Full dated editorial ledger. Review depth and source access vary by record; these notes are not independent clinical certification. 121 records appear in this report.
Thriving evidence review — 16 September 2026
Baseline: 27 August 2026. Review date: 16 September 2026. This ledger covers the original 104 records, the initial three additions and the second discovery additions listed below. Other contributors’ additions are documented in separate dated ledgers; the rendered review page combines them.
Each record below identifies the substantive claim scope actually checked against live primary sources. A current review date means that this documented scope was reviewed; it does not mean that every historical clinical percentage, editorial score, country’s stock, payer policy or compatibility combination was independently revalidated. Source availability alone was not counted as claim verification. Registry status, regulatory authorization, manufacturer launch and real-world supply are separate facts. New or retained numerical scores are editorial assessments, not measured probabilities or comparative trial results.
Scope limits are particularly material for older paywalled studies, country-specific access, legacy products and sponsor conference reports. Findings labelled as unresolved remain unresolved; lack of a new announcement is not proof of no change. This is a scoped editorial audit, not certification that all medical content is fully current.
abbott-instinct
Record: Instinct sensor (made by Abbott, sold by MiniMed)
Scope and findings:
- Read September company launch/pipeline announcement; corrected timing/European access and separated submission, CE marking, enrollment and approval. No new efficacy inferred.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
abbott-lingo
Record: Abbott Lingo
Scope and findings:
- ManufacturerUSSeptember2024launchandUKproductpageconfirmconsumerwellnessnoninsulinpositioning. FDAtechnicalspecPDF notyetparsedinthispass; no newperformanceclaim.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
accu-chek-solo
Record: Accu-Chek Solo micropump
Scope and findings:
- Read FDA record: Solo ACE clearance August10,2023. NDSS June30 withdrawal names tubed Roche consumables, not Solo components; cannot prove global Solo discontinuation. UK support page retrieved without usable content; ongoing individual EU-market Solo supply remains unresolved.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
aidanet
Record: AIDANET fully closed-loop algorithm
Scope and findings:
- Registry protocol/status/outcome scope checked; NCT06041971: ACTIVE_NOT_RECRUITING, primary completion {'date': '2024-10-20', 'type': 'ACTUAL'}, {'count': 36, 'type': 'ESTIMATED'}; NCT07039617: RECRUITING, primary completion {'date': '2026-07-31', 'type': 'ESTIMATED'}, {'count': 40, 'type': 'ESTIMATED'}. No new results inferred from completion dates; product approval/access and older clinical scores are separate checks.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
androidaps
Record: AndroidAPS
Scope and findings:
- LatestofficialAAPS3.4.2.6verified;otherDIYOmnipod5statuscorrectedfrombetatoreleased. Releasechangesnotclinicaloutcomeevidence.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
arecor-at247
Record: AT247 ultra-rapid insulin
Scope and findings:
- Read primary2025 interim slides: AT247 Phase1 completed, in-vitro AID modeling. Current portfolio focuses on AT278; absence of AT247 is not evidence of discontinuation. No fresh AT247 clinical start, phase 3 or approval established; detailed2022 PK claims not reread.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
arecor-at278
Record: AT278 (U500 ultra-rapid insulin aspart)
Scope and findings:
- AddedmissedonlineJuly30T2pharmacologypaper,notOctoberfuturedata;scopekeptdistinctfromT1DandAID. CurrentportfoliopreparatorySequelphase2workverified.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
beta-bionics-ilet
Record: Beta Bionics iLet Bionic Pancreas
Scope and findings:
- Added conditional Q4 Eversense 365–iLet partnership milestone; no current shipping/approved pairing claim.
