reviewed summary, stated design, primary endpoint and eligibility against the available registry. This is a bounded protocol comparison, not confirmation of efficacy.
Registry: NCT06154135. Registered endpoint checked: Time in range (12 months after start). Eligibility check: Registry age 18 Years to not specified; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Limits: No usable primary abstract was independently recovered in this pass for this record. Protocol/design wording was assessed; any existing detailed sponsor, conference or historical outcome claims require their cited source and were not independently certified through full-text review.
denosumab-beta-cell-t1d
Outcome: Replaced vague early-T1D label with actual1–5year duration, sex-specific minimum age and C-peptide entry criteria; named actual safety/efficacy endpoints.
Registry: NCT06524960. Registered endpoint checked: Primary safety endpoint (up to 12 months); Primary efficacy endpoint (up to 12 months). Eligibility check: Registry age 18 Years to 50 Years; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Limits: No usable primary abstract was independently recovered in this pass for this record. Protocol/design wording was assessed; any existing detailed sponsor, conference or historical outcome claims require their cited source and were not independently certified through full-text review.
designate-siplizumab
Outcome: No new discrepancy identified in the reviewed summary, stated design, primary endpoint and eligibility against the available registry. This is a bounded protocol comparison, not confirmation of efficacy.
Registry: NCT05574335. Registered endpoint checked: Number of Participants With a T Cell Phenotype Signature Response (Week 0 to Week 12). Eligibility check: Registry age 8 Years to 45 Years; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Limits: No usable primary abstract was independently recovered in this pass for this record. Protocol/design wording was assessed; any existing detailed sponsor, conference or historical outcome claims require their cited source and were not independently certified through full-text review.
detect-t1d-gulf-screening
Outcome: No new discrepancy identified in the reviewed summary, stated design, primary endpoint and eligibility against the available registry. This is a bounded protocol comparison, not confirmation of efficacy.
Registry: NCT07038473. Registered endpoint checked: Proportion of at-risk (first-degree) relatives of T1D probands who meet the diagnostic criteria for Stage 1 or Stage 2 T1D (At Baseline (screening visit) and in 3 months, at Visit 2 (confirmatory visit)). Eligibility check: Registry age 18 Months to 18 Years; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Limits: No usable primary abstract was independently recovered in this pass for this record. Protocol/design wording was assessed; any existing detailed sponsor, conference or historical outcome claims require their cited source and were not independently certified through full-text review.
dfmo-tadpol-polyamines
Outcome: No new discrepancy identified in the reviewed summary, stated design, primary endpoint and eligibility against the available registry. This is a bounded protocol comparison, not confirmation of efficacy.
Registry: NCT05594563. Registered endpoint checked: Clinical efficacy of 1000 mg/m2/day of oral DFMO after 6 months of treatment (6 month); Number of participants with treatment-related adverse events as assessed by CTCAE v5 (through study completion, an average of one year). Eligibility check: Registry age 4 Years to 40 Years; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Limits: No usable primary abstract was independently recovered in this pass for this record. Protocol/design wording was assessed; any existing detailed sponsor, conference or historical outcome claims require their cited source and were not independently certified through full-text review.
diaconn-p8-smart-pen
Outcome: No new discrepancy identified in the reviewed summary, stated design, primary endpoint and eligibility against the available registry. This is a bounded protocol comparison, not confirmation of efficacy.
Registry: NCT06406439. Registered endpoint checked: Change in HbA1c(%) at 12 weeks compared to baseline (from baseline to the 12-week time point). Eligibility check: Registry age 19 Years to 75 Years; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Limits: No usable primary abstract was independently recovered in this pass for this record. Protocol/design wording was assessed; any existing detailed sponsor, conference or historical outcome claims require their cited source and were not independently certified through full-text review.
diagnode-1-gad-alum
Outcome: Qualified safety inference from12-person uncontrolled pilot; registry primary safety and published immune-response signal checked, not proof of efficacy.
