Full dated editorial ledger. Review depth and source access vary by record; these notes are not independent clinical certification. 59 records appear in this report.
Baseline trial evidence review: M–S
16 September 2026. GPT-Astra (medium), assisting GPT-Astra (xhigh). AI editorial/source audit; not clinical validation.
Scope:59 baseline records, excluding McGill FCL and PANORAMA, plus parent-added trials. Summaries, registered endpoints and substantive eligibility were read against current ClinicalTrials.gov cached protocols. Historical primary abstracts were retrieved via Europe PMC/PubMed; selected publisher and sponsor sources were consulted directly. Missing abstracts are recorded explicitly; this is not full-text verification of every historical citation. Registry eligibility does not prove local recruitment, actual dosing or efficacy. Estimated counts/dates are not actual results.
Priority corrections: Sernova combined-graft confounding; RGB5088 optional rather than mandatory prior transplants; NNC0363 false first-human claim; Omnipod241publication vs240registry and extension adverse events; OHSU posted primary results; PROTECT new per-protocol report distinguished from originalITT; SAFEGUARD PartC; semaglutide2×3design and direct trial–item links.
matin2-sequential-immune-tolerance
Outcome: No additional discrepancy identified in the reviewed summary/design/endpoint and eligibility fields. Existing sponsor or historical claims are not all independently certified by this protocol comparison.
Registry: NCT07610213. Endpoint reviewed: Change in Stimulated C-peptide AUC (Baseline, 6, 12, and 24 months). Eligibility reviewed: Age 18 Years to 45 Years; diagnosis/stage, prior therapy and key biomarker criteria compared with site summary. Full exclusions remain in the registry. Literature access limit: No usable primary abstract was independently recovered for this record in this pass. Current registry protocol was the main source; detailed sponsor or conference data remain dependent on the cited source and were not fully reverified.
medtronic-implantable-pump-miips
Outcome: Replaced vague eligibility with substantive registry age, diagnosis, treatment and key biomarker restrictions; no efficacy inferred.
Registry: NCT06739811. Endpoint reviewed: Refill accuracy of MIIPS 2020 (6 months). Eligibility reviewed: Age 18 Years to unspecified; diagnosis/stage, prior therapy and key biomarker criteria compared with site summary. Full exclusions remain in the registry. Literature access limit: No usable primary abstract was independently recovered for this record in this pass. Current registry protocol was the main source; detailed sponsor or conference data remain dependent on the cited source and were not fully reverified.
medtrum-apgo-renew
Outcome: No additional discrepancy identified in the reviewed summary/design/endpoint and eligibility fields. Existing sponsor or historical claims are not all independently certified by this protocol comparison.
Registry: NCT07320495. Endpoint reviewed: Changes in glycated haemoglobin (HbA1c) (Up to 24 months); Changes in percentage of time in target ranges 3,9-10,0 mmol/L (70-180 mg/dl) (Up to 24 months). Eligibility reviewed: Age 18 Years to unspecified; diagnosis/stage, prior therapy and key biomarker criteria compared with site summary. Full exclusions remain in the registry. Literature access limit: No usable primary abstract was independently recovered for this record in this pass. Current registry protocol was the main source; detailed sponsor or conference data remain dependent on the cited source and were not fully reverified.
minimed-670g-pivotal
Outcome: No additional discrepancy identified in the reviewed summary/design/endpoint and eligibility fields. Existing sponsor or historical claims are not all independently certified by this protocol comparison.
Registry: NCT02463097. Endpoint reviewed: Change in A1C (Baseline and 3 months). Eligibility reviewed: Age 14 Years to 75 Years; diagnosis/stage, prior therapy and key biomarker criteria compared with site summary. Full exclusions remain in the registry. Additional source access: Glucose Outcomes with the In-Home Use of a Hybrid Closed-Loop Insulin Delivery System in Adolescents and Adults with Type 1 Diabetes.; Safety Evaluation of the MiniMed 670G System in Children 7-13 Years of Age with Type 1 Diabetes..
minimed-780g-gastroparesis
Outcome: Replaced vague eligibility with substantive registry age, diagnosis, treatment and key biomarker restrictions; no efficacy inferred.
Registry: NCT07287943. Endpoint reviewed: Time in Range (70-180 mg/dL) (Baseline to 3 months). Eligibility reviewed: Age 18 Years to unspecified; diagnosis/stage, prior therapy and key biomarker criteria compared with site summary. Full exclusions remain in the registry. Literature access limit: No usable primary abstract was independently recovered for this record in this pass. Current registry protocol was the main source; detailed sponsor or conference data remain dependent on the cited source and were not fully reverified.
minimed-fit-payload-wear
Outcome: No additional discrepancy identified in the reviewed summary/design/endpoint and eligibility fields. Existing sponsor or historical claims are not all independently certified by this protocol comparison.
Registry: NCT07408141. Endpoint reviewed: The MiniMed Fit Payload success rate at the end of Day 5. (5 Days). Eligibility reviewed: Age 18 Years to unspecified; diagnosis/stage, prior therapy and key biomarker criteria compared with site summary. Full exclusions remain in the registry. Literature access limit: No usable primary abstract was independently recovered for this record in this pass. Current registry protocol was the main source; detailed sponsor or conference data remain dependent on the cited source and were not fully reverified.
minimed-fit-pediatric-wear
Outcome: No additional discrepancy identified in the reviewed summary/design/endpoint and eligibility fields. Existing sponsor or historical claims are not all independently certified by this protocol comparison.
Registry: NCT07675161. Endpoint reviewed: Summary of device survival (7 Days). Eligibility reviewed: Age 7 Years to 17 Years; diagnosis/stage, prior therapy and key biomarker criteria compared with site summary. Full exclusions remain in the registry. Literature access limit: No usable primary abstract was independently recovered for this record in this pass. Current registry protocol was the main source; detailed sponsor or conference data remain dependent on the cited source and were not fully reverified.
minimed-nmx8-gateway
Outcome: Added current active-not-recruiting status, actual389 enrollment and estimated January2027 completion; product clearance is not trial outcome data.
