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. Review dates show editorial activity; they do not certify that every claim has been verified.
484 records · 0 still seed
New means a record was first added on that date. Updated means an existing record was reviewed on that date.
How we review and score the evidence →
October 2026
October 2026 monthly refresh and data-hardening sweep (cutoff 2026-10-19): added the 16 September 2026 FDA approval of Kerendia (finerenone) for T1D-associated chronic kidney disease; recorded once-weekly insulin efsitora alfa (Onswik) approvals in the US, EU, and UK for type 2 diabetes only alongside the explicit FDA warning against type 1 diabetes use; updated Australia's 1 October 2026 NDSS subsidy expansion for FreeStyle Libre 3 Plus and deletion of Dexcom G6; documented FDA 510(k) clearances for CamAPS FX iOS, Beta Bionics Mint ACE pump, twiist adult type 2 expansion, Modular Medical Pivot, and Garzulys interchangeable insulin aspart biosimilar; added safety and recall notices for FreeStyle Libre 3/3 Plus, MiniMed Flex, Tandem t:slim X2 iOS beta, and UK Levemir discontinuation; added 8 newly registered clinical trials; and refreshed all 242 existing trial records against ClinicalTrials.gov, EU CTIS, ANZCTR, and WHO ICTRP.
Baseline review cutoff 27 Aug 2026 · 65 material changes
26 Oct 2026 · Cure pillar deep-dive expansion and evidence-not-intent ranking calibration
Refresh by Gemini 4 Argon (high effort)
Contributors: Gemini 4 Argon (high effort): PubMed E-utilities and ClinicalTrials.gov API v2 primary-source verification for 9 newly added cure pipeline therapies and 6 clinical trials · Gemini 4 Argon (high effort): Full-pillar scoring calibration across all 61 curing records to enforce evidence-not-intent scoring for preclinical candidates and demote discontinued trials
Added 9 missing T1D cure pipeline therapies (Sana UP421, Eledon tegoprubart AT-1501, NextCell ProTrans, Avotres AVT001, Imcyse IMCY-0098, Defymed MailPan/ExOlin, Weill Cornell GINS organoids, Parvus Navacim PVT101/PVT201, and Quell/AstraZeneca QEL-002 CAR-Treg) and 6 clinical trial records, and recalibrated 41 existing cure records so preclinical candidates with zero human data are scored strictly on demonstrated evidence rather than design intent.
- AI-assisted editorial refresh and primary-source verification; independent clinician certification remains pending.
19 Oct 2026 · October 2026 monthly refresh and primary-source verification sweep
Refresh by Gemini 4 Argon (high effort)
Contributors: Gemini 4 Argon (high effort): ClinicalTrials.gov API v2, EU CTIS, ANZCTR, and WHO ICTRP/ISRCTN sweep across all 242 existing trials and 8 newly registered T1D trials · Gemini 4 Argon (high effort): FDA, EMA, MHRA, TGA/NDSS, Health Canada, and PMDA approvals, clearances, recalls, and device fact profiles · Gemini 4 Argon (high effort): PubMed, Europe PMC, EASD 2026, and GitHub open-source AID release sweep across all 15 categories
Completed the October 2026 monthly refresh and data-hardening sweep (search window 2026-09-09 to 2026-10-19) across all 15 categories and 11 source families. Updated 36 item records, added 8 newly registered clinical trial records, refreshed all 242 existing trial records to registryChecked 2026-10-19 (including 31 trials with registry status, date, enrollment, or publication updates), and updated device-facts.json, access.json, and reader-updates.json. Verified every newly added PMID/PMCID via NCBI E-utilities, every newly added/updated NCT ID via ClinicalTrials.gov API v2, and all newly added source URLs.
- AI-assisted editorial refresh and primary-source verification; independent clinician certification remains pending.
- The August corpus baseline cutoff remains 2026-08-27 so unchanged historical record review dates are not artificially bumped; all records modified in this pass carry lastReviewed: 2026-10-19, and all 250 clinical trial records carry registryChecked: 2026-10-19.
- Country-access and subsidy entries reflect documented regulatory approvals, NDSS schedules, and public health-system notices as of 19 October 2026; local clinic stock and individual eligibility rules vary.