Registry: NCT02352974. Registered endpoint checked: Number of Subjects With Injection Site Reactions Month 1 (Month 1); Number of Subjects With Injection Site Reactions Month 2 (Month 2); Number of Subjects With Injection Site Reactions Month 3 (Month 3); Number of Subjects With Injection Site Reactions Month 32 (Month 32, extension period). Eligibility check: Registry age 12 Years to 30 Years; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Accessible primary literature: Intralymphatic Glutamic Acid Decarboxylase-Alum Administration Induced Th2-Like-Specific Immunomodulation in Responder Patients: A Pilot Clinical Trial in Type 1 Diabetes.. Limits: Primary abstract findings were available; supplementary tables and full adverse-event adjudication were not comprehensively re-reviewed. Registry eligibility is not a claim of current site availability.
diagnode-2-gad-alum
Outcome: Removed prompt-history note from public narrative. Primary overall null result and prespecified genotype subgroup checked against the primary abstract; subgroup benefit is not confirmation of overall efficacy.
Registry: NCT03345004. Registered endpoint checked: Change in Stimulated C-peptide During a MMTT (Baseline and 15 months). Eligibility check: Registry age 12 Years to 24 Years; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Accessible primary literature: Intralymphatic GAD-Alum (Diamyd®) Improves Glycemic Control in Type 1 Diabetes With HLA DR3-DQ2.; Intralymphatic Glutamic Acid Decarboxylase With Vitamin D Supplementation in Recent-Onset Type 1 Diabetes: A Double-Blind, Randomized, Placebo-Controlled Phase IIb Trial.; Intralymphatic GAD-Alum (Diamyd®) Improves Glycemic Control in Type 1 Diabetes With HLA DR3-DQ2.. Limits: Primary abstract findings were available; supplementary tables and full adverse-event adjudication were not comprehensively re-reviewed. Registry eligibility is not a claim of current site availability.
diagnode-3-gad-alum
Outcome: No new discrepancy identified in the reviewed summary, stated design, primary endpoint and eligibility against the available registry. This is a bounded protocol comparison, not confirmation of efficacy.
Registry: NCT05018585. Registered endpoint checked: Beta cell function (Baseline to 15 months); Glycemic control (Baseline to 15 months). Eligibility check: Registry age 12 Years to 28 Years; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Limits: No usable primary abstract was independently recovered in this pass for this record. Protocol/design wording was assessed; any existing detailed sponsor, conference or historical outcome claims require their cited source and were not independently certified through full-text review.
diamyd-at-risk-phase2
Outcome: No new discrepancy identified in the reviewed summary, stated design, primary endpoint and eligibility against the available registry. This is a bounded protocol comparison, not confirmation of efficacy.
Registry: NCT05683990. Registered endpoint checked: Occurrence of AEs (including Injection site reactions) and SAEs (From screening to 12 months.); Number of Clinically Significant Abnormal Results from Physical examinations, including neurological and Vital Signs assessments (From screening to 12 months.); Number of Clinically Significant Abnormal Results From Laboratory measurements, including hematology, clinical chemistry, metabolic status parameters (fasting C-peptide, HbA1c, fasting glucose) and urine analysis (From screening to 12 months.). Eligibility check: Registry age 8 Years to 18 Years; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Limits: No usable primary abstract was independently recovered in this pass for this record. Protocol/design wording was assessed; any existing detailed sponsor, conference or historical outcome claims require their cited source and were not independently certified through full-text review.
dimethyl-fumarate-newonset
Outcome: No new discrepancy identified in the reviewed summary, stated design, primary endpoint and eligibility against the available registry. This is a bounded protocol comparison, not confirmation of efficacy.
Registry: NCT07258394. Registered endpoint checked: Baseline-adjusted geometric mean area under the serum C-peptide curve (C-peptide AUC) during a 2-hour mixed-meal tolerance test (MMTT) 24 weeks post-intervention. (Post-intervention Weeks 24). Eligibility check: Registry age 18 Years to 65 Years; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Limits: No usable primary abstract was independently recovered in this pass for this record. Protocol/design wording was assessed; any existing detailed sponsor, conference or historical outcome claims require their cited source and were not independently certified through full-text review.
dimethyl-fumarate-open-label-adults
Outcome: No new discrepancy identified in the reviewed summary, stated design, primary endpoint and eligibility against the available registry. This is a bounded protocol comparison, not confirmation of efficacy.