Registry: NCT07228117. Endpoint reviewed: Study Arm 1: Percent of Time in Range (TIR 70-180 mg/dL) (Throughout the study period, approximately 90 days.); Study Arm 1: Percent of Time in Hypoglycemia (< 70 mg/dL) (Throughout the study period, approximately 90 days.); Study Arm 2: Percent of Time in Range (TIR 70-180 mg/dL) (Throughout the study period, approximately 90 days.); Study Arm 2: Percent of Time in Hypoglycemia (< 70 mg/dL) (Throughout the study period, approximately 90 days.); Study Arm 3: Percent of Time in Range (TIR 70-180 mg/dL) (Throughout the study period, approximately 90 days.); Study Arm 3: Percent of Time in Hypoglycemia (< 70 mg/dL) (Throughout the study period, approximately 90 days.). Eligibility reviewed: Age 7 Years to 85 Years; diagnosis/stage, prior therapy and key biomarker criteria compared with site summary. Full exclusions remain in the registry. Literature access limit: No usable primary abstract was independently recovered for this record in this pass. Current registry protocol was the main source; detailed sponsor or conference data remain dependent on the cited source and were not fully reverified.
minimed-nmx8-nexus
Outcome: Replaced vague eligibility with substantive registry age, diagnosis, treatment and key biomarker restrictions; no efficacy inferred.
Registry: NCT07227805. Endpoint reviewed: Primary Endpoint (During the 12-week study phase). Eligibility reviewed: Age 2 Years to unspecified; diagnosis/stage, prior therapy and key biomarker criteria compared with site summary. Full exclusions remain in the registry. Literature access limit: No usable primary abstract was independently recovered for this record in this pass. Current registry protocol was the main source; detailed sponsor or conference data remain dependent on the cited source and were not fully reverified.
mtx228-adaptive-t1d
Outcome: Replaced vague eligibility with substantive registry age, diagnosis, treatment and key biomarker restrictions; no efficacy inferred.
Registry: NCT06474598. Endpoint reviewed: Change in AUC C-peptide (Days 0 and 84); Dose selection for phase IIb study (Days 0 and 84). Eligibility reviewed: Age 18 Years to 65 Years; diagnosis/stage, prior therapy and key biomarker criteria compared with site summary. Full exclusions remain in the registry. Literature access limit: No usable primary abstract was independently recovered for this record in this pass. Current registry protocol was the main source; detailed sponsor or conference data remain dependent on the cited source and were not fully reverified.
next-gen-aid-algorithm-adults
Outcome: No additional discrepancy identified in the reviewed summary/design/endpoint and eligibility fields. Existing sponsor or historical claims are not all independently certified by this protocol comparison.
Registry: NCT07593625. Endpoint reviewed: Percentage of time <54 mg/dL (72-hour Omnipod M Hotel Period); Percentage of time <70 mg/dL (72-hour Omnipod M Hotel Period); Percentage of time >180 mg/dL (72-hour Omnipod M Hotel Period); Percentage of time <54 mg/dL (4-week Omnipod M outpatient); Percentage of time <54 mg/dL (Final 3 weeks of Omnipod S outpatient); Percentage of time <70 mg/dL (4-week Omnipod M outpatient); Percentage of time <70 mg/dL (Final 3-weeks Omnipod S outpatient); Percentage of time >180 mg/dL (4-week Omnipod M outpatient); Percentage of time >180 mg/dL (Final 3-weeks Omnipod S outpatient). Eligibility reviewed: Age 2 Years to 70 Years; diagnosis/stage, prior therapy and key biomarker criteria compared with site summary. Full exclusions remain in the registry. Literature access limit: No usable primary abstract was independently recovered for this record in this pass. Current registry protocol was the main source; detailed sponsor or conference data remain dependent on the cited source and were not fully reverified.
nnc0194-0499-semaglutide-t1d
Outcome: No additional discrepancy identified in the reviewed summary/design/endpoint and eligibility fields. Existing sponsor or historical claims are not all independently certified by this protocol comparison.
Registry: NCT07087795. Endpoint reviewed: Part A: Change in time in range (TIR) 3.9-10.0 mmol/L (70-80 mg/dL) (From baseline (day -14 - -1) to day 36-49 / day 106-119); Part B: Change in time in range (TIR) 3.9-10.0 mmol/L (70-80 mg/dL) (From baseline (day -14 - -1) to day 92-105 / day 162-175). Eligibility reviewed: Age 18 Years to 64 Years; diagnosis/stage, prior therapy and key biomarker criteria compared with site summary. Full exclusions remain in the registry. Literature access limit: No usable primary abstract was independently recovered for this record in this pass. Current registry protocol was the main source; detailed sponsor or conference data remain dependent on the cited source and were not fully reverified.
nnc0363-1063-t1d-clamp
Outcome: Removed speculative strongest missing-datapoint claim; retained controlled clamp endpoint and no-results distinction.
Registry: NCT07305805. Endpoint reviewed: AUC, GIR,SS: Area under the glucose infusion rate-time curve at steady state (Visit 2 and 3: Day 2 and 3). Eligibility reviewed: Age 18 Years to 64 Years; diagnosis/stage, prior therapy and key biomarker criteria compared with site summary. Full exclusions remain in the registry. Literature access limit: No usable primary abstract was independently recovered for this record in this pass. Current registry protocol was the main source; detailed sponsor or conference data remain dependent on the cited source and were not fully reverified.
nnc0363-1063-t1d-phase1
Outcome: Removed false first-human class milestone using earlier primary MK2640 humanT1D trial (PMID30125349).
Registry: NCT06685185. Endpoint reviewed: Part 1 SAD: Number of adverse events (From investigational medicinal product (IMP) administration (day 1) until end of study visit (day 8)); Part 2 PoP: CL/F,I1063,SD- Apparent serum clearance of NNC0363-1063 after a single dose (From IMP administration at day 1 up to 7 days); Part 3 Meal test: AUC,PG,meal: Area under the plasma glucose concentration-time curve at steady state (At day 2 of visit 2 and visit 3 after initiation of meal test). Eligibility reviewed: Age 18 Years to 64 Years; diagnosis/stage, prior therapy and key biomarker criteria compared with site summary. Full exclusions remain in the registry. Additional source access: Earlier MK-2640 human primary study.
nomad-no-meal-announcement
Outcome: No additional discrepancy identified in the reviewed summary/design/endpoint and eligibility fields. Existing sponsor or historical claims are not all independently certified by this protocol comparison.
Registry: NCT07758647. Endpoint reviewed: Percentage of time in target glucose range during the 4 hours following unannounced meal challenges (During the final 2 weeks of each 4-week intervention period (following the run-in phase).). Eligibility reviewed: Age 18 Years to unspecified; diagnosis/stage, prior therapy and key biomarker criteria compared with site summary. Full exclusions remain in the registry. Literature access limit: No usable primary abstract was independently recovered for this record in this pass. Current registry protocol was the main source; detailed sponsor or conference data remain dependent on the cited source and were not fully reverified.
ohsu-insulin-pramlintide-mpc
Outcome: Reviewed actualpostedresults, added31participant firstmeal primary adjustedAUC benefit and nonsignificant TIR, distinguished adjusted vsraw means and acute vsfree-living; removedroadmaplinks.