- Added conditional 3D Intelligence submission; distinguished current iLet from uncleared next-generation algorithm.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
beta-bionics-mint
Record: Beta Bionics Mint (patch pump)
Scope and findings:
- Pump FDA clearance announced 14 September; Q1 2027 commercialization target replaces Q2. Separate 3D Intelligence submission remains pending; no current access or new algorithm efficacy inferred. All contradictory display fields and body replaced.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
bigfoot-unity
Record: Bigfoot Unity connected pen-cap system
Scope and findings:
- Read dose-advice functionality and live open Class II recall: selected pen caps with firmware1.3.0 can freeze; affected caps must be returned. Existing recall scope retained; insurer coverage not guaranteed.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
biochaperone-lispro
Record: BioChaperone Lispro (THDB0206)
Scope and findings:
- ReadQ2PDF:filingstillinpreparation,T2dataset1040 separatefromT1;Sep1newsboardchange only. Noverifiedfilingorapproval.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
biolinq-shine
Record: Biolinq Shine
Scope and findings:
- Read FDA De Novo summary: prescription glucose-range monitor, age 22+, not insulin users, no discrete glucose number or hypoglycemia detection. Confirmed record distinguishes this from insulin-dosing CGM. Launch supply not established.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
cadisegliatin
Record: Cadisegliatin (oral glucokinase activator)
Scope and findings:
- Live status/dates150,CATT1active-notrecruitingApril2027,Hybrid40notyetrecruitingApril2027 compared againstAug6companyQ3enrollment/yearendHybridguidance. No new efficacy readout found on current sponsor press list; old phase 2 efficacy not rechecked.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
camaps-fx
Record: CamAPS FX
Scope and findings:
- AddedLibertywithrestrictedindication andcountryrollout. Keptstandardhybridoutcomes/scoringseparate. CamAPSFXcorrectedlongstandingfalse noFDAclearance claim.
- Substantive software support review: August 31 Android version retirement and September notices. Country and pump variants distinguished; clinical performance and global supply not revalidated by this check.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
camaps-liberty
Record: CamAPS Liberty
Scope and findings:
- Added omitted real commerciallylaunched fullyclosedloop mode; namedcountries/date,age 13+,notpregnancy,smallpredecessorstudiesversusnonautomatedCGM/pump; allscores explicitlyeditorial; manufacturer survey separated fromoutcomes.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
cequr-simplicity
Record: CeQur Simplicity wearable bolus patch
Scope and findings:
- Read live manufacturer FAQ and FDA clearance letter. Commercial FAQ describes bolus-only,2-unit increments,4-day wear; separate later clearance must not be treated as proof of new hardware shipping. Full PDF scanned specification annex was not text-readable.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
concept-fully-tubeless-extended-wear-pump
Record: Concept: fully closed-loop extended-wear patch pump
Scope and findings:
- Read posted registry results: small crossover clamp study and separate pivotal extended-wear study. Corrected blanket claim that all seven-day sets lose25% of insulin delivery; exposure is not delivered volume. Detailed historical paper percentages not fully revalidated after PMC access changed to CAPTCHA; no new concept launch date established.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
concept-ketone-cgm
Record: Concept: closed loops that act on ketones
Scope and findings:
- FDA/Abbottdualglucoseketoneauthorizationandlivecomingsoonpageverified. No verifiedcommercialAIDketonecontrol; conceptualresponsepolicy remainsseparatefromsensorclearance.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
concept-stable-glucagon-patch
Record: Concept: compact dual-hormone patch with stable glucagon
Scope and findings:
- Read Q2 2026 SEC filing: first integrated feasibility trial Q4 2025 and additional trial Q1 2026; further excipient and dosing-algorithm improvements identified. Supports early research, not pivotal readiness. Historical dasiglucagon and successor Xeris formulation distinguished; no new trial date established.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
concept-ultrafast-insulin
Record: Concept: sub-20-minute glucose-responsive mealtime insulin
Scope and findings:
- Corrected impossible description of an animal-only result as in-human; distinguished aspirationalcombinedprofile fromactualphase1classprogress.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
control-iq
Record: Tandem Control-IQ
Scope and findings:
- Checked successor Control-IQ+ manufacturer page and older t:connect correction. Kept foundational Control-IQ evidence separate from expanded successor labeling; country-specific installed software and legacy supply not established.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
control-iq-plus
Record: Tandem Control-IQ+
Scope and findings:
- Read current manufacturer labeling: T1D2+, T2D18+, at least5U/day and 9kg; adaptive basal and up-to-hourly automatic correction boluses. Age indication does not override sensor/pump compatibility. Historical all-cohort performance not independently reanalysed.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
ct-868-acmopatide
Record: CT-868 (acmopatide)
Scope and findings:
- Corrected primary PDF table misreading: removed from phase II, not new to phase III. Development discontinued; maturity/access editorial scores reduced from 52/5 to 35/0 to match evidence/access. Conference outcomes not newly independently validated.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
dasiglucagon-bihormonal-pump
Record: Dasiglucagon stable-glucagon infusion for bihormonal AID
Scope and findings:
- Registry protocol/status/outcome scope checked; NCT05454709: WITHDRAWN, primary completion {'date': '2023-12-29', 'type': 'ESTIMATED'}, {'count': 0, 'type': 'ACTUAL'}. No new results inferred from completion dates; product approval/access and older clinical scores are separate checks.