- Item26 Oct 2026Split Sana Biotechnology's first-in-human UP421 hypoimmune primary donor-islet study (NCT06239636, Uppsala University; NEJM 2025 PMID 40757665 and 14-month NEJM follow-up 2026 PMID 42430558) into a dedicated early-evidence record separate from preclinical SC451.
- Item26 Oct 2026Added Eledon Pharmaceuticals' tegoprubart (AT-1501) calcineurin-free donor islet transplant regimen (University of Chicago Phase 1/2 trial NCT06305286, reporting 12 of 12 initial recipients achieving insulin independence with mean HbA1c ~5.4% at ADA 2026).
- Item26 Oct 2026Added NextCell Pharma's ProTrans pooled Wharton's jelly mesenchymal stromal cell therapy, covering the completed randomized Phase 2 adult trial (NCT03406585, Diabetologia 2023 PMID 37221247), repeat-dose follow-up (NCT03973827), and the 66-patient pediatric Phase 1/2 ProTrans-Young trial (NCT05061030).
- Item26 Oct 2026Added Avotres's AVT001 spHsp60-pulsed autologous dendritic cell therapy targeting HLA-E-restricted CD8+ regulatory T cells, covering the completed 25-patient randomized double-blind Phase 1/2 trial at Joslin Diabetes Center (NCT03895996, NEJM Evidence 2024 PMID 38916421).
- Item26 Oct 2026Added Imcyse's IMCY-0098 (proinsulin Imotope peptide), documenting the completed Phase 1b study (NCT03272269, BMC Medicine 2023 PMID 37226224) and the termination of the 110-patient Phase 2 IMPACT trial (NCT04524949) for lack of 1-year efficacy.
- Item26 Oct 2026Added Defymed's MailPan pre-vascularized refillable macroencapsulation bioartificial pancreas (PMID 32523669, PMID 39950714) and companion ExOlin extraperitoneal physiological insulin-diffusion device (NCT05221359).
- Item26 Oct 2026Added Weill Cornell's autologous gastric stem-cell insulin-secreting organoids (GINS, Nature Cell Biology 2023 PMID 37106062; Stem Cell Reports 2025 PMID 41202817; 2026 hypoimmune preprint PMID 42523425).
- Item26 Oct 2026Added Parvus Therapeutics' Navacim peptide-MHC class II nanomedicine platform (Santamaria Nature 2016 PMID 26886799), distinguishing preclinical T1D candidate PVT101 from clinical-stage liver (PVT201, NCT06798454) and celiac (PVT401, NCT07423000) trials.
- Item26 Oct 2026Added Quell Therapeutics and AstraZeneca's QEL-002 Foxp3-locked islet-targeted CAR-Treg programme (optioned Nov 2024), distinguishing preclinical QEL-002 in T1D from QEL-005 (NCT07473154 CHILL) in rheumatologic autoimmune diseases.
- Trial26 Oct 2026Added the completed ProTrans-1 / ProTrans-2 Phase 1/2 trial (NCT03406585, n=24) of pooled Wharton's jelly MSCs in recent-onset adult type 1 diabetes.
- Trial26 Oct 2026Added the active 66-patient pediatric and adolescent Phase 1/2 ProTrans-Young trial (NCT05061030) at Uppsala University.
- Trial26 Oct 2026Added the completed 25-patient randomized double-blind Phase 1/2 trial of AVT001 (NCT03895996) at Joslin Diabetes Center with posted registry outcomes.
- Trial26 Oct 2026Added the 110-patient multicenter Phase 2 IMPACT trial of IMCY-0098 (NCT04524949), terminated in 2024 after showing no C-peptide efficacy at 1 year.
- Trial26 Oct 2026Added the Pilot'Ex first-in-human study (NCT05221359) of Defymed's ExOlin implantable extraperitoneal insulin diffusion device at University Hospital Strasbourg.
- Trial26 Oct 2026Added Mount Sinai's completed first-in-human Phase 1 single-ascending-dose study of oral harmine hydrochloride in 25 healthy volunteers (NCT05526430, PMID 39252512).
- Item19 Oct 2026Moved finerenone (Kerendia) to available in the US following the 16 September 2026 FDA supplemental approval (NDA 215341/S-011, announced 17 September 2026) to reduce urinary albumin-to-creatinine ratio in adults with chronic kidney disease associated with type 1 diabetes, supported by the Phase 3 FINE-ONE trial (NEJM 2026; 25% greater UACR reduction vs placebo; hyperkalemia 10.1% vs 3.3%).