Registry: NCT06422325. Endpoint reviewed: Incremental Area Under the Curve of Postprandial Glucose Following the First Meal (6 hours following first meal); Percent of Time With Sensed Glucose Between 70 - 180 mg/dl Following First Meal (6 hours following first meal). Eligibility reviewed: Age 18 Years to 70 Years; diagnosis/stage, prior therapy and key biomarker criteria compared with site summary. Full exclusions remain in the registry. Results access: Actual posted primary/secondary outcome tables were read, including denominator, group labels and estimates. No peer-reviewed status is inferred from posting.
omnipod-5-pivotal
Outcome: Distinguished241 publicationparticipants from240registry, added infusion-site causeofDKA and extension7severelows/1DKA; checkedprimaryabstracts.
Registry: NCT04196140. Endpoint reviewed: Incidence Rate of Severe Hypoglycemia (Events Per Person Months) (Phase 2 hybrid closed-loop (94 days)); Incidence Rate of Diabetic Ketoacidosis (DKA) (Events Per Person Months) (Phase 2 hybrid closed-loop (94 days)); Glycated Hemoglobin (A1C) (6 weeks continuous Phase 2 participation compared to baseline); Time in Range 70-180 mg/dL (Phase 2 hybrid closed-loop (94 days) compared to Phase 1 standard therapy (14 days)). Eligibility reviewed: Age 6 Years to 70 Years; diagnosis/stage, prior therapy and key biomarker criteria compared with site summary. Full exclusions remain in the registry. Additional source access: Multicenter Trial of a Tubeless, On-Body Automated Insulin Delivery System With Customizable Glycemic Targets in Pediatric and Adult Participants With Type 1 Diabetes.; Two Years with a Tubeless Automated Insulin Delivery System: A Single-Arm Multicenter Trial in Children, Adolescents, and Adults with Type 1 Diabetes.; Psychosocial outcomes with the Omnipod® 5 Automated Insulin Delivery System in caregivers of very young children with type 1 diabetes.; Extension primary abstract.
omnipod-5-preschool
Outcome: Primary13week and extensionabstracts agree with stated outcomes; no pivotal severe lows/DKA versus1each extension. Registry exclusion forDKA hasexceptions, clarified.
Registry: NCT04476472. Endpoint reviewed: Incidence Rate of Severe Hypoglycemia (Events Per Person Months) (Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days)); Incidence Rate of Diabetic Ketoacidosis (DKA) (Events Per Person Months) (Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days)); Glycated Hemoglobin (A1C) (Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (180 days, 270 days, 360 days, and 450 days) compared to baseline); Time in Range 70-180 mg/dL (Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (450 days) compared to Phase 1 standard therapy (14 days)). Eligibility reviewed: Age 2 Years to 5 Years; diagnosis/stage, prior therapy and key biomarker criteria compared with site summary. Full exclusions remain in the registry. Additional source access: Pivotal primary abstract; Extension primary abstract.
omnipod-6-strive-2
Outcome: Added key HbA1c, CGM and fewer-than4boluses inclusion criteria from currentregistry.
Registry: NCT07579702. Endpoint reviewed: Time in Range 70-180 mg/dL (13 weeks); Time <54 mg/dL (13 weeks); Time <70 mg/dL (13 weeks); Time >180 mg/dL (13 weeks); Time in Range 70-140 mg/dL (13 weeks); HbA1c (13 weeks); Mean sensor glucose (13 weeks); Time >250 mg/dL (13 weeks). Eligibility reviewed: Age 14 Years to 75 Years; diagnosis/stage, prior therapy and key biomarker criteria compared with site summary. Full exclusions remain in the registry. Literature access limit: No usable primary abstract was independently recovered for this record in this pass. Current registry protocol was the main source; detailed sponsor or conference data remain dependent on the cited source and were not fully reverified.
omnipod-strive-smartadjust-2
Outcome: Removed roadmap links and false universal claim about current mealautomation; sponsorconference comparison remains clearly provisional, not period3 evidence.
Registry: NCT06865989. Endpoint reviewed: Percent of time in range <54 mg/dL (non-inferiority margin of 0.75%) (End of Period 2 (Day 56) compared to Baseline); Percent of time in range <70 mg/dL (non-inferiority margin of 3.0%) (End of Period 2 (Day 56) compared to Baseline); Percent of time in range 70-180 mg/dL (non-inferiority margin of 3.0%) (End of Period 2 (Day 56) compared to Baseline); Mean Glucose (non-inferiority margin of 8 mg/dL) (End of Period 2 (Day 56) compared to Baseline). Eligibility reviewed: Age 2 Years to 70 Years; diagnosis/stage, prior therapy and key biomarker criteria compared with site summary. Full exclusions remain in the registry. Literature access limit: No usable primary abstract was independently recovered for this record in this pass. Current registry protocol was the main source; detailed sponsor or conference data remain dependent on the cited source and were not fully reverified.
open-source-aid-china
Outcome: Replaced vagueeligibility; flagged header3–75 vsprose allages discrepancy ratherthan guessing.
Registry: NCT06081231. Endpoint reviewed: proportion of time spent in the target glucose range (baseline(at least 2 weeks before the start of APS), and 3 months,6 months, 9 months, 12 months, and following period after the start of APS). Eligibility reviewed: Age 3 Years to 75 Years; diagnosis/stage, prior therapy and key biomarker criteria compared with site summary. Full exclusions remain in the registry. Literature access limit: No usable primary abstract was independently recovered for this record in this pass. Current registry protocol was the main source; detailed sponsor or conference data remain dependent on the cited source and were not fully reverified.
opf-310-porcine-islets
Outcome: No additional discrepancy identified in the reviewed summary/design/endpoint and eligibility fields. Existing sponsor or historical claims are not all independently certified by this protocol comparison.
Registry: NCT06575426. Endpoint reviewed: Percentage of Subjects Reaching the Efficacy Goal (One year after transplant). Eligibility reviewed: Age 35 Years to 70 Years; diagnosis/stage, prior therapy and key biomarker criteria compared with site summary. Full exclusions remain in the registry. Literature access limit: No usable primary abstract was independently recovered for this record in this pass. Current registry protocol was the main source; detailed sponsor or conference data remain dependent on the cited source and were not fully reverified.
opt101-phase1b
Outcome: Registry-posted Cpeptide(.03/.07/.16ng/mL),HbA1c(.53/.12/.06) andrelatedAE(1/1/0) tables checked by group; no efficacy established. Some registry fields repeat values/labels inconsistently; not corrected by inference.
