Full dated editorial ledger. Review depth and source access vary by record; these notes are not independent clinical certification. 91 records appear in this report.

Primary-agent trial review — 16 September 2026

Coverage: 90 records. GPT-Astra (xhigh). Registry comparison, targeted primary-source review and correction; independent clinical validation remains outstanding.

Scope and limits

Every listed record had its summary, reported status, registered endpoints and key eligibility compared with the retrieved current protocol where available. Outcome-level checks used primary abstracts, selected full reports, regulator documents or identified sponsor reports. The entries distinguish those checks. An unchanged protocol comparison does not certify every sentence of historical prose, every exclusion or every cited paper. Estimated dates and counts remain estimates; a registry status does not guarantee recruitment at a local site. Additional specialist historical reviews are recorded separately and complement this ledger.

adjust-t1d-semaglutide

Assessment: New historical RCT record from primary publication and posted results:72 randomized differs registry header 115;36% versus 0% composite, 26 weeks, two severe hypoglycemic events in each group and no DKA. Obesity and AID criteria explicit.

Registry: NCT05537233; COMPLETED; updated 2025-09-03; enrollment 115 (ACTUAL); results posted.

Endpoint comparison: Proportion of Adults With T1D Achieving Composite Outcome (CGM-measured Time in Range (TIR)>70% With Time Below Range (TBR) of <4% and Reduction in Body Weight by 5%) at 26 Weeks in the Semaglutide Group Compared to Placebo Group (26 weeks).

Sources for this record: ADJUnct Semaglutide Treatment in Type 1 Diabetes (NCT05537233) (registry); Semaglutide in Adults with Type 1 Diabetes and Obesity (peer-reviewed).

Limits: Source access and review depth vary. Registry fields establish the registered study, not clinical benefit, product approval or current local access. Cited-source reachability alone was not treated as verification of its claims.

ask-screening

Assessment: Checked official ASK program and locations pages. Current reach includes adults and home/Labcorp pathways, not just Colorado children; ages and unrelated teplizumab links corrected. Historical cohort outcomes remain distinct from current service access.

Sources for this record: ASK Research Program: eligibility and screening (community); ASK: screening locations and at-home options (community).

bcg-pediatric-t1d

Assessment: Corrected 150 from actual enrollment to registry estimate; active-not-recruiting status does not confirm final recruited count. Rewrote current-status prose and substantive eligibility; no pediatric efficacy results.

Registry: NCT05180591; ACTIVE_NOT_RECRUITING; updated 2026-06-26; enrollment 150 (ESTIMATED); results not posted.

Endpoint comparison: Change in HbA1c values (1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, and 5 years after initial BCG/placebo injection).

Sources for this record: NCT05180591: Repeat BCG vaccination in pediatric T1D (registry); NCT02081326: Repeat BCG vaccination in established (adult) T1D (registry).

beta-preserve-teplizumab-newonset

Assessment: September 14 registry: target 723 and estimated 2028 dates; endpoint regional/subgroup distinction corrected, including EU C-peptide age 5+ criterion. No results or extension of current labels inferred.

Registry: NCT07088068; RECRUITING; updated 2026-09-14; enrollment 723 (ESTIMATED); results not posted.

Endpoint comparison: For United States (US) and non-European Union (EU) countries: Glycated hemoglobin (HbA1c) change from baseline (From Baseline to Week 52); For US and non-EU countries: Total number of days without prandial insulin use (From baseline to Week 52); For EU countries: Change from baseline in mean 2 hours mixed meal tolerance test (MMTT) stimulated C-peptide concentration, calculated from Area Under the Curve (AUC) in participants 5 years and older (From baseline to Week 52); For EU countries: HbA1c change from baseline (From baseline to Week 52); For EU countries: Total number of days without prandial insulin use (From baseline to Week 52).

Sources for this record: A Study to Investigate Efficacy and Safety of Teplizumab Compared With Placebo in Participants 1 to 25 Years of Age With Stage 3 Type 1 Diabetes (registry); FDA Approves Drug for Pediatric Stage 3 Type I Diabetes (regulatory); Teplizumab and beta-Cell Function in Newly Diagnosed Type 1 Diabetes (peer-reviewed).

covalent-112-icovamenib

Assessment: Current registry now completed August 28, with 37 actual participants; previously terminated status corrected throughout. Prior five-person uncontrolled sponsor signal retained with limitations; no posted outcome tables or confirmatory efficacy implied.

Registry: NCT06152042; COMPLETED; updated 2026-08-28; enrollment 37 (ACTUAL); results not posted.

Endpoint comparison: To assess the effect on endogenous insulin secretion (26 Weeks).

Sources for this record: COVALENT-112: BMF-219 in participants with type 1 diabetes (NCT06152042) (registry); Biomea Fusion Announces Positive 52-Week Results from Phase 2 COVALENT-112 Trial in Type 1 Diabetes (manufacturer); Biomea Fusion Presents New Clinical and Translational Data for Icovamenib at the ADA 86th Scientific Sessions (conference); Biomea Fusion Announces BMF-219 in Diabetes Placed on Clinical Hold (manufacturer); FDA Lifts Clinical Hold on BMF-219 in Type 2 and Type 1 Diabetes Trials (manufacturer).

elsa-screening

Assessment: Official program says screening paused and ages2–17; corrected active-open3–13 presentation while distinguishing original cohort age bands. Historical observational screening outcomes are not new results from this refresh.

Sources for this record: The ELSA Study: current screening pause and age range (community); ELSA screening study ISRCTN97974414 (registry); Presentation and characteristics of children with screen-detected type 1 diabetes: learnings from the ELSA general population pediatric screening study (peer-reviewed).

genetic-recall-early-t1d-screening

Assessment: New biobank genetic-recall observational screening, target 150 ages18–79; selected polygenic risk, not a public population screening service.

Registry: NCT07802496; NOT_YET_RECRUITING; updated 2026-09-08; enrollment 150 (ESTIMATED); results not posted.

Endpoint comparison: Comparisons between high genetic risk vs. the rest of the cohort (12 months).

Sources for this record: Genetically Informed Screening for Early-Stage Type 1 Diabetes (NCT07802496) (registry).

hdv-lispro-phase2b

Assessment: Added June 7 Diasome primary sponsor report: composite primary endpoint failed; later maintenance analyses are secondary. Severe hypoglycemia 0 versus 5, P=.0598 not significant. Registry 227 versus sponsor 226 discrepancy retained explicitly below.

Registry: NCT06238778; COMPLETED; updated 2026-07-31; enrollment 227 (ACTUAL); results not posted.

Endpoint comparison: hypoglycemia events (during the first 6 weeks of the maintenance period); hypoglycemia percentage of time (during the first 6 weeks of maintenance period).

Sources for this record: NCT06238778: HDV-insulin lispro Phase 2b trial (registry); Diasome presents Phase 2b HDV-insulin lispro data (manufacturer).

ilet-bihormonal-feasibility

Assessment: Summary, current status, primary endpoint and key eligibility compared with the current registry. No additional discrepancy confirmed in that comparison. Historical outcome details beyond the primary sources explicitly discussed in the specialist ledgers were not all independently reverified.

Registry: NCT03840278; COMPLETED; updated 2019-12-16; enrollment 12 (ACTUAL); results posted.