- Item19 Oct 2026Recorded US FDA (BLA 761408, 23 September 2026), European Commission (EU/1/26/2049, 30 September 2026), and UK MHRA (13 October 2026) approvals of once-weekly insulin efsitora alfa (Onswik) exclusively for adults with type 2 diabetes, and added the explicit US FDA label warning recommending against use in type 1 diabetes due to increased severe hypoglycemia in QWINT-5.
- Item19 Oct 2026Updated Australian access following the 1 October 2026 NDSS subsidy commencement (NDSS code 996) for all eligible people with type 1 diabetes using standalone sensing, mylife Loop, or Omnipod 5, and recorded the October 2026 Abbott FreeStyle Libre 3/3 Plus app security correction (ADC FA 1002-2026).
- Item19 Oct 2026Added the October 2026 Abbott urgent medical device correction (ADC FA 1002-2026) requiring users to update the FreeStyle Libre 3 mobile app to 3.6.4+ (iOS) or 3.6.3+ (Android) so third-party device tampering cannot mute alarms or prevent glucose updates.
- Item19 Oct 2026Updated Australian access for the 1 October 2026 deletion of Dexcom G6 sensors and transmitters (NDSS codes 955 and 960) from the Australian National Diabetes Services Scheme following the transition to Dexcom G7.
- Item19 Oct 2026Updated Australian NDSS status to reflect that Dexcom G7 replaced Dexcom G6 as the subsidised Dexcom sensor on the NDSS from 1 October 2026.
- Item19 Oct 2026Added the 16 September 2026 FDA 510(k) clearance (K261896) expanding CamAPS FX in the United States from Android-only (K232603) to compatible iOS devices while keeping the ages 2+ type 1 diabetes (including pregnancy) indication.
- Item19 Oct 2026Added the 16 September 2026 FDA 510(k) clearance (K261896) for CamAPS FX on iOS and the 1 October 2026 Australian NDSS FreeStyle Libre 3 Plus subsidy commencement for mylife Loop users.
- Item19 Oct 2026Recorded the 16 September 2026 FDA 510(k) clearance (K261896) for CamAPS FX on iOS and the 1 October 2026 Australian NDSS product schedule naming standardization for mylife YpsoPump Orbit Soft and Orbit Micro infusion sets.
- Item19 Oct 2026Added the 1 October 2026 Australian NDSS subsidy commencement for FreeStyle Libre 3 Plus (NDSS code 996), completing dual subsidised sensor choice (Dexcom G6/G7 and FreeStyle Libre 3 Plus) for Omnipod 5 AID users in Australia.
- Item19 Oct 2026Updated Australian sensor compatibility and subsidy notes for the 1 October 2026 NDSS listing of FreeStyle Libre 3 Plus alongside Omnipod 5.
- Item19 Oct 2026Updated the Beta Bionics Mint patch pump record with the 11 September 2026 FDA 510(k) clearances for the Mint ACE Pump (K260001) and iLet Dosing Decision Software (K262763) for people aged 6+ with type 1 diabetes, including two-piece reusable controller + 200 U disposable cartridge specifications (20 U minimum fill, up to 3 days + 12-hour grace wear, 2 meters for 60 minutes IPX8 water resistance) and 29 September 2026 investor day launch targets.
- Item19 Oct 2026Added the Beta Bionics Mint (iLet patch AID) automated insulin delivery system record following the 11 September 2026 FDA 510(k) clearances of the Mint ACE patch pump (K260001) and iOS/Android iLet Dosing Decision Software (K262763) with independent meal-type reset (Breakfast, Lunch, Dinner), targeting a Q1 2027 US pharmacy launch.
- Item19 Oct 2026Added the 11 September 2026 FDA 510(k) clearance of the iLet Dosing Decision Software (K262763) as an interoperable automated glycemic controller across both the tubed iLet ACE Pump and the Mint ACE patch pump.
- Item19 Oct 2026Cross-referenced the 11 September 2026 FDA 510(k) clearances for the Mint ACE patch pump (K260001) and standalone iLet Dosing Decision Software (K262763).
- Item19 Oct 2026Added the 16 October 2026 FDA 510(k) label expansion clearing the twiist automated insulin delivery system (powered by Tidepool) for adults aged 18+ with insulin-requiring type 2 diabetes alongside its existing ages 6+ type 1 diabetes indication.