Registry: NCT05428943. Endpoint reviewed: Number of Treatment-related AE's as Assessed by CTCAE v4.0 (42 days). Eligibility reviewed: Age 18 Years to 60 Years; diagnosis/stage, prior therapy and key biomarker criteria compared with site summary. Full exclusions remain in the registry. Results access: Actual posted primary/secondary outcome tables were read, including denominator, group labels and estimates. No peer-reviewed status is inferred from posting.
opt101-phase2
Outcome: No additional discrepancy identified in the reviewed summary/design/endpoint and eligibility fields. Existing sponsor or historical claims are not all independently certified by this protocol comparison.
Registry: NCT06964087. Endpoint reviewed: Change in C-peptide (ng/mL) (48-week). Eligibility reviewed: Age 18 Years to 50 Years; diagnosis/stage, prior therapy and key biomarker criteria compared with site summary. Full exclusions remain in the registry. Literature access limit: No usable primary abstract was independently recovered for this record in this pass. Current registry protocol was the main source; detailed sponsor or conference data remain dependent on the cited source and were not fully reverified.
pediatric-primary-care-screening
Outcome: No additional discrepancy identified in the reviewed summary/design/endpoint and eligibility fields. Existing sponsor or historical claims are not all independently certified by this protocol comparison.
Registry: NCT07612475. Endpoint reviewed: Feasibility (Clinician Perspective) (Towards the end of the study (approximately months 12-15)); Acceptability (Parent Perspective) (Throughout study period (15 months)); Acceptability (Clinician Perspective) (Towards the end of the study (approximately months 12-15)); Appropriateness (Parent Perspective) (Throughout study period (15 months)); Appropriateness (Clinician Perspective) (Towards the end of the study (approximately months 12-15)). Eligibility reviewed: Age 1 Year to unspecified; diagnosis/stage, prior therapy and key biomarker criteria compared with site summary. Full exclusions remain in the registry. Literature access limit: No usable primary abstract was independently recovered for this record in this pass. Current registry protocol was the main source; detailed sponsor or conference data remain dependent on the cited source and were not fully reverified.
pipeptoldc-vaccine
Outcome: Replaced vague eligibility with substantive registry age, diagnosis, treatment and key biomarker restrictions; no efficacy inferred.
Registry: NCT04590872. Endpoint reviewed: Incidence of adverse events (Up to 2 years); Apheresis duration (up to 2 years); Number of CD14+ monocytes (up to 2 years); TolDC recovery after culture (up to 2 years); Number of successful manufactured products (Up to 2 years). Eligibility reviewed: Age 18 Years to 45 Years; diagnosis/stage, prior therapy and key biomarker criteria compared with site summary. Full exclusions remain in the registry. Literature access limit: No usable primary abstract was independently recovered for this record in this pass. Current registry protocol was the main source; detailed sponsor or conference data remain dependent on the cited source and were not fully reverified.
pku-ipsc-derived-islet-cells
Outcome: Removed inference that registry proves nobody dosed; distinguished estimated enrollment, mixeddiabetes eligibility and no established drug-free protocol.
Registry: NCT07464119. Endpoint reviewed: Adverse events (From enrollment to month 6). Eligibility reviewed: Age 18 Years to unspecified; diagnosis/stage, prior therapy and key biomarker criteria compared with site summary. Full exclusions remain in the registry. Additional source access: Transplantation of chemically induced pluripotent stem-cell-derived islets under abdominal anterior rectus sheath in a type 1 diabetes patient.; Illuminating the future of diabetes treatment: Autologous CiPSC-derived islets take center stage..
platform-golimumab-stage1
Outcome: Corrected direct item relationships; shared class or background is insufficient.
Registry: NCT07683026. Endpoint reviewed: Progression to Dysglycemia (From randomization to confirmed dysglycemia or clinical diagnosis of T1D, approximately 6 years from the first participant enrolled.). Eligibility reviewed: Age 2 Years to 44 Years; diagnosis/stage, prior therapy and key biomarker criteria compared with site summary. Full exclusions remain in the registry. Additional source access: Golimumab and Beta-Cell Function in Youth with New-Onset Type 1 Diabetes..
portal-insulin-ip-clamp
Outcome: No additional discrepancy identified in the reviewed summary/design/endpoint and eligibility fields. Existing sponsor or historical claims are not all independently certified by this protocol comparison.
Registry: NCT07341373. Endpoint reviewed: Safety: Incidence of adverse events (From enrollment until the follow-up visit, an average of 2 months); Safety: Change from baseline in systolic and diastolic blood pressure (Will be measured at 2 times, first within 4 hours before drug administration (Pre-clamp) and then after 12 hours of drug administration (post-clamp)); Safety: Change from baseline in temperature (Will be measured at 2 times, first within 4 hours before drug administration (Pre-clamp) and then after 12 hours of drug administration (post-clamp)); Safety: Change from baseline in respiratory rate (Will be measured at 2 times, first within 4 hours before drug administration (Pre-clamp) and then after 12 hours of drug administration (post-clamp)); Safety: Change from baseline in heart rate (Will be measured at 2 times, first within 4 hours before drug administration (Pre-clamp) and then after 12 hours of drug administration (post-clamp)); Safety: Change from baseline in 12-lead electrocardiogram (ECG) parameters (Pre-dose and after the end of PK-sampling (720 minutes post-dose)); Safety: Incidence and severity of clinical findings on physical examination (Pre-dose and after the end of PK-sampling (720 minutes post-dose)); Tolerability: Pain assessments per Visual Analogue Scale (VAS) (10 min and 1 hour post-dosing); Tolerability: Change in Interleukin 6 [IL-6] levels (Blood samples will be taken immediately before dosing, 2 hours after dosing, and with the last PK sample (720 minutes after dosing)); Tolerability: Change in tumor necrosis factor [TNF-α] levels (Blood samples will be taken immediately before dosing, 2 hours after dosing, and with the last PK sample (720 minutes after dosing)); Tolerability: Change in high sensitivity C-reactive protein [hsCRP] levels (Blood samples will be taken immediately before dosing, 2 hours after dosing, and with the last PK sample (720 minutes after dosing)); Pharmacokinetic: Area under the insulin concentration-time curve (AUC) (From the time of dose (time 0) until 12 hours post-dose (AUCIns,0-12h)); Pharmacokinetic: Maximum insulin concentration (Cmax) (Over 12 hours post-dosing); Pharmacokinetic: Time to maximum insulin concentration (Tmax) (Over 12 hours post-dosing); Glucodynamic: Area under the glucose infusion rate (GIR) time curve (From the time of dose (time 0) until 12 hours post-dose (AUCGIR,0-12h)); Glucodynamic: Maximum GIR (GIRmax) (Over 12 hours post-dosing); Glucodynamic: Time to maximum GIR (TGIRmax) (Over 12 hours post-dosing). Eligibility reviewed: Age 18 Years to 60 Years; diagnosis/stage, prior therapy and key biomarker criteria compared with site summary. Full exclusions remain in the registry. Literature access limit: No usable primary abstract was independently recovered for this record in this pass. Current registry protocol was the main source; detailed sponsor or conference data remain dependent on the cited source and were not fully reverified.