Endpoint comparison: Percentage of Time That Valid CGM Glucose Readings Are Captured by the iLet Bionic Pancreas (Days 1-7); Percentage of Time That Each Drug Channel of the iLet Bionic Pancreas is Available (Days 1-7); The Ratio of Cumulative Drug Doses Delivered to Cumulative Drug Doses Attempted for Insulin and Dasiglucagon (Days 1-7).

Sources for this record: Performance of the Insulin-Only iLet Bionic Pancreas and the Bihormonal iLet Using Dasiglucagon in Adults With Type 1 Diabetes in a Home-Use Setting. (peer-reviewed); Castellanos LE, Balliro CA, Sherwood JS, et al. Diabetes Care (2021);44(6):e118-e120 (full text, PubMed Central PMC8247518) (peer-reviewed); The Bihormonal iLet Bionic Pancreas Feasibility Study. ClinicalTrials.gov, NCT03840278 (sponsor, collaborators, phase, design) (registry).

ilet-bionic-pancreas-pivotal

Registry: NCT04200313; COMPLETED; updated 2025-02-20; enrollment 440 (ACTUAL); results posted.

Endpoint comparison: HbA1c (13 weeks).

Sources for this record: Multicenter, Randomized Trial of a Bionic Pancreas in Type 1 Diabetes. (peer-reviewed); Jaeb Center for Health Research. The Insulin-Only Bionic Pancreas Pivotal Trial: Testing the iLet in Adults and Children With Type 1 Diabetes. ClinicalTrials.gov (NCT04200313) (registry); Beta Bionics. The iLet Bionic Pancreas Significantly Reduced HbA1c and Improved Time in Range vs Standard of Care. Healio / Beta Bionics press release (2022) (news); Positive Impact of the Bionic Pancreas on Diabetes Control in Youth 6-17 Years Old with Type 1 Diabetes: A Multicenter Randomized Trial. (peer-reviewed); Boston University. FDA Clears Bionic Pancreas Developed in BU Lab for People with Type 1 Diabetes. BU News (2023) (community).

ilet-experience-study

Registry: NCT06891898; RECRUITING; updated 2026-09-08; enrollment 1875 (ESTIMATED); results not posted.

Endpoint comparison: Severe Hypoglycemia/cognitive impairment (1 year).

Sources for this record: The iLet Experience Study (registry).

imatinib-newonset

Registry: NCT01781975; COMPLETED; updated 2020-02-11; enrollment 67 (ACTUAL); results posted.

Endpoint comparison: Area Under the Stimulated C-peptide Curve (AUC) Mean Over the First 2 Hours of a 4 Hour Mixed Meal Tolerance Test at the 1 Year Visit (Visit 9 (Week 52) at 0, 15, 30, 60, 90, 120 minutes post-dose).

Sources for this record: Imatinib therapy for patients with recent-onset type 1 diabetes (peer-reviewed); Imatinib Treatment in Recent Onset Type 1 Diabetes Mellitus (registry).

imc-s118ai-phase1

Registry: NCT07493122; NOT_YET_RECRUITING; updated 2026-03-25; enrollment 154 (ESTIMATED); results not posted.

Endpoint comparison: Number of participants with ≥1 treatment-emergent serious adverse event (SAE) (Up to 60 weeks); Number of participants with ≥1 treatment-emergent adverse event (AE) (Up to 45 weeks); Number of participants with clinically significant changes in safety laboratory parameters (Up to 45 weeks); Number of participants with clinically significant changes in vital signs (Up to 45 weeks); Number of participants with clinically significant changes in electrocardiogram (ECG) (Up to 45 weeks); Number of participants with dose interruptions, reductions, or discontinuations (Up to 21 weeks).

Sources for this record: Study of IMC-S118AI in Type 1 Diabetes (registry); Phase 1/1b study of IMC-S118AI in Type 1 Diabetes (registry).

immunostem-pdl1-hspc-gene-therapy

Registry: NCT06938334; NOT_YET_RECRUITING; updated 2025-04-22; enrollment 15 (ESTIMATED); results not posted.

Endpoint comparison: Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0 (Up to 24 months).

Sources for this record: NCT06938334: IMMUNOSTEM: PD-L1 gene-modified autologous HSPCs (registry).

indigo-halo-bright

Registry: NCT07745998; NOT_YET_RECRUITING; updated 2026-08-04; enrollment 12 (ESTIMATED); results not posted.

Endpoint comparison: Primary performance objective: Demonstration of Sensor accuracy (3 months); Primary performance objective: Demonstration of Sensor stability (3 months); Primary safety objective: Confirm safe implantation of the Sensor in human subcutaneous tissue (insertion procedural safety) (30 days); Primary safety objective: Confirm the safety of the device during the implantation period (3 months).

Sources for this record: NCT07745998: BRIGHT study of the Indigo HALO System (registry).

inhale-1st-afrezza-youth

Registry: NCT07224321; RECRUITING; updated 2026-08-13; enrollment 100 (ESTIMATED); results not posted.

Endpoint comparison: Percentage of participants with Continuous Glucose Meter (CGM) measured time in range (TIR) ≥70% (13 weeks).

Sources for this record: INHALE-1st Afrezza For Youth With Newly-Diagnosed Type 1 Diabetes (registry).

inhale-aidex-afrezza-exercise

Registry: NCT06880835; RECRUITING; updated 2026-07-16; enrollment 30 (ESTIMATED); results not posted.

Endpoint comparison: PHASE 1: Blood glucose <70 mg/dL (90 minutes); PHASE 2: Blood glucose <70 mg/dL (90 minutes).

Sources for this record: NCT06880835: INHALE-AIDEx — inhaled versus pump-delivered insulin around exercise (registry).

innodia-detect-family-friends

Registry: NCT07118098; RECRUITING; updated 2026-08-24; enrollment 30000 (ESTIMATED); results not posted.

Endpoint comparison: Presence of one or more T1D IAb (End of 2027).

Sources for this record: INNODIA Family & Friends Early-Stage T1D Detection Protocol (INNODIA DETECT) (registry).

inpen-pediatric-t1d

Registry: NCT05515939; ACTIVE_NOT_RECRUITING; updated 2026-08-20; enrollment 34 (ESTIMATED); results not posted.

Endpoint comparison: Change in Hemoglobin A1c (HbA1c) (Baseline to 12 and 24 weeks (End of study)).

Sources for this record: Evaluating the InPen in Pediatric Type 1 Diabetes (registry).

inreda-dual-hormone-ap

Registry: NCT05669547; COMPLETED; updated 2026-01-21; enrollment 243 (ACTUAL); results not posted.

Endpoint comparison: Time in Range (TIR) at 12 months (measured with an independent FSL Pro IQ sensor) (12 months).

Sources for this record: NCT05669547: study record (registry).

insulin-icodec-phase3-t1d

Registry: NCT07076199; ACTIVE_NOT_RECRUITING; updated 2026-09-01; enrollment 877 (ESTIMATED); results not posted.

Endpoint comparison: Change in glycosylated haemoglobin (HbA1c) (From baseline (week 0) to week 26).

Sources for this record: NCT07076199: Once-weekly insulin icodec phase 3 in T1D (registry).

insulin-icodec-real-world-t1d

Registry: NCT07160816; ACTIVE_NOT_RECRUITING; updated 2026-09-09; enrollment 245 (ESTIMATED); results not posted.

Endpoint comparison: Change in glycated haemoglobin (HbA1c) (Baseline (week 0), week 26).