- Item19 Oct 2026Recorded the 16 October 2026 FDA 510(k) clearance expanding the twiist AID system indication to adults aged 18+ with type 2 diabetes.
- Item19 Oct 2026Added the 2 September 2026 FDA Special 510(k) clearance (K262153) for the updated Pivot tubed insulin pump.
- Item19 Oct 2026Added the 15 September 2026 FDA approval of Garzulys (insulin aspart-fsan, BLA 761497/Orig 2, vertical-text autoinjector carton configuration) as a second interchangeable biosimilar to NovoLog alongside Kirsty.
- Item19 Oct 2026Added the 1 October 2026 UK DHSC/NHS National Patient Safety Alert (NatPSA/2026/006/DHSC) requiring providers to transition all remaining patients off Levemir (insulin detemir) Pensfill and FlexPen before stock exhaustion by 30 November 2026 ahead of global discontinuation on 31 December 2026.
- Item19 Oct 2026Linked Eli Lilly's newly registered Phase 1 clamp study of insulin analog LY4057996 in adults with type 1 diabetes (NCT06945406, first posted 25 September 2026) and updated NNC0363-1065 completed trial history.
- Item19 Oct 2026Recorded the 5 October 2026 FDA Class II recall (Z-0088-2027) covering 20 early-release MiniMed Flex (MMT-1940) pumps where inadvertent touch activation could prevent occlusion alarms, MiniMed's 15 October 2026 corporate separation from Medtronic (NASDAQ: MMED), and the newly registered DS5k (Unity) extended-wear sensor feeder trial (NCT07864168).
- Item19 Oct 2026Added MiniMed's 15 October 2026 corporate separation (NASDAQ: MMED), the 5 October 2026 Class II recall of 20 early-release MiniMed Flex (MMT-1940) pumps (Z-0088-2027), and the DS5k (Unity) up-to-16-day sensor trial (NCT07864168).
- Item19 Oct 2026Added Roche's EASD 2026 late-breaking clinical symposium data in Milan (30 September 2026) reporting real-world glucose forecasting and nocturnal hypoglycemia risk reduction with the Accu-Chek SmartGuide sensor and Predict app.
- Item19 Oct 2026Added the 29 September 2026 FDA Class II recall (Z-3330-2026) affecting 61 pre-release TestFlight beta instances of the t:slim Mobile App v2.13 on iOS where rapid bolus reentry could cause duplicate bolus requests; production App Store releases were unaffected.
- Item19 Oct 2026Updated the Loop open-source release record to Loop v3.12.0 (released 12 October 2026 via LoopKit/LoopWorkspace).
- Item19 Oct 2026Updated the Trio open-source release record to Trio v0.7.0 (released 13 October 2026 via nightscout/Trio).
- Item19 Oct 2026Updated the AndroidAPS open-source release record to AndroidAPS v3.4.3 (released 4 October 2026 via nightscout/AndroidAPS).
- Item19 Oct 2026Updated the iAPS open-source release record to iAPS v8.3.8 (released 3 October 2026 via Artificial-Pancreas/iAPS, raising the minimum iOS version to iOS 17.6).
- Item19 Oct 2026Verified and bound the O'Rourke et al. 2023 JCEM primary citation (PMID 36227635, PMC10210620) for Bavarian Fr1da general-population islet autoantibody screening cost-per-child and diagnostic ketoacidosis reduction metrics.
- Item19 Oct 2026Added the September 2026 STREN Italian longitudinal autoantibody follow-up cohort publication (BMJ Open 2026;16(9):e124606; PMID 42767751, PMC13599873) tracking progression from screen-detected stage 1/2 to stage 3 type 1 diabetes under Law 130/2023.
- Item19 Oct 2026Added the September 2026 T1DRA UK general-population adult islet autoantibody screening protocol and baseline cohort paper (BMJ Open 2026;16(9):e116354; PMID 42810803, PMC13630054).
- Item19 Oct 2026Updated EDENT1FI European general-population pediatric screening enrollment to 140,568 children screened across 8 countries (0.45% early-stage T1D detection rate) reported at EASD 2026 in Milan.