precision-atg-verapamil-wave
Outcome: No additional discrepancy identified in the reviewed summary/design/endpoint and eligibility fields. Existing sponsor or historical claims are not all independently certified by this protocol comparison.
Registry: NCT06455319. Endpoint reviewed: AUC C-peptide between ATG and placebo values (12 Months); Change in 2-hr MMTT AUC C-peptide (6 months). Eligibility reviewed: Age 6 Years to 35 Years; diagnosis/stage, prior therapy and key biomarker criteria compared with site summary. Full exclusions remain in the registry. Literature access limit: No usable primary abstract was independently recovered for this record in this pass. Current registry protocol was the main source; detailed sponsor or conference data remain dependent on the cited source and were not fully reverified.
precision-t1d-cardiorenal-platform
Outcome: No additional discrepancy identified in the reviewed summary/design/endpoint and eligibility fields. Existing sponsor or historical claims are not all independently certified by this protocol comparison.
Registry: NCT07594145. Endpoint reviewed: Markers of Renal Health [Safety and Tolerability] (26 weeks); Markes of Cardio Health [Safety and Tolerability] (26 weeks); Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (26 weeks). Eligibility reviewed: Age 18 Years to 75 Years; diagnosis/stage, prior therapy and key biomarker criteria compared with site summary. Full exclusions remain in the registry. Literature access limit: No usable primary abstract was independently recovered for this record in this pass. Current registry protocol was the main source; detailed sponsor or conference data remain dependent on the cited source and were not fully reverified.
predict1d-cgm-autoantibody
Outcome: No additional discrepancy identified in the reviewed summary/design/endpoint and eligibility fields. Existing sponsor or historical claims are not all independently certified by this protocol comparison.
Registry: NCT05777330. Endpoint reviewed: Progression to persistent dysglycemia (2-3 years); Progression to persistent dysglycemia and stage 3 type 1 diabetes (2-3 years). Eligibility reviewed: Age 5 Years to 39 Years; diagnosis/stage, prior therapy and key biomarker criteria compared with site summary. Full exclusions remain in the registry. Literature access limit: No usable primary abstract was independently recovered for this record in this pass. Current registry protocol was the main source; detailed sponsor or conference data remain dependent on the cited source and were not fully reverified.
prise-hatg-sab-142
Outcome: Corrected random vsstimulated screeningCpeptide and passedestimatedstart; removed absolute onceever rabbitATG claim. Corrected direct item relationships; shared class or background is insufficient.
Registry: NCT07670650. Endpoint reviewed: Area under the concentration-time curve (AUC) of C-peptide after a 2 hour mixed meal tolerance test (MMTT) (Dose administration to 12 Months). Eligibility reviewed: Age 5 Years to 40 Years; diagnosis/stage, prior therapy and key biomarker criteria compared with site summary. Full exclusions remain in the registry. Literature access limit: No usable primary abstract was independently recovered for this record in this pass. Current registry protocol was the main source; detailed sponsor or conference data remain dependent on the cited source and were not fully reverified.
protect-extension-teplizumab
Outcome: No additional discrepancy identified in the reviewed summary/design/endpoint and eligibility fields. Existing sponsor or historical claims are not all independently certified by this protocol comparison.
Registry: NCT04598893. Endpoint reviewed: Incidence of adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESIs), including infections and malignancies (During 42 months of follow-up). Eligibility reviewed: Age 9 Years to 19 Years; diagnosis/stage, prior therapy and key biomarker criteria compared with site summary. Full exclusions remain in the registry. Literature access limit: No usable primary abstract was independently recovered for this record in this pass. Current registry protocol was the main source; detailed sponsor or conference data remain dependent on the cited source and were not fully reverified.
protect-teplizumab-newonset
Outcome: PrimaryITT Cpeptide/secondarynull results verified. Added10Sep2026 prespecified per-protocol275participant publication with nominalTIR benefit and selection/adverseevent exclusions explicitly distinguished from originalITT.
Registry: NCT03875729. Endpoint reviewed: Change in C-peptide ln(AUC+1) Standardized by Duration of the Mixed Meal Tolerance Test (MMTT) (Baseline to Week 78). Eligibility reviewed: Age 8 Years to 17 Years; diagnosis/stage, prior therapy and key biomarker criteria compared with site summary. Full exclusions remain in the registry. Additional source access: Original PROTECT primary abstract; 10 September 2026 per-protocol full report. Interpretation: The selected275participant per-protocol analysis uses nominalp values; its secondary benefits do not replace the original randomized intention-to-treat secondary null results. Exclusion of lowadherence/adverseevent discontinuations matters.
protege-teplizumab-newonset
Outcome: Corrected direct item relationships; shared class or background is insufficient.
Registry: NCT00385697. Endpoint reviewed: Number of Subjects in Segment 2 With Both a Total Daily Insulin Dose of Less Than 0.5 U/kg/Day and Hemoglobin A1c (HbA1c) Level of Less Than 6.5%. (52 weeks after randomization); Number of Subjects in Segment 1 With Both a Total Daily Insulin Dose of Less Than 0.5 U/kg/Day and Hemoglobin A1c (HbA1c) Level of Less Than 6.5%. (52 weeks after first dose); Mean HbA1c Change From Baseline in Segment 2 (52 weeks after randomization); Mean HbA1c Change From Baseline in Segment 1 (52 weeks after first dose). Eligibility reviewed: Age 8 Years to 35 Years; diagnosis/stage, prior therapy and key biomarker criteria compared with site summary. Full exclusions remain in the registry. Additional source access: Teplizumab for treatment of type 1 diabetes (Protégé study): 1-year results from a randomised, placebo-controlled trial.; Teplizumab preserves C-peptide in recent-onset type 1 diabetes: two-year results from the randomized, placebo-controlled Protégé trial..
qualitative-meal-size-aid
Outcome: Replaced vague eligibility with substantive registry age, diagnosis, treatment and key biomarker restrictions; no efficacy inferred.
