About — what changed

Freshness & changelog.

Provenance you can see. Material changes from each monthly refresh are grouped at the top. Below that is every record, most-recently-reviewed first, so you always know how current a ranking’s evidence is.

411 records · 0 still seed

New means a record was first added on that date. Updated means an existing record was reviewed on that date.

September 2026

First September 2026 evidence pass. Australia’s PBAC did not recommend teplizumab for PBS listing. DIAGNODE-3 is now terminated on ClinicalTrials.gov for futility. New records include OPT101, ASITI-201, TIRTLE2, two teplizumab real-world studies, INNODIA DETECT and ACCESS-T1D screening, PredicT1D, Precision T1D Platform, Novo’s T1D zalfermin study, Leiden tolDC, Japanese TUFF-IPC, NOMAD, and a pediatric InPen study. Type 2 programmes were not added.

Cutoff 27 Aug 2026 · 49 material changes

• ItemTeplizumab (Tzield)27 Aug 2026Australia’s PBAC did not recommend PBS listing of Tzield in July 2026. TGA registration stands; subsidy does not. Access score 62 → 58.
• ItemOPT101 (CD40-pathway peptide)27 Aug 2026New. CD154-derived peptide OPT101; Phase 1b results posted 10 August 2026 show a small safety dataset and no C-peptide advantage over placebo.
• TrialOPT101 Phase 1b in adults with type 1 diabetes27 Aug 2026New. NCT05428943 completed; 24 started, 18 completed; posted mixed-meal C-peptide means were not higher on drug than placebo.
• TrialAL1GN: long-term outcomes of teplizumab in routine care27 Aug 2026New. Sanofi AL1GN observational cohort (NCT07360080) is recruiting ~1,000 people treated with teplizumab in routine stage-2 care, followed up to 10 years.
• TrialNOMAD: unannounced meals on open-source vs commercial AID27 Aug 2026New. NOMAD (NCT07758647) will compare open-source vs Control-IQ/Omnipod 5 during unannounced meals; not yet recruiting, estimated start October 2026.
• TrialEvaluating the InPen in pediatric type 1 diabetes27 Aug 2026New. NCT05515939 InPen in pediatric T1D is active, not recruiting (n≈34); no results posted; primary completion estimated November 2026.
• TrialTegoprubart: calcineurin-inhibitor-free islet-transplant immunosuppression27 Aug 2026Registry moved from recruiting to active, not recruiting. The June 2026 12/12 insulin-independence update remains sponsor/conference data, not a posted result, and is still not immunosuppression-free.
• TrialTrialNet platform: teplizumab vs low-dose ATG to delay stage-3 T1D27 Aug 2026Corrected to not-yet-recruiting to match ClinicalTrials.gov. TrialNet’s ASCEND page still says enrolling; both facts are shown.
• TrialMiniMed Fit payload wear study in children and adolescents27 Aug 2026Completed 7 August 2026 with actual n=59 (was recruiting, estimated 100). No results posted. Adhesive payload study, not insulin-delivery efficacy.
• TrialVX-264: encapsulated stem-cell islets without immunosuppression27 Aug 2026ClinicalTrials.gov still lists active, not recruiting (n=7 follow-up). Vertex discontinued the program in 2025; this record stays terminated.
• TrialLow-dose glucagon before exercise while using AID27 Aug 2026Now recruiting (NCT07427251), previously not-yet-recruiting. No results.
• TrialDIAGNODE-2: Intralymphatic GAD-alum (Diamyd) in recent-onset type 1 diabetes27 Aug 2026Summary/results no longer say DIAGNODE-3 is “now being tested” or still enrolling DR3-DQ2 patients. That Phase 3 was terminated for futility.