Sources for this record: A Research Study to See How Insulin Icodec Helps People With Type 1 Diabetes Control Their Blood Sugar (registry).

insulin-producing-stem-cell-transplant-youth

Registry: NCT06951074; RECRUITING; updated 2025-04-30; enrollment 20 (ESTIMATED); results not posted.

Endpoint comparison: Insulin producing mesenchymal stem cells efficacy in insulin production in vitro (1 year); Insulin producing mesenchymal stem cells efficacy in insulin production in vitro (1 year); Insulin producing mesenchymal stem cells efficacy in insulin production in vivo (1 year).

Sources for this record: NCT06951074: Autologous insulin-producing mesenchymal stem cells in youth (registry).

ipancreas-context-aware-aid

Assessment: Removed unrelated amylin treatment link and flagged passed registry estimate; no assumed completion.

Registry: NCT06676657; RECRUITING; updated 2025-04-11; enrollment 10 (ESTIMATED); results not posted.

Endpoint comparison: Percent of time with sensor glucose less than 70 mg/dl (entire 4 week study); Percent of time with sensor glucose less than 54 mg/dl (entire 4 week study); Percent of time the pattern evaluation windows occurred (entire 4 week study); Percent of time with sensor glucose greater than 250 mg/dl (entire 4 week study).

Sources for this record: NCT06676657: iPancreas context-aware fully closed-loop AID (registry).

islet-transplant-anterior-chamber-eye

Registry: NCT02846571; RECRUITING; updated 2026-03-12; enrollment 2 (ESTIMATED); results not posted.

Endpoint comparison: Absence of ocular complications (24 months after transplant); Absence of sympathetic ophthalmia (24 months after transplant); Confirmation of intraocular islet graft survival (24 months after transplant).

Sources for this record: NCT02846571 — Pancreatic Islet Transplantation Into the Anterior Chamber of the Eye (registry); Intraocular Islet Transplant (manufacturer); Local release of rapamycin by microparticles delays islet rejection within the anterior chamber of the eye (peer-reviewed).

islet-transplant-brittle-t1d-chicago

Registry: NCT01630850; RECRUITING; updated 2025-12-09; enrollment 20 (ESTIMATED); results not posted.

Endpoint comparison: HbAlc <7.0% and an absence of severe hypoglycemic events (1 year).

Sources for this record: NCT01630850: Islet transplantation in brittle T1D (registry).

islet-transplant-glucocorticoid-free

Registry: NCT00706420; ACTIVE_NOT_RECRUITING; updated 2025-12-05; enrollment 17 (ACTUAL); results not posted.

Endpoint comparison: Percent of subjects who have achieved insulin independence post transplant. (3, 6, 12, and 24 months).

Sources for this record: NCT00706420: Islet transplantation with glucocorticoid-free immunosuppression (registry).

islet-transplant-nonuremic-phase3

Registry: NCT01897688; COMPLETED; updated 2026-06-18; enrollment 10 (ACTUAL); results posted.

Endpoint comparison: Safety and Feasibility of Islet Transplantation to Treat Type-1 Diabetes (T1D) (Two years after the final islet transplant.).

Sources for this record: NCT01897688: Single-center phase 3 islet transplantation in non-uremic T1D (registry); NCT01897688 posted results: participant flow, outcome measures and adverse events (registry).

islet-transplant-tcell-depletion-gastrin

Registry: NCT01909245; ACTIVE_NOT_RECRUITING; updated 2025-11-10; enrollment 10 (ACTUAL); results not posted.

Endpoint comparison: Proportion of subjects who are insulin independent, hypoglycemia free, AND with hemoglobin A1c < or = 6.5% at 1 year post-transplant (1 year post-transplant); Proportion of subjects who are insulin independent, hypoglycemia free, AND with hemoglobin A1c < or = 6.5% at 2 years post-transplant (2 years post-transplant); Proportion of subjects who are insulin independent, hypoglycemia free, AND with hemoglobin A1c < or = 6.5% at 5 years post-transplant (5 years post-transplant).

Sources for this record: NCT01909245: Islet transplant with T-cell depletion and gastrin (registry).

islet-transplant-tregs-bone-marrow

Registry: NCT05973734; ENROLLING_BY_INVITATION; updated 2026-06-08; enrollment 24 (ESTIMATED); results not posted.

Endpoint comparison: Occurrence of Grade 3 to 5 cytokine release syndrome / acute infusion reaction after Treg administration infusion reaction after Treg administration (within 3 months); Occurrence of grade 4 or greater adverse events of islet transplantation (Within two years); Number of patients who receive Treg infusions (Arm1) or Donor Derived Vertebral Bone Marrow (Arm2) and islet transplantation (feasibility) (Within two years).

Sources for this record: NCT05973734: Islet transplantation with recipient Tregs or donor bone marrow (registry).

ixekizumab-i-dit

Registry: NCT04589325; ACTIVE_NOT_RECRUITING; updated 2026-04-27; enrollment 127 (ESTIMATED); results not posted.

Endpoint comparison: Residual insulin secretion (12 months).

Sources for this record: NCT04589325: I-DIT: ixekizumab anti-IL-17 in new-onset T1D (registry).

jakpot-selective-jak-inhibitors

Registry: NCT05743244; ACTIVE_NOT_RECRUITING; updated 2026-09-02; enrollment 78 (ESTIMATED); results not posted.

Endpoint comparison: The area under the stimulated C-peptide curve (Y_AUC) (12 Months).

Sources for this record: JAK inhibitors to preserve C-peptide production in new-onset T1D (registry).

ketone-monitoring-sglt2i-dka

Registry: NCT07421518; NOT_YET_RECRUITING; updated 2026-02-19; enrollment 75 (ESTIMATED); results not posted.

Endpoint comparison: Ketone events with Beta-hydroxybutyrate (BOHB) >1.5 mmol/L (6 months).

Sources for this record: Ketone Monitoring Approaches for Diabetic Ketoacidosis Risk Mitigation in People With T1D on Adjunctive SGLT-2 Inhibitors (registry).

labpatch-glucose-sensing-precision

Assessment: Clarified mixed T1D/T2D insulin-treated population and measurement-study limits; not a cleared dosing sensor.

Registry: NCT05754281; ACTIVE_NOT_RECRUITING; updated 2026-05-29; enrollment 60 (ESTIMATED); results not posted.

Endpoint comparison: Mean absolute relative difference (MARD) (Baseline, every 15 minutes for a total of 6 hours).

Sources for this record: NCT05754281: LabPatch glucose sensing system accuracy (registry).

ladarixin-recent-onset-low-cpeptide

Assessment: New missed negative trial: terminated for futility; August 31 posted primary analysis: 140 vs registry header 289. Adjusted log-scale estimate/P value and inconsistent unit labels explained; no conversion to insulin production percentage.

Registry: NCT04628481; TERMINATED; updated 2026-08-31; enrollment 289 (ACTUAL); results posted.

Endpoint comparison: Change From Baseline in 2-hour Area Under the Concentration-time Curve (AUC) of C-peptide Response to the Mixed Model Tolerance Test (MMTT) (Baseline and at Month 6).

Sources for this record: A Study of Oral Ladarixin in Recent Onset Type 1 Diabetes and a Low Residual β-cell Function (NCT04628481) (registry).

lantidra-donislecel-cit07

Assessment: Corrected product identity: CIT-07 has 48 participants and is distinct from Lantidra’s UIH 001/UIH 002 registration studies totaling 30. Primary CIT-07 abstract and FDA regulatory review support the distinction, outcomes and major harms.