Registry: NCT07548996. Registered endpoint checked: Baseline-Adjusted Geometric Mean Area Under the Serum C-Peptide Curve During a 2-Hour Mixed-Meal Tolerance Test (24 weeks after end of intervention (48 weeks after enrollment)). Eligibility check: Registry age 18 Years to 65 Years; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Limits: No usable primary abstract was independently recovered in this pass for this record. Protocol/design wording was assessed; any existing detailed sponsor, conference or historical outcome claims require their cited source and were not independently certified through full-text review.
dpt-1-parenteral-oral-insulin
Outcome: Corrected false prespecified label for oral-insulin high-IAA subgroup. Removed unrelated malformed DOI citation; retained original primary oral/injected-insulin publications.
Registry: NCT00004984. Registered endpoint checked: Rate of Type 1 Diabetes Per Year (Glucose tolerance is measured every 6 months for up to 6 years). Eligibility check: Registry age 3 Years to 45 Years; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Accessible primary literature: The DPT-1 trial: a negative result with lessons for future type 1 diabetes prevention.; Effects of oral insulin in relatives of patients with type 1 diabetes: The Diabetes Prevention Trial--Type 1.; Effects of insulin in relatives of patients with type 1 diabetes mellitus.; Clinical picture of childhood type 1 diabetes mellitus in the Eastern Province of Saudi Arabia.; The effects of co-therapy with recombinant human insulin-like growth factor I and insulin on serum leptin levels in adolescents with type 1 diabetes mellitus.. Limits: Primary abstract findings were available; supplementary tables and full adverse-event adjudication were not comprehensively re-reviewed. Registry eligibility is not a claim of current site availability. Citation integrity: Removed the malformed unrelated DOI 10.1046/j.1399-543x.2001.00000.x; primary oral and injected insulin reports support the overall null result.
e-islet-01-allogeneic
Outcome: No new discrepancy identified in the reviewed summary, stated design, primary endpoint and eligibility against the available registry. This is a bounded protocol comparison, not confirmation of efficacy.
Registry: NCT07126873. Registered endpoint checked: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (From E-islet 01 infusion to end of study (up to 5 years)); Proportion of Participants Free of Severe Hypoglycemic Events With Either a Glycated Haemoglobin (HbA1c) <7.0% or a ≥ 1% Reduction in Glycosylated hemoglobin(HbA1c) From Baseline (At 1 year after E-islet 01 infusion). Eligibility check: Registry age 18 Years to 75 Years; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Limits: No usable primary abstract was independently recovered in this pass for this record. Protocol/design wording was assessed; any existing detailed sponsor, conference or historical outcome claims require their cited source and were not independently certified through full-text review.
early-aid-newly-diagnosed-pilot
Outcome: No new discrepancy identified in the reviewed summary, stated design, primary endpoint and eligibility against the available registry. This is a bounded protocol comparison, not confirmation of efficacy.
Registry: NCT07501338. Registered endpoint checked: Number of participants who started AID System within 2 weeks (2 Weeks). Eligibility check: Registry age 2 Years to 26 Years; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Limits: No usable primary abstract was independently recovered in this pass for this record. Protocol/design wording was assessed; any existing detailed sponsor, conference or historical outcome claims require their cited source and were not independently certified through full-text review.
early-aid-therapy-cost-effectiveness
Outcome: No new discrepancy identified in the reviewed summary, stated design, primary endpoint and eligibility against the available registry. This is a bounded protocol comparison, not confirmation of efficacy.
Registry: NCT07423637. Registered endpoint checked: Time in Range (During the first 2 years). Eligibility check: Registry age 7 Years to 16 Years; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Limits: No usable primary abstract was independently recovered in this pass for this record. Protocol/design wording was assessed; any existing detailed sponsor, conference or historical outcome claims require their cited source and were not independently certified through full-text review.
empagliflozin-aid
Outcome: No new discrepancy identified in the reviewed summary, stated design, primary endpoint and eligibility against the available registry. This is a bounded protocol comparison, not confirmation of efficacy.