• TrialDIAGNODE-3: Intralymphatic GAD-alum in HLA DR3-DQ2 recent-onset T1D27 Aug 2026ClinicalTrials.gov now lists DIAGNODE-3 TERMINATED, whyStopped “Stopped for futility.”, actual n=321, completed 24 June 2026. No results posted.
• TrialTADPOL: DFMO/polyamine pathway in recent-onset T1D27 Aug 2026Live registry: actual enrolment 74 (was estimated 81) and primary completion June 2027 (was December 2027). Still no results.
• TrialTIRTLE2: acute metabolic effects of tirzepatide in T1D27 Aug 2026New. TIRTLE2 (NCT06820281) recruiting Phase 2 clamp study of 6-week tirzepatide 2.5 mg in T1D; estimated n=44. Not a T1D approval.
• TrialTeplizumab managed-access programmes: retrospective real-world cohort27 Aug 2026New. NCT07457580 recruiting retrospective teplizumab managed-access chart review (n≈60). Distinct from prospective AL1GN.
• TrialINNODIA DETECT: family and friends autoantibody screening27 Aug 2026New. INNODIA DETECT (NCT07118098) recruiting European relatives/friends autoantibody screen; estimated n=30,000.
• ItemASITI-201 (proinsulin peptide / calcitriol liposomes)27 Aug 2026New. Queensland Phase 1 antigen-specific liposome (proinsulin peptide plus calcitriol). Registry recruiting; Part A complete, Part B open; no efficacy results.
• TrialASITI-201 Phase 1 in stage 3 T1D (Queensland)27 Aug 2026New. ACTRN12624001043527 recruiting; target n=36, accrual 27 as of 2 July 2026. Safety primary; mixed-meal C-peptide is a Part B secondary, not a posted result.
• TrialPrecision T1D Platform: finerenone or sotagliflozin for cardio-renal risk27 Aug 2026New. NCT07594145 not-yet-recruiting T1D Phase 2 of finerenone or sotagliflozin for early kidney/heart-risk markers (n≈57). Type 2 excluded.
• TrialNNC0194-0499 (zalfermin) ± semaglutide in adults with T1D27 Aug 2026New. NCT07087795 active, not recruiting Phase 1 of zalfermin ± semaglutide in T1D (n≈96). No results. NASH discontinuation is not a T1D result.
• TrialPredicT1D: CGM to predict dysglycemia in autoantibody-positive people27 Aug 2026New. NCT05777330 recruiting Belgian CGM/OGTT staging study in autoantibody-positive people aged 5–39 (n≈75). No results.
• TrialACCESS-T1D: Florida relatives and autoimmune-risk screening27 Aug 2026New. NCT06908057 ACCESS-T1D Florida relatives/autoimmune screen; active, not recruiting; actual n=115. No results posted.
• ItemTUFF-IPC autologous adipose-derived insulin-producing cells27 Aug 2026New. Japanese first-in-human TUFF-IPC (autologous adipose-derived insulin-producing cells); jRCT2063250055 recruiting, target n=3. No results.
• TrialTUFF-IPC Phase 1/2a: autologous adipose-derived insulin-producing cells27 Aug 2026New. jRCT2063250055 recruiting Phase 1/2a in Tokushima; safety to day 60 is primary. Fasting C-peptide ≥0.3 ng/mL (0.1 nmol/L) is protocol engraftment, not a posted result.
• ItemLeiden tolerogenic dendritic-cell therapy27 Aug 2026New. LUMC autologous tolerogenic dendritic-cell programme; distinct from City of Hope PIpepTolDC. Phase 1b recruiting; first-patient news is n=1.
• TrialLUMC Phase 1b: tolerogenic dendritic cells in recent-onset T1D27 Aug 2026New. EUCT 2023-508558-25-01 recruiting in the Netherlands; target n=10. No posted C-peptide results.
• TrialTeplizumab in Japanese stage-2 T1D27 Aug 2026Live registry ages are 1–34 (was written 8–34). Still recruiting, n=10 estimated; no results.
• ItemDexcom G727 Aug 2026Added FDA Class II recall number Z-2574-2026 for the two stolen/resold G7 lots already described. Not a G7 design defect.