Registry: NCT00434811; COMPLETED; updated 2019-07-17; enrollment 48 (ACTUAL); results not posted.

Endpoint comparison: Proportion of participants with a HbA1c less than 7.0% AND free of severe hypoglycemic events (From Day 28 to Day 365 (inclusive) following the first islet transplant, with the day of transplant designated Day 0).

Sources for this record: Phase 3 Trial of Transplantation of Human Islets in Type 1 Diabetes Complicated by Severe Hypoglycemia (peer-reviewed); FDA Summary Basis for Regulatory Action: Lantidra (regulatory); NCT00434811: study record (registry).

leiden-toldc-phase1b

Assessment: Current LUMC June 26 primary news confirms 10 planned participants and diagnosis within five years and first participant treatment; n=1 safety anecdote is not efficacy. Dynamic CTIS full record was not independently available in this pass.

Sources for this record: EUCT 2023-508558-25-01: Tolerogenic dendritic cell therapy in type 1 diabetes (registry); First patient treated in new phase of promising type 1 diabetes research (news).

low-dose-atg-gcsf-haller

Registry: NCT02215200; COMPLETED; updated 2020-03-02; enrollment 89 (ACTUAL); results posted.

Endpoint comparison: Change in Area Under the Stimulated C-peptide Curve From Baseline to 12 Months. (-10, 0 15, 30, 60, 90, and 120 minutes post-dose at baseline and 12 months).

Sources for this record: Low-Dose Anti-Thymocyte Globulin Preserves C-Peptide, Reduces HbA<sub>1c</sub>, and Increases Regulatory to Conventional T-Cell Ratios in New-Onset Type 1 Diabetes: Two-Year Clinical Trial Data. (peer-reviewed); Low-Dose Anti-Thymocyte Globulin (ATG) Preserves β-Cell Function and Improves HbA<sub>1c</sub> in New-Onset Type 1 Diabetes. (peer-reviewed); National Institute of Diabetes and Digestive and Kidney Diseases (TrialNet). Antithymocyte Globulin (ATG) and Pegylated Granulocyte Colony Stimulating Factor (GCSF) in New Onset Type 1 Diabetes. ClinicalTrials.gov NCT02215200 (2014–2018) (registry).

low-dose-glucagon-aid-exercise

Assessment: Registry intervention is glucagon, not ZT01; removed unrelated Zucara product link.

Registry: NCT07427251; RECRUITING; updated 2026-08-13; enrollment 18 (ESTIMATED); results not posted.

Endpoint comparison: Change in plasma glucose (PG) from exercise initiation to the nadir during exercise and throughout the 2-hour post-exercise period between visit GCN and CHO (From exercise initiation until two hours following exercise).

Sources for this record: NCT07427251: Low-dose glucagon before exercise while using AID (registry).

luna-aid-system

Registry: NCT06627517; ACTIVE_NOT_RECRUITING; updated 2025-08-27; enrollment 120 (ESTIMATED); results not posted.

Endpoint comparison: Severe hypoglycemia events (From device activation to the end of treatment at 13 weeks); Diabetic ketoacidosis events (From device activation to the end of treatment at 13 weeks); Change in CGM-measured time in range (70-180 mg/dL) (From device activation to the end of treatment at 13 weeks).

Sources for this record: NCT06627517: Luna AID system safety and effectiveness (registry).

ly3938577-first-in-human

Assessment: Removed unsupported first-in-class/current-generation and inferred-safety claims. Healthy/T2D-only 66-person study with no posted results is development context, not T1D efficacy.

Registry: NCT06132126; COMPLETED; updated 2024-07-24; enrollment 66 (ACTUAL); results not posted.

Sources for this record: A Study to Investigate the Safety and Tolerability of LY3938577 in Healthy Participants and Participants With Type 2 Diabetes (registry).

ly3938577-t1d-phase1

Assessment: Corrected primary endpoints to include pharmacokinetics as well as safety. Distinguished healthy Part A from T1D cohorts, diagnosis duration, lowC-peptide and pump criteria. No results or proof of glucose-responsive action.

Registry: NCT06280703; RECRUITING; updated 2026-01-20; enrollment 118 (ESTIMATED); results not posted.

Endpoint comparison: Part A: Number of participants with one or more Adverse Event (s) (AEs), and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration. (Baseline up to Approximately Week 11); Part B and D: Number of participants with one or more Adverse Event (s) (AEs), and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration. (Baseline up to Week 10); Part A: Number of Participants With Clinically Significant Changes in Vital Signs (Baseline up to Approximately Week 11); Part B: Number of Participants With Clinically Significant Changes in Vital Signs (Baseline up to Week 10); Part A: Number of Participants With Clinically Significant Changes in Safety Laboratory Parameters (Baseline up to Approximately Week 11); Part B: Number of Participants With Clinically Significant Changes in Safety Laboratory Parameters (Baseline up to Week 10); Part A: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3938577 (Predose on day 1 up to week 13 post dose); Part A: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3938577 (Predose on day 1 up to week 13 post dose); Part B: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3938577 (Predose on day 1 up to week 13 post dose); Part C: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3938577 (Predose on day 1 up to week 13 post dose); Part D: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3938577 (Predose on day 1 up to week 13 post dose); Part A: PK: Maximum Observed Concentration (Cmax) of LY3938577 (Predose on day 1 up to week 13 post dose); Part B: PK: Maximum Observed Concentration (Cmax) of LY3938577 (Predose on day 1 up to week 13 post dose); Part C: PK: Concentration of LY3938577 (Predose on day 1 up to week 13 post dose).

Sources for this record: A Study of LY3938577 in Healthy Participants and Participants With Type 1 Diabetes Mellitus (T1DM) (registry).

ly3938577-t2d-phase2

Assessment: Removed globalmost advanced / best available claims. ExplicitT2D population and noninferiority question do not establish mechanism or benefit in T1D.

Registry: NCT07215312; ACTIVE_NOT_RECRUITING; updated 2026-07-13; enrollment 100 (ESTIMATED); results not posted.

Endpoint comparison: Change from Baseline in Glucose Time in Range Between 70 and 180 mg/dL Inclusive (Non-Inferiority Analysis) (Baseline through Week 20).

Sources for this record: A Study of LY3938577 in Participants With Type 2 Diabetes Previously Treated With Basal Insulin (registry).

mcgill-fcl-lyumjev-pramlintide

Assessment: Located publisher-deposited primary ADA abstract 1260-OR (DOI10.2337/db26-1260-or) through Crossref. Verified26 completers,5 percentage point noninferiority margin, failure of both comparisons, gastrointestinal events and no severe hypoglycemia/DKA. Removed secondary-report-only subgroup claims and replaced obsolete universal meal-announcement claim.

Registry: NCT06046417; UNKNOWN; updated 2024-04-18; enrollment 30 (ESTIMATED); results not posted.

Endpoint comparison: Percentage of time of glucose levels spent in the target range (3.9-10.0 mmol/L). (18 days).

Sources for this record: 1260-OR: Fully Closed-Loop Delivery of Ultra-Rapid Insulin Lispro and Pramlintide vs. Carbohydrate Counting in Type 1 Diabetes (conference); NCT06046417: study record (registry).

Limits: No full peer-reviewed outcome report was identified for the current study; a conference abstract cannot resolve unreported participant-level safety or attrition.

metmod-t1d-amx0035

Assessment: New 60-person Phase 2 protocol testing AMX0035 (sodium phenylbutyrate + taurursodiol) with clamp insulin sensitivity primary; research, not an available T1D treatment.