Registry: NCT06021145. Registered endpoint checked: Percentage of time of glucose levels spent in the target range (empagliflozin vs placebo) (4 weeks). Eligibility check: Registry age 18 Years to not specified; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Limits: No usable primary abstract was independently recovered in this pass for this record. Protocol/design wording was assessed; any existing detailed sponsor, conference or historical outcome claims require their cited source and were not independently certified through full-text review.
encellin-enc-103-hpi
Outcome: No new discrepancy identified in the reviewed summary, stated design, primary endpoint and eligibility against the available registry. This is a bounded protocol comparison, not confirmation of efficacy.
Registry: NCT07680673. Registered endpoint checked: Rate of device-related adverse events (AEs) (4.5-5 months). Eligibility check: Registry age 18 Years to 75 Years; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Limits: No usable primary abstract was independently recovered in this pass for this record. Protocol/design wording was assessed; any existing detailed sponsor, conference or historical outcome claims require their cited source and were not independently certified through full-text review.
encellin-enc-201-encrt
Outcome: No new discrepancy identified in the reviewed summary, stated design, primary endpoint and eligibility against the available registry. This is a bounded protocol comparison, not confirmation of efficacy.
Registry: NCT06408311. Registered endpoint checked: Safety (Day 1 through Day 134). Eligibility check: Registry age 18 Years to 70 Years; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Limits: No usable primary abstract was independently recovered in this pass for this record. Protocol/design wording was assessed; any existing detailed sponsor, conference or historical outcome claims require their cited source and were not independently certified through full-text review.
eversense-gemini
Outcome: No new discrepancy identified in the reviewed summary, stated design, primary endpoint and eligibility against the available registry. This is a bounded protocol comparison, not confirmation of efficacy.
Registry: NCT07386340. Registered endpoint checked: System agreement (15/15%, 20/20%, 30/30%, and 40/40%) for paired sensor FGM and reference measurements post-insertion for reference glucose values from 40-400 mg/dL. (365 days); Number of device-related or sensor insertion/removal procedure-related serious adverse events (365 days). Eligibility check: Registry age 18 Years to not specified; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Limits: No usable primary abstract was independently recovered in this pass for this record. Protocol/design wording was assessed; any existing detailed sponsor, conference or historical outcome claims require their cited source and were not independently certified through full-text review.
eversense-nonadjunctive-postapproval
Outcome: No new discrepancy identified in the reviewed summary, stated design, primary endpoint and eligibility against the available registry. This is a bounded protocol comparison, not confirmation of efficacy.
Registry: NCT04836546. Registered endpoint checked: Incidence of moderate and severe hypoglycemic and diabetic ketoacidosis events (First 6 months (phase 1) compared to second 6 months (phase 2)). Eligibility check: Registry age 18 Years to not specified; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Limits: No usable primary abstract was independently recovered in this pass for this record. Protocol/design wording was assessed; any existing detailed sponsor, conference or historical outcome claims require their cited source and were not independently certified through full-text review.
extended-wear-infusion-set-options
Outcome: Expanded sparse summary/eligibility using current registry design, inclusion criteria and primary outcome; no efficacy inferred from registration.
Registry: NCT07325461. Registered endpoint checked: 7 Day Survival of Infusion Set for Primary Outcome Measure (6 weeks). Eligibility check: Registry age 18 Years to 80 Years; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Limits: No usable primary abstract was independently recovered in this pass for this record. Protocol/design wording was assessed; any existing detailed sponsor, conference or historical outcome claims require their cited source and were not independently certified through full-text review.
fabulinus-frexalimab
Outcome: No new discrepancy identified in the reviewed summary, stated design, primary endpoint and eligibility against the available registry. This is a bounded protocol comparison, not confirmation of efficacy.
Registry: NCT06111586. Registered endpoint checked: Change in mean 2h mixed meal tolerance test (MMTT) stimulated C-peptide concentration, calculated from AUC from baseline to W52 for Part B (12-21 y.o.) (Baseline to Week 52); Change in mean 2h mixed meal tolerance test (MMTT) stimulated C-peptide concentration, calculated from AUC from baseline to W26 for Part C (6-11 y.o.) (Baseline to Week 26). Eligibility check: Registry age 6 Years to 35 Years; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Accessible primary literature: A Phase 2 Trial of Frexalimab, a CD40L Antagonist, in Adolescents and Adults With Recent-Onset Type 1 Diabetes (FABULINUS): Rationale and Study Design.. Limits: Primary abstract findings were available; supplementary tables and full adverse-event adjudication were not comprehensively re-reviewed. Registry eligibility is not a claim of current site availability.
fine-one-finerenone-t1d-ckd
Outcome: No new discrepancy identified in the reviewed summary, stated design, primary endpoint and eligibility against the available registry. This is a bounded protocol comparison, not confirmation of efficacy.