Registry: NCT06687434. Endpoint reviewed: Percentage of time in target range (70-18mg/dl) (Screening, after 4-6 weeks, after 3 months and after 6 months); Hemoglobin A1C (Screening, after 4-6 weeks, after 3 months and after 6 months); Percentage Continuous glucose monitoting usage (Screening, after 4-6 weeks, after 3 months and after 6 months); Number of Episodes of severe hypoglycemia (Screening, after 4-6 weeks, after 3 months and after 6 months); Number of episodes of Diabetic Ketoacidosis (Screening, after 4-6 weeks, after 3 months and after 6 months). Eligibility reviewed: Age 6 Years to 18 Years; diagnosis/stage, prior therapy and key biomarker criteria compared with site summary. Full exclusions remain in the registry. Literature access limit: No usable primary abstract was independently recovered for this record in this pass. Current registry protocol was the main source; detailed sponsor or conference data remain dependent on the cited source and were not fully reverified.
rezpegaldesleukin-newonset
Outcome: Corrected direct item relationships; shared class or background is insufficient.
Registry: NCT07142252. Endpoint reviewed: The area under the stimulated C-peptide curve (AUC) Y_MAUC. (12 Months). Eligibility reviewed: Age 8 Years to 45 Years; diagnosis/stage, prior therapy and key biomarker criteria compared with site summary. Full exclusions remain in the registry. Literature access limit: No usable primary abstract was independently recovered for this record in this pass. Current registry protocol was the main source; detailed sponsor or conference data remain dependent on the cited source and were not fully reverified.
rgb-5088-islet-cell-injection
Outcome: Corrected misreading of inclusion wording: prior organ transplant permitted, not mandatory. Removed unsupported absolute claims about all transplant recipients and all historical grafts; separate2024 case remains distinguished.
Registry: NCT06731218. Endpoint reviewed: Safety as assessed by number of subjects with adverse events (From RGB-5088 transplantation to one year later); Proportion of subjects with HbA1c ≤ 6.5% and free of severe hypoglycemic events (From 90 days to 365 days after RGB-5088 transplantation). Eligibility reviewed: Age 18 Years to 60 Years; diagnosis/stage, prior therapy and key biomarker criteria compared with site summary. Full exclusions remain in the registry. Additional source access: Transplantation of chemically induced pluripotent stem-cell-derived islets under abdominal anterior rectus sheath in a type 1 diabetes patient.; Illuminating the future of diabetes treatment: Autologous CiPSC-derived islets take center stage..
rome-gs-cgm
Outcome: No additional discrepancy identified in the reviewed summary/design/endpoint and eligibility fields. Existing sponsor or historical claims are not all independently certified by this protocol comparison.
Registry: NCT07518004. Endpoint reviewed: Mean absolute relative difference (MARD) for paired sensor and reference measurements post-insertion. (365 days post-insertion); Number of device-related or sensor insertion/removal procedure-related serious adverse events (365 days post-insertion and follow-up). Eligibility reviewed: Age 18 Years to unspecified; diagnosis/stage, prior therapy and key biomarker criteria compared with site summary. Full exclusions remain in the registry. Literature access limit: No usable primary abstract was independently recovered for this record in this pass. Current registry protocol was the main source; detailed sponsor or conference data remain dependent on the cited source and were not fully reverified.
safeguard-sab-142
Outcome: Added current PartC24month endpoint, corrected15-year-olds described asadults and qualified cross-trialcomparability/powerclaim.
Registry: NCT07187531. Endpoint reviewed: Part A: Incidence of treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), and serious adverse events (SAEs) (From dose administration through Week 4); Part B: Area under the concentration-time curve (AUC) of C-peptide after a 2 hour mixed meal tolerance test (MMTT) (From dose administration up to Month 12); Part C: Area under the concentration-time curve (AUC) of C-peptide after a 2-hour mixed meal tolerance test (MMTT). (Baseline and Month 24). Eligibility reviewed: Age 5 Years to 40 Years; diagnosis/stage, prior therapy and key biomarker criteria compared with site summary. Full exclusions remain in the registry. Literature access limit: No usable primary abstract was independently recovered for this record in this pass. Current registry protocol was the main source; detailed sponsor or conference data remain dependent on the cited source and were not fully reverified.
sana-sc451-hypoimmune
Outcome: Corrected direct item relationships; shared class or background is insufficient.
Additional source access: Hypoimmune islets achieve insulin independence after allogeneic transplantation in a fully immunocompetent non-human primate.; Survival of Transplanted Allogeneic Beta Cells with No Immunosuppression.; The future of type 1 diabetes therapy.; Cell therapy for type 1 diabetes: Tracing historical progress and exploring emerging technologies.. Specific limit: This is an unregistered pipeline record, not a registered SC451 human trial. Accessible2025 UP421 abstract concerns a distinct donor-islet product and one patient;2026 follow-up letter metadata located but no abstract/full-text recovered. Do not treat it as SC451 human efficacy.
scd0503-oral-insulin
Outcome: No additional discrepancy identified in the reviewed summary/design/endpoint and eligibility fields. Existing sponsor or historical claims are not all independently certified by this protocol comparison.
Registry: NCT07634770. Endpoint reviewed: AUCins.0-6h, area under the serum insulin concentration curve from 0 to 6 hours (From enrollment to the end of treatment in 4 months); Cins.max, maximum observed insulin concentration (From enrollment to the end of treatment in 4 months); AUCGIR.0-6h, area under the insulin concentration-time curve from 0 to 6 hours (From enrollment to the end of treatment in 4 months); GRELcl, Relative biopotency (will be derived of the dose corrected ratio of AUCGIR.0-6h for oral and sc insulin) (From enrollment to the end of treatment in 4 months). Eligibility reviewed: Age 18 Years to 64 Years; diagnosis/stage, prior therapy and key biomarker criteria compared with site summary. Full exclusions remain in the registry. Literature access limit: No usable primary abstract was independently recovered for this record in this pass. Current registry protocol was the main source; detailed sponsor or conference data remain dependent on the cited source and were not fully reverified.
semaglutide-closed-loop-meal-strategies
Outcome: Corrected2×4 to registered2×3 crossover factorial design; supplied eligibility and distinguished glycemic adjunct from regeneration. Corrected direct item relationships; shared class or background is insufficient.