Registry: NCT07699380; RECRUITING; updated 2026-09-15; enrollment 60 (ESTIMATED); results not posted.

Endpoint comparison: Change in whole-body insulin sensitivity (M-value) measured by hyperinsulinemic-euglycemic clamp (Baseline, 24 weeks).

Sources for this record: METabolic MODulation to Enhance Insulin Sensitivity and Mitochondrial Function in Type 1 Diabetes (MetMod-T1D) (NCT07699380) (registry).

nnc0471-0119h-pump-clamp

Assessment: New missed completed 43-person Phase 1 pump clamp; pharmacodynamic outcome and lack of posted results distinguished from glucose-control benefit.

Registry: NCT06809621; COMPLETED; updated 2026-09-10; enrollment 43 (ACTUAL); results not posted.

Endpoint comparison: AUC(GIR,0-1h,basal-corrected): Area under the basal-corrected glucose infusion rate (GIR)-time curve from 0 to 1 hour (0 to 1 hour after bolus infusion).

Sources for this record: A Study to Test How Insulin NNC0471-0119 H Works in the Body in Participants With Type 1 Diabetes When Given by an Insulin Pump (NCT06809621) (registry).

panorama-bihormonal-pancreatectomy

Assessment: Located publisher-deposited primary ADA abstract 1257-OR (DOI10.2337/db26-1257-or) through Crossref. Corrected34 randomized / 20 in the primary analysis, time below range 0.9% versus 1.2% and nonsignificant difference. Removed uncorroborated25-person denominator and seven attributed discontinuations. Pancreatic diabetes explicitly distinguished from autoimmuneT1D; conference abstract remains limited.

Registry: NCT06346366; UNKNOWN; updated 2024-04-04; enrollment 40 (ESTIMATED); results not posted.

Endpoint comparison: Time in range (During open and closed loop treatment (both 3 months)).

Sources for this record: 1257-OR: Glucose Control during Three-Month Treatment with a Bihormonal Artificial Pancreas vs. Current Diabetes Care following Total Pancreatectomy (PANORAMA) (conference); PANORAMA randomized crossover trial: study protocol (peer-reviewed); NCT06346366: study record (registry).

Limits: No full peer-reviewed outcome report was identified for the current study; a conference abstract cannot resolve unreported participant-level safety or attrition.

semaglutide-aid-crossover

Assessment: New historical crossover RCT:28 randomized, 24 completed; time in range +4.8 percentage points,two euglycemic ketosis episodes. Full paper clarifies one severe event during placebo titration; no severe event on semaglutide. Abstract shorthand not treated as entire-trial safety.

Registry: NCT05205928; COMPLETED; updated 2025-01-22; enrollment 28 (ACTUAL); results not posted.

Endpoint comparison: Percentage of time of plasma glucose levels spent in target range (semaglutide vs placebo) (4 weeks).

Sources for this record: Weekly Subcutaneous Semaglutide as Adjunct to Closed-loop Therapy in Type 1 Diabetes Care (NCT05205928) (registry); Subcutaneous weekly semaglutide with automated insulin delivery in type 1 diabetes: a double-blind, randomized, crossover trial (peer-reviewed).

t1dal-alefacept

Assessment: Explained registry termination was manufacturer’s business discontinuation of Amevive, not proof of futility; preserved nonsignificantprimary 12-month outcome and separate secondary follow-up.

Registry: NCT00965458; TERMINATED; updated 2017-07-06; enrollment 49 (ACTUAL); results posted.

Endpoint comparison: 2-Hour C-peptide Area Under the Curve (AUC) Result in Response to Standardized Mixed Meal Tolerance Test (MMTT) (Baseline (pre-treatment initiation), Week 52).

Sources for this record: Targeting of memory T cells with alefacept in new-onset type 1 diabetes (peer-reviewed); Alefacept provides sustained clinical and immunological effects in new-onset type 1 diabetes patients (peer-reviewed); Inducing Remission in Type 1 Diabetes With Alefacept (registry).

t1ger-golimumab

Registry: NCT02846545; COMPLETED; updated 2025-02-04; enrollment 84 (ACTUAL); results posted.

Endpoint comparison: Active Treatment Period: C-peptide Area Under the Concentration-time Curve (AUC) Calculated From a 4 Hour Mixed Meal Tolerance Test (MMTT) at Week 52 (Week 52).

Sources for this record: Golimumab and Beta-Cell Function in Youth with New-Onset Type 1 Diabetes (peer-reviewed); A Study of SIMPONI to Arrest Beta-cell Loss in Type 1 Diabetes (registry).

tegoprubart-islet-transplant

Registry: NCT06305286; ACTIVE_NOT_RECRUITING; updated 2026-08-11; enrollment 70 (ESTIMATED); results not posted.

Endpoint comparison: Number of Participants who are insulin-independent post- first and final transplant (Day 75 and Day 365).

Sources for this record: Safety, Tolerability, and Efficacy of Immunomodulation With a Monoclonal Antibody Against CD40L in Combination With Transplanted Islet Cells in Adults With Brittle Type 1 Diabetes (registry); Eledon announces updated data from investigator-initiated islet transplant trial of tegoprubart in patients with type 1 diabetes at UChicago Medicine (manufacturer); Eledon announces updated data from investigator-initiated islet transplant trial of tegoprubart in patients with type 1 diabetes at UChicago Medicine (manufacturer); ADA 2026 recap: days 3 and 4 (community); CD40-CD40L Blockade: Update on Novel Investigational Therapeutics for Transplantation (peer-reviewed).

teplizumab-japan-stage2

Registry: NCT06791291; RECRUITING; updated 2026-07-01; enrollment 10 (ESTIMATED); results not posted.

Endpoint comparison: Number of participants with Stage 3 Type 1 Diabetes based on American Diabetes Association criteria (From baseline up to Week 104); Change from baseline in area under the curve (AUC) of C-peptide (From baseline up to Week 104); Change from baseline in AUC of endogenous insulin (From baseline up to Week 104); Number of participants with TEAEs, SAEs, AEs leading to permanent study intervention- or study discontinuation; AEs of special interest; number of participants with clinically significant changes in vital signs, ECG, and/or safety laboratory test (Throughout the study, approximately 756 days).

Sources for this record: NCT06791291: Teplizumab in Japanese stage-2 T1D (registry).

teplizumab-map-realworld

Registry: NCT07457580; RECRUITING; updated 2026-08-26; enrollment 60 (ESTIMATED); results not posted.

Endpoint comparison: Participant demographics at teplizumab initiation (At Day 1 (first dose of teplizumab)); Participants' family history of T1D and autoimmune diseases (At Day 1 (first dose of teplizumab)); Presence of T1D susceptibility genes (At Day 1 (first dose of teplizumab)); Presence of T1D susceptibility genes (At Day 1 (first dose of teplizumab)); Participants' medical history (From 6 months prior to the first dose of teplizumab (teplizumab initiation) (or the earliest date of all data contributing to Stage 2 T1D diagnosis, whichever is earlier) up to medical records abstraction date, approximately 3-4 years).

Sources for this record: Real-World Study of Patients With Type 1 Diabetes Treated With Teplizumab as Part of Managed Access Programs (MAPs) (registry).

teplizumab-pediatric-stage2

Registry: NCT05757713; ACTIVE_NOT_RECRUITING; updated 2026-01-30; enrollment 20 (ESTIMATED); results not posted.