• ItemAbbott Libre Duo27 Aug 2026FDA De Novo authorization 25 August 2026 for the 10-day dual glucose-ketone sensor, ages 2+. Authorization is not a US or EU launch.
• ItemInsulin efsitora alfa (basal Fc)27 Aug 2026NICE discontinued its type 1 appraisal on 30 July 2026 after Lilly said it was not pursuing a UK type 1 licence. CHMP’s type-2-only Onswik opinion is still not a marketing authorisation.
• TrialEvaluating the InPen in pediatric type 1 diabetes27 Aug 2026Live registry is ages 13–21 at Wayne State (was written 2–17). Still active, not recruiting; no results.
• TrialELSA: EarLy Surveillance for Autoimmune diabetes (UK)27 Aug 2026ISRCTN target enrolment is now 50,000 (was 20,000); estimated completion 31 August 2029. Still recruiting. 17,283 remains an interim count.
• ItemIMC-S118AI (PPI × PD-1 ImmTAAI)27 Aug 2026New. Immunocore IMC-S118AI (pre-proinsulin × PD-1). First-in-human registered; no human efficacy.
• TrialIMC-S118AI first-in-human dose-escalation in T1D27 Aug 2026New. NCT07493122 not yet recruiting on ClinicalTrials.gov; EU CTIS authorised July 2026. No results.
• TrialOPT101 Phase 2 subcutaneous PK and pilot efficacy in T1D27 Aug 2026New. NCT06964087 recruiting subcutaneous OPT101 Phase 2 (n≈72). Not a posted C-peptide result.
• TrialCNK-UT009 universal CAR-T / NKT injection in T1D27 Aug 2026New. NCT07051564 / ChiCTR2600116392 recruiting Chinese universal CAR-T/NKT in T1D. Safety first; no results.
• TrialSOPHIST: sotagliflozin for heart-failure symptoms in T1D27 Aug 2026New. NCT06435156 recruiting UK Phase 2 of sotagliflozin in T1D with heart failure (n≈320). Type 2 HF data do not score this record.
• TrialSUGARNSALT: sotagliflozin to slow kidney decline in T1D CKD27 Aug 2026New. NCT06217302 recruiting T1D CKD Phase 3 of sotagliflozin (n≈150). Not a Type 1 licence.
• ItemD1Ce Screen / Italy national screening (Law 130/2023)27 Aug 2026Italy’s first national wave is 5- and 6-year-olds at vaccination visits, not every child aged 1–17. Reach 92 → 70; access 80 → 72.
• ItemPIpepTolDC tolerogenic dendritic-cell vaccine27 Aug 2026Phase 1 enrollment is complete (actual n=6). Follow-up continues; no results posted.
• ItemCadisegliatin (oral glucokinase activator)27 Aug 2026CATT1 is ACTIVE_NOT_RECRUITING on the live registry. Primary completion estimated April 2027 — not the older H2 2026 topline.
• ItemConcept: closed loops that act on ketones27 Aug 2026Libre Duo 10 Day is FDA-authorized (25 Aug 2026), so the ketone sensor exists. No AID algorithm yet acts on the ketone channel. Authorization ≠ launch.
• ItemMiniMed Flex pump27 Aug 2026MiniMed began commercially shipping Flex with Abbott Instinct in the US on 17 August 2026. Shipping is not Flex-specific outcome data.
• ItemInstinct sensor (made by Abbott, sold by MiniMed)27 Aug 2026Instinct now ships with MiniMed Flex in the US (17 August 2026), in addition to 780G and MiniMed Go.
• ItemMiniMed Flex (formerly NMX8-AID)27 Aug 2026Flex + Instinct US shipping began 17 August 2026; Instinct is no longer a summer promise on this AID record.
• ItemGolimumab (anti-TNF)27 Aug 2026TrialNet stage-1 golimumab substudy (NCT07683026) is still not-yet-recruiting after its estimated 8 August 2026 start.
• TrialAdaptive platform trial: golimumab in stage 1 (presymptomatic) T1D27 Aug 2026Estimated start 8 August 2026 has passed; live registry remains not-yet-recruiting (last update 6 July 2026).
• TrialPIpepTolDC tolerogenic dendritic-cell vaccine27 Aug 2026Enrollment complete, actual n=6. Follow-up estimated through 15 December 2026. No results posted.

← August 2026