Registry: NCT06387199. Endpoint reviewed: Percentage of daytime plasma glucose levels spent in target range (semaglutide vs. placebo) (24 weeks). Eligibility reviewed: Age unspecified to unspecified; diagnosis/stage, prior therapy and key biomarker criteria compared with site summary. Full exclusions remain in the registry. Literature access limit: No usable primary abstract was independently recovered for this record in this pass. Current registry protocol was the main source; detailed sponsor or conference data remain dependent on the cited source and were not fully reverified.
semaglutide-obesity-t1d-phase3
Outcome: Replaced vague eligibility with substantive registry age, diagnosis, treatment and key biomarker restrictions; no efficacy inferred. Corrected direct item relationships; shared class or background is insufficient.
Registry: NCT06909006. Endpoint reviewed: Body weight (74 weeks). Eligibility reviewed: Age 18 Years to unspecified; diagnosis/stage, prior therapy and key biomarker criteria compared with site summary. Full exclusions remain in the registry. Literature access limit: No usable primary abstract was independently recovered for this record in this pass. Current registry protocol was the main source; detailed sponsor or conference data remain dependent on the cited source and were not fully reverified.
semaglutide-teplizumab-stage2
Outcome: No additional discrepancy identified in the reviewed summary/design/endpoint and eligibility fields. Existing sponsor or historical claims are not all independently certified by this protocol comparison.
Registry: NCT06338553. Endpoint reviewed: Investigate the impact of GLP-1Ra on postprandial glycemia in a pilot study (During the MMTT in which the participant is randomly selected to receive semaglutide (Rybelsus®), glucose level will be checked at timepoints -30, -15, 0, 10, 20, 30, 60, 90, 120, 150, 180, and 240 minutes); Study the impact of GLP-1Ra on the disposition index (DI) in a pilot study (Based on the glucose and insulin readings obtained at timepoints -30, -15, 0, 10, 20, 30, 60, 90, 120, 150, 180, and 240 min and calculated approximately 1 month following completion of the MMTT once insulin levels in plasma are resulted.); Determine the impact of GLP-1Ra on endothelial function in a pilot study (During the last 30 minutes of each MMTT, between the 210 and 240 timepoints); Determine how much GLP-1Ra monotherapy therapy changes the disposition index (DI) in a pilot study of early stage 3 T1DM. (During the MMTT in which the participant is randomly selected to receive semaglutide (Rybelsus®), glucose level will be checked at timepoints -30, -15, 0, 10, 20, 30, 60, 90, 120, 150, 180, and 240 minutes). Eligibility reviewed: Age 12 Years to 50 Years; diagnosis/stage, prior therapy and key biomarker criteria compared with site summary. Full exclusions remain in the registry. Literature access limit: No usable primary abstract was independently recovered for this record in this pass. Current registry protocol was the main source; detailed sponsor or conference data remain dependent on the cited source and were not fully reverified.
sempa-semaglutide-empagliflozin-aid
Outcome: Replaced vague eligibility with substantive registry age, diagnosis, treatment and key biomarker restrictions; no efficacy inferred. Corrected direct item relationships; shared class or background is insufficient.
Registry: NCT06894784. Endpoint reviewed: Time-in-Range (At days 7, 35, 63 of the titration period and days 3 and 7 of each intervention.). Eligibility reviewed: Age 18 Years to unspecified; diagnosis/stage, prior therapy and key biomarker criteria compared with site summary. Full exclusions remain in the registry. Literature access limit: No usable primary abstract was independently recovered for this record in this pass. Current registry protocol was the main source; detailed sponsor or conference data remain dependent on the cited source and were not fully reverified.
seraxis-sr-02-phase-1-2
Outcome: No additional discrepancy identified in the reviewed summary/design/endpoint and eligibility fields. Existing sponsor or historical claims are not all independently certified by this protocol comparison.
Registry: NCT07581197. Endpoint reviewed: To investigate the safety and tolerability of SR-02 when implanted in subjects with T1D and Level 3 hypoglycemia as assessed by CIT-TCAE v5.0. (Day 35 to Day 365); Change in C-peptide secretion from baseline. (Enrollment to Day 365). Eligibility reviewed: Age 18 Years to 65 Years; diagnosis/stage, prior therapy and key biomarker criteria compared with site summary. Full exclusions remain in the registry. Literature access limit: No usable primary abstract was independently recovered for this record in this pass. Current registry protocol was the main source; detailed sponsor or conference data remain dependent on the cited source and were not fully reverified.
sernova-cell-pouch
Outcome: Added critical supplementalportal-vein islet confounding disclosed by sponsorSep12,2024; firstcohort insulinindependence is not pouch-alone efficacy. Removed unrelatedVertex/stemcelltrialrelationships. Corrected direct item relationships; shared class or background is insufficient.
Registry: NCT03513939. Endpoint reviewed: To assess the safety of the Cell Pouch following implantation, and islet transplantation, by evaluating the incidence and severity of adverse events (AEs) determined to be probable or highly probable to the Cell Pouch (365 days ±14 days). Eligibility reviewed: Age 18 Years to 65 Years; diagnosis/stage, prior therapy and key biomarker criteria compared with site summary. Full exclusions remain in the registry. Additional source access: Diabetes Is Reversed in a Murine Model by Marginal Mass Syngeneic Islet Transplantation Using a Subcutaneous Cell Pouch Device.; Sponsor primary report explicitly describing supplemental portal-vein transplants. Specific limit: Accessible primary mouse study is preclinical only. Human results are sponsor interim data; supplemental intraportal grafts prevent attributing cohortA insulin independence to the pouch alone. Latest company financial guidance was not independently re-audited here.
shield-t1d-shingrix-semaglutide
Outcome: No additional discrepancy identified in the reviewed summary/design/endpoint and eligibility fields. Existing sponsor or historical claims are not all independently certified by this protocol comparison.
Registry: NCT07614412. Endpoint reviewed: Change in 2-hour stimulated C-peptide Area Under the Curve (AUC) during a Mixed Meal Tolerance Test (MMTT) (Baseline and 12 months). Eligibility reviewed: Age 18 Years to 50 Years; diagnosis/stage, prior therapy and key biomarker criteria compared with site summary. Full exclusions remain in the registry. Literature access limit: No usable primary abstract was independently recovered for this record in this pass. Current registry protocol was the main source; detailed sponsor or conference data remain dependent on the cited source and were not fully reverified.
sibionics-gs3-accuracy
Outcome: No additional discrepancy identified in the reviewed summary/design/endpoint and eligibility fields. Existing sponsor or historical claims are not all independently certified by this protocol comparison.