- Item19 Oct 2026Added the October 2026 Diabetes Care German pediatric compassionate-use analysis in children under age 8 with stage 2 type 1 diabetes (n=23, PMID 42520060, PMC13594791) and updated KIBOU-T1D Japanese Phase 3 status (NCT06791291).
- Item19 Oct 2026Added Kriya Therapeutics' two newly registered Phase 1 clinical trials — PROGRESS (NCT07829302, dual AAV VV-14299 + VV-14300) and RELIEVE (NCT07831798, VV-14300) — advancing the AAV insulin + glucokinase gene therapy programme toward first-in-human evaluation.
- Item19 Oct 2026Updated the Celregen CRG-002 chemical iPSC islet clinical status with the newly registered Phase 1/2 study NCT07645092 alongside NCT06996509.
- Item19 Oct 2026Added Century Therapeutics' 29 September 2026 EASD Milan nonclinical presentation demonstrating functional glycemic control and immune evasion of CNTY-813 iPSC-derived islet cells, with Phase 1 clinical initiation targeted for late 2026.
- Trial19 Oct 2026Added the newly registered PROGRESS Phase 1 first-in-human trial (NCT07829302) of Kriya's dual AAV gene therapy (VV-14299 + VV-14300) for brittle type 1 diabetes.
- Trial19 Oct 2026Added the newly registered RELIEVE Phase 1 open-label dose-escalation trial (NCT07831798) of Kriya's VV-14300 gene therapy in adults with type 1 diabetes.
- Trial19 Oct 2026Added the newly registered INSPIRE-T1D Phase 2 randomized double-blind placebo-controlled trial (NCT07845955) evaluating selective JAK1 inhibitor ivarmacitinib (SHR0302, 4 mg or 8 mg daily for 52 weeks) in newly diagnosed stage 3 type 1 diabetes.
- Trial19 Oct 2026Added the newly registered TrialNet VIP-1 Phase 2 randomized placebo-controlled trial (NCT07880769) evaluating oral verapamil ER (up to 360 mg daily for 104 weeks) in participants aged 12–45 with stage 1 type 1 diabetes.
- Trial19 Oct 2026Added Eli Lilly's newly registered Phase 1 euglycemic clamp study (NCT06945406) evaluating novel insulin analog LY4057996 vs insulin lispro in adults with type 1 diabetes and healthy participants.
- Trial19 Oct 2026Added MiniMed's newly registered US multicenter pivotal feeder evaluation (NCT07864168) of the DS5k (Unity) continuous glucose monitoring sensor worn for up to 16 days in participants aged 2+ with diabetes.
- Trial19 Oct 2026Added the newly authorised Phase 1 open-label crossover clamp study (EU CTIS 2025-521863-11-00) evaluating SubLin liposomal sublingual insulin tablets vs subcutaneous insulin lispro in adults with type 1 diabetes.
- Trial19 Oct 2026Added the Phase 2 randomized trial (NCT06072326, ASPIRE-1) of selective endothelin-A antagonist SC0062 alone and with dapagliflozin in adults with chronic kidney disease including type 1 diabetes.
- Trial19 Oct 2026Updated FINE-ONE (NCT05901831) with the Phase 3 NEJM primary publication (PMID 41780000, DOI 10.1056/NEJMoa2512854) and the 16 September 2026 FDA supplemental approval of Kerendia (NDA 215341/S-011) for adults with T1D-associated chronic kidney disease.
- Trial19 Oct 2026Corrected the COVALENT-112 trial registry identifier from NCT06514027 (a non-diabetes rectal cancer study) to the verified Biomea Fusion Phase 2b trial NCT06923637 and updated recruitment status to Recruiting (target n=80).
- Trial19 Oct 2026Updated the KIBOU-T1D Japanese Phase 3 teplizumab study (NCT06791291) registry status to Active, not recruiting with actual enrollment of 8 participants.
- Trial19 Oct 2026Added the September 2026 BMJ Open publication (PMID 42767751, PMC13599873) for the Italian STREN longitudinal autoantibody follow-up cohort.
- Trial19 Oct 2026Added the October 2026 Diabetes Care German pediatric stage 2 compassionate-use series (PMID 42520060, PMC13594791) and corrected the US FDA age-1 Stage 2 label extension month to April 2026.
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This view is generated from each record’s review date. As new evidence is ingested and rankings re-scored, updated records rise to the top. How it works →