- Read Q2 2026 SEC filing: first integrated feasibility trial Q4 2025 and additional trial Q1 2026; further excipient and dosing-algorithm improvements identified. Supports early research, not pivotal readiness. Historical dasiglucagon and successor Xeris formulation distinguished; no new trial date established.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
dexcom-g6
Record: Dexcom G6
Scope and findings:
- Manufacturer transitionpage explicitly endsmanufacturingafterJuly1; residualstockuncertain. CurrentFDAreceiverrecall record read; phaseoutdistinctfromrecall. No new recallhorizonclaim in item.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
dexcom-g7
Record: Dexcom G7
Scope and findings:
- Verified affected iOS versions and software correction mechanism against live Medsafe database (updated September 11). Added omitted ONE+ correction; G7 notices retained. Not a fresh independent accuracy comparison or exhaustive global recall search.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
dexcom-g7-15-day
Record: Dexcom G7 15-Day
Scope and findings:
- Verified affected iOS versions and software correction mechanism against live Medsafe database (updated September 11). Added omitted ONE+ correction; G7 notices retained. Not a fresh independent accuracy comparison or exhaustive global recall search.
- Read FDA decision summary: 15-day system indicated for adults 18+, with compatible connected-device limitations. Full-wear survival and MARD remain population-level study estimates, not guaranteed individual duration.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
dexcom-g8
Record: Dexcom G8
Scope and findings:
- Read primary May 2026 investor slides29–30: self-adapting electronics/algorithm and late2027/early2028 expected launch. No numeric MARD or cleared product inferred. Detailed submission timing and later conference commentary not independently confirmed.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
dexcom-one-plus
Record: Dexcom ONE+
Scope and findings:
- Verified affected iOS versions and software correction mechanism against live Medsafe database (updated September 11). Added omitted ONE+ correction; G7 notices retained. Not a fresh independent accuracy comparison or exhaustive global recall search.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
dexcom-stelo
Record: Dexcom Stelo
Scope and findings:
- FDAJune12pediatricOTCclearanceages2+verified;livepurchasestorestill18+noninsulin. Existingdistinctionbetweenregulatoryageandcommercialaccessretained. Noinsulindosingindication.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
diabeloop-dblg1
Record: Diabeloop DBLG1
Scope and findings:
- Read successor rollout primary release; confirms DBLG2 smartphone pathway is distinct from DBLG1 dedicated controller. Narrow current product-generation check; original DBLG1 clinical papers and ongoing supply not fully revalidated.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
diabeloop-dblg2
Final link check: replaced the obsolete Sequel announcement path with the matching official 13 January 2026 release. This is a URL repair, not evidence that the planned pairing has launched.