Registry: NCT05901831. Registered endpoint checked: Change in Urinary albumin-to-creatinine ratio (UACR) (From baseline up to 6 months). Eligibility check: Registry age 18 Years to not specified; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Accessible primary literature: Finerenone in Type 1 Diabetes and Chronic Kidney Disease.. Limits: Primary abstract findings were available; supplementary tables and full adverse-event adjudication were not comprehensively re-reviewed. Registry eligibility is not a claim of current site availability.
flair-advanced-hcl-adolescents
Outcome: Aligned integer maximum age with protocol age<30 (registry header rounds to30); removed stigmatizing wording and restored missing primary-paper and registry footnote definitions.
Registry: NCT03040414. Registered endpoint checked: Percentage of Time Glucose Levels Were > 180 mg/dL (10.0 mmol/L) From 6 AM to 11:59 PM (12 weeks for each arm of the crossover); Non-inferiority for Percent of Time <54 mg/dL (3.0 mmol/L) During the Entire 24-hour Period. (12 weeks for each arm of the crossover). Eligibility check: Registry age 14 Years to 30 Years; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Accessible primary literature: A comparison of two hybrid closed-loop systems in adolescents and young adults with type 1 diabetes (FLAIR): a multicentre, randomised, crossover trial.. Limits: Primary abstract findings were available; supplementary tables and full adverse-event adjudication were not comprehensively re-reviewed. Registry eligibility is not a claim of current site availability.
fr1da-screening
Outcome: Separated registered primary autoantibody outcome from secondary DKA/stress outcomes and qualified causal language; JAMA cohort denominator62 and2DKA checked.
Registry: NCT04039945. Registered endpoint checked: presence of multiple islet autoantibodies (up to 3 years). Eligibility check: Registry age 2 Years to 10 Years; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Accessible primary literature: Yield of a Public Health Screening of Children for Islet Autoantibodies in Bavaria, Germany.. Limits: Primary abstract findings were available; supplementary tables and full adverse-event adjudication were not comprehensively re-reviewed. Registry eligibility is not a claim of current site availability.
gastrin-improve-islet-transplant
Outcome: No new discrepancy identified in the reviewed summary, stated design, primary endpoint and eligibility against the available registry. This is a bounded protocol comparison, not confirmation of efficacy.
Registry: NCT03746769. Registered endpoint checked: Proportion of subjects who are insulin independent, free from severe hypoglycemia and have HbA1c less than or equal to 6.5% ("complete response") (1 year post transplant (6 months after second course of Gastrin)). Eligibility check: Registry age 18 Years to 68 Years; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Limits: No usable primary abstract was independently recovered in this pass for this record. Protocol/design wording was assessed; any existing detailed sponsor, conference or historical outcome claims require their cited source and were not independently certified through full-text review.
glp1ra-stage1-t1d
Outcome: Expanded sparse summary/eligibility using current registry design, inclusion criteria and primary outcome; no efficacy inferred from registration.
Registry: NCT07430332. Registered endpoint checked: C-peptide area under the curve (12 months); C-peptide area under the curve (AUC) (12 months). Eligibility check: Registry age 12 Years to 70 Years; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Limits: No usable primary abstract was independently recovered in this pass for this record. Protocol/design wording was assessed; any existing detailed sponsor, conference or historical outcome claims require their cited source and were not independently certified through full-text review.
gnti-122-polaris
Outcome: Corrected120→180-day diagnosis window and added essential genotype/C-peptide restrictions from current registry.