Endpoint comparison: Treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), TEAEs leading to withdrawal, and serious adverse events (SAEs) (Through 104 Weeks).

Sources for this record: NCT05757713: Teplizumab in pediatric stage-2 T1D (registry).

three-seven-day-infusion-sets

Registry: NCT06532461; RECRUITING; updated 2024-08-06; enrollment 80 (ESTIMATED); results not posted.

Endpoint comparison: Occurence of hyperchogenicity at last two positions for infusions sets (2 weeks).

Sources for this record: NCT06532461: Three-day and seven-day infusion set trial (registry).

tirtle1-tirzepatide-t1d

Sources for this record: Tirzepatide in Type 1 Diabetes — Cardiometabolic Effects (TIRTLE1) (registry); Tirzepatide in Adults With Type 1 Diabetes: A Phase 2 Randomized Placebo-Controlled Clinical Trial (peer-reviewed).

tirtle2-tirzepatide-t1d

Registry: NCT06820281; RECRUITING; updated 2026-08-10; enrollment 44 (ESTIMATED); results not posted.

Endpoint comparison: Whole-body insulin sensitivity (6 weeks).

Sources for this record: TIRTLE2: Acute Metabolic Effects of Tirzepatide in Type 1 Diabetes (registry).

tirzepatide-aid-adjunct

Registry: NCT06630585; RECRUITING; updated 2026-01-26; enrollment 42 (ESTIMATED); results not posted.

Endpoint comparison: Change TIR (At week 16 of treatment.).

Sources for this record: GIP/GLP-1RA as Adjunctive to Automated Insulin Delivery in Adults With Type 1 Diabetes (registry).

tirzepatide-control-iq-no-meal

Registry: NCT07284511; RECRUITING; updated 2026-05-27; enrollment 105 (ESTIMATED); results not posted.

Endpoint comparison: Daytime Time-in-Range (During the final 6 weeks of the study).

Sources for this record: A Clinical Trial Using Tirzepatide to Help Adults With Type 1 Diabetes Automatically Control Their Blood Sugar (registry).

tirzepatide-gastric-emptying-t1d

Assessment: New 18-person Phase 1 T1D study uses acetaminophen pharmacokinetics to assess gastric emptying; not long-term HbA1c efficacy. Not yet recruiting; dates are estimates.

Registry: NCT07803744; NOT_YET_RECRUITING; updated 2026-09-04; enrollment 18 (ESTIMATED); results not posted.

Endpoint comparison: Pharmacokinetics (PK): Time of Maximum Observed Drug Concentration (Tmax) of Acetaminophen (Predose on Day 1 through 36 hours post dose); PK: Area Under the Concentration Versus Time Curve from Time Zero to Time t (AUC0-tlast) of Acetaminophen (Predose on Day 1 through 36 hours post dose); PK: Maximum Observed Drug Concentration (Cmax) of Acetaminophen (Predose on Day 1 through 36 hours post dose).

Sources for this record: A Study of Tirzepatide (LY3298176) in Participants With Type 1 Diabetes Mellitus and Overweight or Obesity (NCT07803744) (registry).

tirzepatide-type1-obesity-longterm

Registry: NCT06962280; ACTIVE_NOT_RECRUITING; updated 2026-02-17; enrollment 465 (ESTIMATED); results not posted.

Endpoint comparison: Change from Baseline in Hemoglobin A1c (HbA1c) (Baseline, Week 40).

Sources for this record: NCT06962280: Long-term tirzepatide safety in T1D with overweight or obesity (registry).

tirzepatide-type1-obesity-phase3

Registry: NCT06914895; ACTIVE_NOT_RECRUITING; updated 2026-05-12; enrollment 905 (ESTIMATED); results not posted.

Endpoint comparison: Change from Baseline in Hemoglobin A1c (HbA1c) (Baseline, Week 40).

Sources for this record: NCT06914895: Tirzepatide phase 3 in T1D with overweight or obesity (registry); SURPASS-T1D-1 trial page (manufacturer).

tn-07-oral-insulin

Registry: NCT00419562; COMPLETED; updated 2020-05-07; enrollment 560 (ACTUAL); results posted.

Endpoint comparison: Rate of Type 1 Diabetes Per Year Among Individuals in the Primary Stratum When Treated With Oral Inulin Versus Placebo (Metabolic and immunological tests were conducted every 6 months; participants were followed for a median of 2.7 years).

Sources for this record: Krischer JP, Schatz DA, Bundy B, Skyler JS, Greenbaum CJ; Writing Committee for the Type 1 Diabetes TrialNet Oral Insulin Study Group. Effect of Oral Insulin on Prevention of Diabetes in Relatives of Patients With Type 1 Diabetes: A Randomized Clinical Trial. JAMA (2017);318(19):1891–1902 (peer-reviewed); National Institute of Diabetes and Digestive and Kidney Diseases (TrialNet). Oral Insulin for Prevention of Diabetes in Relatives at Risk for Type 1 Diabetes Mellitus (TN07). ClinicalTrials.gov, NCT00419562 (registry); Oral Insulin Delay of Stage 3 Type 1 Diabetes Revisited in HLA DR4-DQ8 Participants in the TrialNet Oral Insulin Prevention Trial (TN07). (peer-reviewed); Source: 2664040 (peer-reviewed).

tn-10-teplizumab-prevention

Registry: NCT01030861; COMPLETED; updated 2020-08-05; enrollment 76 (ACTUAL); results posted.

Endpoint comparison: Rate of New Diabetes Per Year (During follow-up, median 745 days, range 74 to 2683).

Sources for this record: An Anti-CD3 Antibody, Teplizumab, in Relatives at Risk for Type 1 Diabetes. (peer-reviewed); U.S. Food and Drug Administration. FDA approves first drug that can delay onset of type 1 diabetes (FDA Update, Jan 1, 2023; original approval Nov 17, 2022) (regulatory); National Library of Medicine. AntiCD3 Mab (Teplizumab) For Prevention of Diabetes In Relatives At-Risk for Type 1 Diabetes Mellitus (NCT01030861). ClinicalTrials.gov (registry); Teplizumab improves and stabilizes beta cell function in antibody-positive high-risk individuals. (peer-reviewed); U.S. Food and Drug Administration. Drug Trials Snapshots: TZIELD. FDA (2022) (regulatory); NIH: Drug delays type 1 diabetes in people at high risk (community).

treg-rituximab-stage1

Registry: NCT06688331; RECRUITING; updated 2026-07-17; enrollment 150 (ESTIMATED); results not posted.

Endpoint comparison: % of participants in each group who are still in stage 1 type 1 diabetes mellitus, i.e., presence of autoantibodies and normoglycemia or in stage 2 type 1 diabetes mellitus, i.e., presence of autoantibodies, dysglycemia or stage 3 at the end of the trial (From day "0" (the day of administration of the first dose of Treg preparation) to the end of participation in the trial at month 60); Number of adverse events reported 1 year, 2 years after the first dose of Tregs and at the end of the trial comparing to control arms (From enrollment to the end of participation in the trial at month 60 (day "0" is the day of administration of the first dose of Treg preparation)).

Sources for this record: Treatment of Presymptomatic Stage 1 Type 1 Diabetes Pediatric Patients With Treg Cell Preparations and Anti-CD20 Antibody (registry).

trialnet-pathway-to-prevention

Registry: NCT00097292; RECRUITING; updated 2025-07-01; enrollment 75000 (ESTIMATED); results not posted.