Registry: NCT07745244. Endpoint reviewed: System performance (15 days); System-related Safety (15 days). Eligibility reviewed: Age 18 Years to unspecified; diagnosis/stage, prior therapy and key biomarker criteria compared with site summary. Full exclusions remain in the registry. Literature access limit: No usable primary abstract was independently recovered for this record in this pass. Current registry protocol was the main source; detailed sponsor or conference data remain dependent on the cited source and were not fully reverified.
simplified-meal-bolus-hcl-adolescents
Outcome: Replaced vague eligibility with substantive registry age, diagnosis, treatment and key biomarker restrictions; no efficacy inferred.
Registry: NCT06575790. Endpoint reviewed: Time in Range (Measured during the duration of the study period, up to 12 weeks). Eligibility reviewed: Age 14 Years to 26 Years; diagnosis/stage, prior therapy and key biomarker criteria compared with site summary. Full exclusions remain in the registry. Literature access limit: No usable primary abstract was independently recovered for this record in this pass. Current registry protocol was the main source; detailed sponsor or conference data remain dependent on the cited source and were not fully reverified.
sophist-sotagliflozin-hf
Outcome: No additional discrepancy identified in the reviewed summary/design/endpoint and eligibility fields. Existing sponsor or historical claims are not all independently certified by this protocol comparison.
Registry: NCT06435156. Endpoint reviewed: Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score (From baseline to week 16). Eligibility reviewed: Age 18 Years to 84 Years; diagnosis/stage, prior therapy and key biomarker criteria compared with site summary. Full exclusions remain in the registry. Literature access limit: No usable primary abstract was independently recovered for this record in this pass. Current registry protocol was the main source; detailed sponsor or conference data remain dependent on the cited source and were not fully reverified.
sorafenib-newonset-t1d
Outcome: Replaced vague eligibility with substantive registry age, diagnosis, treatment and key biomarker restrictions; no efficacy inferred.
Registry: NCT06227221. Endpoint reviewed: The primary endpoint of the study is the change from baseline of serum C-peptide area under the curve (AUC) over 2 hours following a mixed meal (Measured at week 26). Eligibility reviewed: Age 18 Years to 60 Years; diagnosis/stage, prior therapy and key biomarker criteria compared with site summary. Full exclusions remain in the registry. Literature access limit: No usable primary abstract was independently recovered for this record in this pass. Current registry protocol was the main source; detailed sponsor or conference data remain dependent on the cited source and were not fully reverified.
sotagliflozin-volagidemab-adjunct
Outcome: Corrected estimated24 enrollment falsely described asactualcompleted enrollment; specified keyeligibility. Corrected direct item relationships; shared class or background is insufficient.
Registry: NCT05696366. Endpoint reviewed: Change in HbA1c (12 weeks). Eligibility reviewed: Age 18 Years to 70 Years; diagnosis/stage, prior therapy and key biomarker criteria compared with site summary. Full exclusions remain in the registry. Literature access limit: No usable primary abstract was independently recovered for this record in this pass. Current registry protocol was the main source; detailed sponsor or conference data remain dependent on the cited source and were not fully reverified.
stage-2-tzield-registry
Outcome: No additional discrepancy identified in the reviewed summary/design/endpoint and eligibility fields. Existing sponsor or historical claims are not all independently certified by this protocol comparison.
Registry: NCT06481904. Endpoint reviewed: Number of adverse events of special interests (AESI) (Throughout the study, approximately 10 years); Number of serious adverse events (SAE) (Throughout the study, approximately 10 years); Number of adverse events (AE) in mothers, fetuses, and infants exposed to TZIELD during pregnancy (From start of pregnancy to 12 months post-partum); Number of maternal pregnancy-related events (From start of pregnancy to 12 months post-partum); Developmental outcomes of the infant (From birth of infant to 12 months). Eligibility reviewed: Age unspecified to unspecified; diagnosis/stage, prior therapy and key biomarker criteria compared with site summary. Full exclusions remain in the registry. Literature access limit: No usable primary abstract was independently recovered for this record in this pass. Current registry protocol was the main source; detailed sponsor or conference data remain dependent on the cited source and were not fully reverified.
stren-italy-autoantibody-followup
Outcome: No additional discrepancy identified in the reviewed summary/design/endpoint and eligibility fields. Existing sponsor or historical claims are not all independently certified by this protocol comparison.
Registry: NCT07503366. Endpoint reviewed: Progression to Stage 3 Type 1 Diabetes (Up to 10 years from baseline for each participant.). Eligibility reviewed: Age unspecified to unspecified; diagnosis/stage, prior therapy and key biomarker criteria compared with site summary. Full exclusions remain in the registry. Literature access limit: No usable primary abstract was independently recovered for this record in this pass. Current registry protocol was the main source; detailed sponsor or conference data remain dependent on the cited source and were not fully reverified.
stride-siplizumab
Outcome: No additional discrepancy identified in the reviewed summary/design/endpoint and eligibility fields. Existing sponsor or historical claims are not all independently certified by this protocol comparison.
Registry: NCT06025110. Endpoint reviewed: Change from baseline in beta-cell function as compared to placebo at week 52. (52 weeks). Eligibility reviewed: Age 18 Years to 45 Years; diagnosis/stage, prior therapy and key biomarker criteria compared with site summary. Full exclusions remain in the registry. Literature access limit: No usable primary abstract was independently recovered for this record in this pass. Current registry protocol was the main source; detailed sponsor or conference data remain dependent on the cited source and were not fully reverified.
sugar-n-salt-sotagliflozin
Outcome: No additional discrepancy identified in the reviewed summary/design/endpoint and eligibility fields. Existing sponsor or historical claims are not all independently certified by this protocol comparison.
Registry: NCT06217302. Endpoint reviewed: eGFR at the end of the wash-out period following the treatment period (End of the 2-month wash-out period following the 3-year treatment period (weeks 162 and 164)). Eligibility reviewed: Age 18 Years to 75 Years; diagnosis/stage, prior therapy and key biomarker criteria compared with site summary. Full exclusions remain in the registry. Literature access limit: No usable primary abstract was independently recovered for this record in this pass. Current registry protocol was the main source; detailed sponsor or conference data remain dependent on the cited source and were not fully reverified.