Registry: NCT06919354. Registered endpoint checked: Safety and tolerability of GNTI-122 with and without rapamycin in adult participants with recently diagnosed T1D (Week 78). Eligibility check: Registry age 18 Years to 55 Years; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Limits: No usable primary abstract was independently recovered in this pass for this record. Protocol/design wording was assessed; any existing detailed sponsor, conference or historical outcome claims require their cited source and were not independently certified through full-text review.
hdv-lispro-phase2b
Outcome: No new discrepancy identified in the reviewed summary, stated design, primary endpoint and eligibility against the available registry. This is a bounded protocol comparison, not confirmation of efficacy.
Registry: NCT06238778. Registered endpoint checked: hypoglycemia events (during the first 6 weeks of the maintenance period); hypoglycemia percentage of time (during the first 6 weeks of maintenance period). Eligibility check: Registry age 18 Years to 79 Years; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Limits: No usable primary abstract was independently recovered in this pass for this record. Protocol/design wording was assessed; any existing detailed sponsor, conference or historical outcome claims require their cited source and were not independently certified through full-text review.
home-ogtt-screening
Outcome: Added43kg weight threshold and distinct minimum age12 for recent-onset stage3 cohort; endpoint is measurement agreement not disease prevention.
Registry: NCT07155252. Registered endpoint checked: Accuracy of GTT@Home (up to 4 weeks from enrollment). Eligibility check: Registry age 8 Years to 45 Years; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Limits: No usable primary abstract was independently recovered in this pass for this record. Protocol/design wording was assessed; any existing detailed sponsor, conference or historical outcome claims require their cited source and were not independently certified through full-text review.
hybrid-closed-loop-effectiveness-adults
Outcome: Expanded sparse summary/eligibility using current registry design, inclusion criteria and primary outcome; no efficacy inferred from registration.
Registry: NCT06236607. Registered endpoint checked: Glucose time-in-range (TIR) of 70-180 mg/dL (baseline, 39 weeks). Eligibility check: Registry age 18 Years to 75 Years; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Limits: No usable primary abstract was independently recovered in this pass for this record. Protocol/design wording was assessed; any existing detailed sponsor, conference or historical outcome claims require their cited source and were not independently certified through full-text review.
hydroxychloroquine-prevention-tn22
Outcome: Retained futility result and secondary immune findings; qualified categorical safe claim to observed trial follow-up.
Registry: NCT03428945. Registered endpoint checked: Change From Treatment Assignment Glucose Tolerance to Abnormal Glucose Tolerance or Diabetes (Glucose tolerance is measured every 6 months for up to 4 years). Eligibility check: Registry age 3 Years to not specified; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Accessible primary literature: Hydroxychloroquine in Stage 1 Type 1 Diabetes.. Limits: Primary abstract findings were available; supplementary tables and full adverse-event adjudication were not comprehensively re-reviewed. Registry eligibility is not a claim of current site availability.
hyperinsulinemia-adjunct-t1d
Outcome: Expanded sparse summary/eligibility using current registry design, inclusion criteria and primary outcome; no efficacy inferred from registration.
Registry: NCT06609356. Registered endpoint checked: Aim 1: Tissue glucose disposal (TGD) (8 hours); Aim 2: Nitric Oxide (NO) bioavailability (8 hours). Eligibility check: Registry age 18 Years to 60 Years; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Limits: No usable primary abstract was independently recovered in this pass for this record. Protocol/design wording was assessed; any existing detailed sponsor, conference or historical outcome claims require their cited source and were not independently certified through full-text review.
Direct trial–item relationship audit
Removed unrelated treatment/device relationships from abatacept-prevention-at-risk, abatacept-rituximab-combo, abatacept-tn09-newonset, adapt-minimed-780g, aidapt-closed-loop-pregnancy, bandit-baricitinib, cd6-car-treg-stage3, cnp-103-tolerogenic-nanoparticle, diagnode-1-gad-alum, diagnode-2-gad-alum, dpt-1-parenteral-oral-insulin, flair-advanced-hcl-adolescents, fr1da-screening, eversense-nonadjunctive-postapproval, create-open-source-aid. BANDIT now links to baricitinib; shared mechanism or background discussion alone no longer creates an advances-item relationship. CD6 CAR-Treg is not GNTI-122, CNP-103 is not GAD-alum/oral-insulin/PIpepTolDC, and the older Eversense non-adjunctive study is not evidence specifically for the 365-day device.