Endpoint comparison: Development of type 1 diabetes (Monitoring is provided once or twice annually depending on risk level).

Sources for this record: NCT00097292: study record (registry).

trialnet-platform-teplizumab-atg

Assessment: September 9 registry andTrialNet ASCEND page now agree recruiting. Corrected target 60 and DPTRS 6-month surrogate endpoint, not observed clinical onset prevention.

Registry: NCT07216391; RECRUITING; updated 2026-09-09; enrollment 60 (ESTIMATED); results not posted.

Endpoint comparison: Change in DPTRS at six months (6 months after completion of study drug administration).

Sources for this record: NCT07216391: TrialNet platform: teplizumab vs low-dose ATG to delay stage-3 T1D (registry); ATG and Teplizumab Comparative Prevention Study (ASCEND T1D) (registry).

triple-therapy-t1dm

Registry: NCT03899402; ACTIVE_NOT_RECRUITING; updated 2026-05-29; enrollment 78 (ACTUAL); results not posted.

Endpoint comparison: Change in HbA1c following dapagliflozin (6 months).

Sources for this record: NCT03899402: Triple therapy in T1D (registry).

tuff-ipc-phase1-2a

Assessment: Current jRCT entry retrieved via indexed primary record: recruiting, last updated May 18; first enrollment January 27, 2026; three planned participants aged 18–65. Updated registry dates; no efficacy results.

Sources for this record: jRCT2063250055: TUFF-IPC autologous adipose-derived IPCs in T1D (registry).

twiist-pregnancy

Assessment: New 32-person device protocol, pregnant participants aged 18–45 in early gestation; no results. Registry primary nighttime range 60–140 differs standard pregnancy range 63–140; preserved exact study range.

Registry: NCT07808385; NOT_YET_RECRUITING; updated 2026-09-08; enrollment 32 (ESTIMATED); results not posted.

Endpoint comparison: Time in Range 60-140 mg/dL per night (30 weeks).

Sources for this record: Single Arm Intervention Trial of DEKA TWIIST TM Insulin Pump Utilizing Tidepool Loop Algorithm in Pregnant People With Pre-existing Type 1 Diabetes (NCT07808385) (registry).

ucbsc-islet-sequential-transplant

Assessment: Clarified rare monogenic immune-disorder population; does not represent ordinary autoimmune T1D.

Registry: NCT03835312; RECRUITING; updated 2026-03-17; enrollment 50 (ESTIMATED); results not posted.

Endpoint comparison: Concentration of serum C-peptide (from the completion of treatment to 3 months); Concentration of serum C-peptide (from the completion of treatment to 3 years).

Sources for this record: NCT03835312: Sequential cord-blood stem cells and islets in monogenic immunodeficiency T1D (registry).

unibe-ubloop-genesis

Registry: NCT07087340; COMPLETED; updated 2026-07-16; enrollment 6 (ACTUAL); results not posted.

Endpoint comparison: Percentage of time with the system functioning in closed-loop mode (10 hours); Failure rate of the HCL algorithm (10 hours); Failure rate of the communication with CGM device (10 hours); Failure rate of the communication with Insulin pump (10 hours); Failure rate of the user interface (BernSHELL) (10 hours); Failure rate of the web monitoring tool (DigiCARE) (10 hours).

Sources for this record: NCT07087340: UBLoop-Genesis early feasibility study (registry).

up421-hypoimmune-islets

Registry: NCT06239636; RECRUITING; updated 2024-12-11; enrollment 2 (ESTIMATED); results not posted.

Endpoint comparison: Safety as assessed by number of treatment related adverse events accoridng to CTCAE v 5.0 (12 months).

Sources for this record: First-in-human Safety Study of Hypoimmune Pancreatic Islet Transplantation in Adult Subjects With Type 1 Diabetes (registry); Survival of Transplanted Allogeneic Beta Cells with No Immunosuppression (peer-reviewed); Long-term follow-up of hypoimmune islet transplantation (peer-reviewed); Sana: publication of 14-month UP421 follow-up (manufacturer).

urli-minimed-780g-postmeal

Registry: NCT06600776; NOT_YET_RECRUITING; updated 2024-09-24; enrollment 50 (ESTIMATED); results not posted.

Endpoint comparison: Percentage of Time in Glucose Range (70-180 mg/dL) (Baseline to 4 weeks post-intervention).

Sources for this record: NCT06600776: Ultra-rapid lispro timing in MiniMed 780G (registry).

ust1d2-ustekinumab

Registry: NCT03941132; ACTIVE_NOT_RECRUITING; updated 2025-02-24; enrollment 66 (ESTIMATED); results not posted.

Endpoint comparison: Baseline change in 2-hour mixed meal-stimulated C-peptide AUC at week 52. (Week 52); Rate, frequency and severity of all adverse events including; hypoglycemic episodes; injection reactions; hypersensitivity reactions; evidence of infection and posterior leukoencephalopathy syndrome. (Week 52).

Sources for this record: Clinical Phase II/III Trial of Ustekinumab to Treat Type 1 Diabetes (UST1D2) (registry).

ustekid-ustekinumab

Assessment: Primary NatureMedicine abstract/NIHR report checked against72 randomized and62analyzed populations;49% relative C-peptide effect. Direct ISRCTN retrieval redirected to holding page, so latest registry state could not independently be refreshed.

Sources for this record: Ustekinumab for type 1 diabetes in adolescents (peer-reviewed); ISRCTN14274380: Ustekinumab in adolescents with recent-onset type 1 diabetes (registry).

vc-01-viacyte-encapsulated

Registry: NCT02239354; TERMINATED; updated 2022-03-24; enrollment 19 (ACTUAL); results posted.

Endpoint comparison: Number of Adverse Events Reported During the Study. (Thru the Month 24 Visit); Change in C-peptide (Baseline to the Month 6 Visit).

Sources for this record: NCT02239354: study record (registry); CIRM: VC-01 clinical trial Year 4 progress report (community); ViaCyte: two-year STEP ONE data presented at ADA 2018 (manufacturer).

vctx210-crispr-encapsulated

Registry: NCT05210530; COMPLETED; updated 2023-06-26; enrollment 7 (ACTUAL); results not posted.

Endpoint comparison: Incidence of adverse events with causality related to VCTX210A units and/or the surgical procedures required to implant and explant the VCTX210A units. (From implantation up to 6 months post implantation).

Sources for this record: NCT05210530: study record (registry); CRISPR Therapeutics and ViaCyte: first VCTX210 participant dosed (manufacturer).

vctx211-crispr-hypoimmune

Registry: NCT05565248; TERMINATED; updated 2026-05-07; enrollment 5 (ACTUAL); results not posted.

Endpoint comparison: Incidence of adverse events with causality related to VCTX211 units, the surgical procedures and/or medical interventions required to implant and explant the VCTX211 units. (From implantation up to 12 months post implantation); Assess the clinical efficacy of VCTX211 units via evaluation of C-peptide increase from the baseline. (From implantation up to 12 months post implantation).

Sources for this record: NCT05565248: study record (registry); CRISPR Therapeutics: January 2026 priorities and CTX211 update (manufacturer).

verapamil-children-egypt

Assessment: Newly registered Egyptian recruiting Phase 2/3 trial, target 70, ages 10–18 within six weeks of diagnosis, six-month stimulated C-peptide; no results.

Registry: NCT07804849; RECRUITING; updated 2026-09-04; enrollment 70 (ESTIMATED); results not posted.

Endpoint comparison: Peak stimulated serum C-peptide concentration after mixed meal tolerance test (24 weeks).

Sources for this record: Oral Verapamil Among Newly Diagnosed Children and Adolescents With Type 1 Diabetes (NCT07804849) (registry).

verapamil-children-recent-onset

Registry: NCT07199946; RECRUITING; updated 2025-09-30; enrollment 36 (ESTIMATED); results not posted.

Endpoint comparison: Change in C-peptide AUCmean 0-120 min) during an MMTT from baseline to month 24. (24 months); Number of participants with treatment-related adverse events as assessed by CTCAE v4.0". (24 months).

Sources for this record: NCT07199946: Verapamil to preserve residual insulin secretion in children (registry).

verapamil-newonset

Registry: NCT04545151; COMPLETED; updated 2026-05-20; enrollment 136 (ACTUAL); results not posted.

Endpoint comparison: Area under the stimulated C-peptide response curve (At 12 months).

Sources for this record: NCT04545151: study record (registry); EASD: Ver-A-T1D conference results, September 2025 (conference); Ver-A-T1D randomized trial protocol (peer-reviewed).

vx-264-encapsulated-islets

Assessment: Separated discontinued product from active follow-up of 7 participants; September 10 registry date and March 2027 estimate. Removed unsupported mechanistic explanation for failure and broad safety certainty. Company outcome report is not a detailed participant-level publication.

Registry: NCT05791201; ACTIVE_NOT_RECRUITING; updated 2026-09-10; enrollment 7 (ACTUAL); results not posted.

Endpoint comparison: Part A and Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (From Day 1 up to 24 months); Part B: Change in Peak C-peptide during Mixed-Meal Tolerance Test (MMTT) (From Baseline and at Day 90).

Sources for this record: Vertex Pharmaceuticals. Vertex Doses First Patient in Phase 1/2 Trial of VX-264 in Type 1 Diabetes (coverage). CGTLive (2023) (news); Masson G. Vertex drops cell-device diabetes combo over poor phase 1 results. Fierce Biotech (2025) (news); ClinicalTrials.gov. A Study to Evaluate the Safety, Tolerability, and Efficacy of VX-264 in Subjects With Type 1 Diabetes Mellitus (NCT05791201). U.S. National Library of Medicine (accessed 2026) (registry); Vertex Pharmaceuticals. Vertex Announces Program Updates for Type 1 Diabetes Portfolio. Vertex Pharmaceuticals (2025) (manufacturer); Advances in Cell Replacement Therapies for Diabetes. (peer-reviewed).

vx-880-kidney-transplant-phase3

Registry: NCT06832410; RECRUITING; updated 2026-03-23; enrollment 10 (ESTIMATED); results not posted.

Endpoint comparison: Proportion of Participants who are Insulin Independent (At 1 year After VX-880 infusion).

Sources for this record: A Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of VX-880 in Subjects With Type 1 Diabetes With a Kidney Transplant (registry); Stem Cell-Derived, Fully Differentiated Islets for Type 1 Diabetes (peer-reviewed).

vx-880-zimislecel

Assessment: Compared current master protocol, NEJM primary report and Vertex/SEC update. AddedVX-017 Part D safety and57 estimated total participants. Separated VX-880: 14 followed / 12 full-dose outcomes from absentVX-017 outcomes; preserved interim, nonprespecified analyses and serious harms. No invented blood-type restriction, dosing milestone or efficacy.

Registry: NCT04786262; RECRUITING; updated 2026-09-01; enrollment 57 (ESTIMATED); results not posted.

Endpoint comparison: Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) (From VX-880 infusion to end of study (at least 5 years)); Parts B and C: Proportion of Participants who are Insulin Independent with Absence of Severe Hypoglycemic Events (SHEs) (1 year after achieving insulin independence (following VX-880 infusion)); Part D: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) (From VX-017 infusion to end of study (at least 5 years)).

Sources for this record: FORWARD: VX-880 and VX-017 (NCT04786262) (registry); Stem Cell-Derived, Fully Differentiated Islets for Type 1 Diabetes (peer-reviewed); Vertex second-quarter 2026 financial results (manufacturer).

wave-t1d-atg-adalimumab-verapamil

Registry: NCT07061574; RECRUITING; updated 2026-09-02; enrollment 120 (ESTIMATED); results not posted.

Endpoint comparison: Stimulated C-peptide AUC (Week 104).

Sources for this record: WAVE T1D: A Randomized Phase 1/2 Trial of Low Dose ATG With Subsequent Adalimumab or Verapamil in New Onset Type 1 Diabetes (NCT07061574) (registry).

zt01-nocturnal-hypoglycemia

Registry: NCT05762107; RECRUITING; updated 2026-04-29; enrollment 186 (ESTIMATED); results not posted.

Endpoint comparison: Incidence of nocturnal hypoglycemia (During each 28 day treatment period).

Sources for this record: NCT05762107: ZT-01 to prevent nocturnal hypoglycemia (registry).

encellin-enc-201-encrt

Assessment: Reconciled the July sponsor update with the older registry: seven enrolled versus ten estimated. Interim explant findings remain distinct from clinical efficacy. January viable-islet findings were limited to the initial evaluated explant. Passed estimated completion is not a readout.

Sources: Current registry; July sponsor release hosted by ISSCR.

Limits: Open-label safety study; no posted registry results or demonstrated insulin independence.

anti-il21-liraglutide-newonset

Assessment: Added historical trial from the current registry and primary publication; distinguished enrollment/analysis populations, study endpoints, benefit limits and program status. Of 308 randomized participants, 307 received treatment and entered the full analysis and safety sets. C-peptide declined by 10% with combination treatment versus 39% with placebo at week 54 (estimated treatment ratio 1.48, 95% CI 1.16–1.89; P=0.0017). Monotherapy comparisons were not significant. Effects diminished after treatment stopped.

Sources: A Clinical Proof-of-principle Trial in Adult Subjects With Newly Diagnosed Type 1 Diabetes Mellitus Investigating the Effect of NNC0114-0006 and Liraglutide on Preservation of Beta-cell Function; Anti-interleukin-21 antibody and liraglutide for the preservation of β-cell function in adults with recent-onset type 1 diabetes: a randomised, double-blind, placebo-controlled, phase 2 trial; Novo Nordisk financial results for the first nine months of 2020.

Limits: Editorial source comparison, not independent clinical certification. A completed trial is not a currently recruiting option.

dfmo-phase1-newonset

Assessment: Added historical trial from the current registry and primary publication; distinguished enrollment/analysis populations, study endpoints, benefit limits and program status. The 2023 paper reports 41 participants randomized approximately 3:1 and says the primary safety/tolerability endpoint was met. Higher-dose C-peptide findings were exploratory; this small study does not establish clinical efficacy. The registry has no posted results tables.

Sources: DFMO in Children With Type 1 Diabetes; Inhibition of polyamine biosynthesis preserves β cell function in type 1 diabetes.

Limits: Editorial source comparison, not independent clinical certification. A completed trial is not a currently recruiting option.

rezpegaldesleukin-newonset

Additional current-status correction.

The rezpegaldesleukin-newonset record was additionally compared with the 8 September 2026 registry update: 15 listed sites, 14 US recruiting and one Canadian not yet recruiting. Current age-cohort openings are not established by the registry. Removed the stale assertion that children cannot yet join and the unsupported claim that a shared C-peptide endpoint makes treatments directly comparable.