Record: Diabeloop DBLG2
Scope and findings:
- Read July10 official prescription launch: Germany, Android, Kaleido/G7. Current Kaleido site still says Netherlands later2026, so earlier summer target is not proof of launch. iOS remains future; older DBLG1 outcomes do not directly validate DBLG2.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
diaconn-p8
Record: DIA:CONN P8 smart insulin pen
Scope and findings:
- Read manufacturer capacity/increments and full retrospective42-person study. Both groups received intensive education; 21 SIP users improved TIR 47.8 to 70.8, nonrandomized confounding limits device-only attribution. Separate registered randomized trial results not established.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
diasome-hdv-insulin-lispro
Record: HDV-Insulin Lispro (hepatocyte-directed vesicle)
Scope and findings:
- Corrected omitted failed compositeprimaryendpoint;secondarymaintenancehypoglycemia findings and nonsignificant severeeventcomparison distinguished. Sponsor reports226,registry227; not peer-revieweddefinitiveefficacy.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
eoflow-eopatch-glucomen-day
Record: EOFlow EOPatch (GlucoMen Day PUMP)
Scope and findings:
- Read US appellate majority opinion: judgment reversed on statute of limitations, not a finding of no misappropriation. This US ruling does not determine European patent injunctions. Current UPC appeal/market-specific supply remains unverified, so no global availability restoration inferred.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
eversense-365
Record: Senseonics Eversense 365
Scope and findings:
- Corrected DIY compatibility; distinguishes manufacturer-approved pairing from community support. Other product claims not fully re-audited by this compatibility check.
- Updated conference-only status to peer-reviewed manufacturer-authored RWE; corrected sensors vs people, mixed diabetes population, median wear and lack of accuracy/safety comparator. No score increase from publication alone.
- Added conditional Q4 Eversense 365–iLet partnership milestone; no current shipping/approved pairing claim.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
faster-aspart
Record: Faster aspart (Fiasp)
Scope and findings:
- EMA current EPAR confirms aspart formulation,meal window,pump route and similar HbA1c with postprandial advantages versusNovoRapid; pump must also label the insulin. Exact US costs and every clamp numerical estimate not newly checked.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
finerenone-t1d-ckd
Record: Finerenone (Kerendia) for T1D kidney disease
Scope and findings:
- Primary company release confirms priorityreview,T1DCKDindication investigational,UACRsurrogate6 months;registrycompleted241. Septemberhorizon found non-diabeticFINDCKD update,notT1approval. Existing correctsurrogate caveat retained; no newhardoutcomeclaim.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
freestyle-libre-2-plus
Record: FreeStyle Libre 2 Plus
Scope and findings:
- Read 15-day sensor study and current US prescribing page. Supports age 2+, 15 days and minute streaming; Plus systems share sensor design. Regional app, reader and AID compatibility must be checked separately.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
freestyle-libre-3-plus
Record: FreeStyle Libre 3 Plus
Scope and findings:
- Corrected DIY compatibility; distinguishes manufacturer-approved pairing from community support. Other product claims not fully re-audited by this compatibility check.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
fully-closed-loop-insulin-only-concept
Record: Fully closed-loop, insulin-only (no meal announcement)
Scope and findings:
- Correctedclass-wideinvestigational-only implication afterLibertylaunch;retainedresearchoverviewseparatefromnewproduct. Historicalcross-studycomparisonsremainlimited.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
glucose-responsive-insulin
Record: Glucose-responsive ("smart") insulin
Scope and findings:
- Live registry states recruiting118/completed 117/completed 36 with no posted results. These supporthumanphase1status,notoutpatient efficacy or publishedglucose response.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
glucotrack-implantable-cbgm
Record: Glucotrack implantable CBGM
Scope and findings:
- Read May 7 IDE submission announcement; submission is not FDA study authorization or product clearance. No later IDE decision or commercial launch verified; sponsor-site source replaces blocked wire access.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
iaps
Record: iAPS
Scope and findings:
- Verified latest official release v8.3.6 and its initialization-race hotfix. Corrected impossible iPhone 8/iOS 17 combination without claiming an unsupported exact oldest model.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
ilet-bihormonal-dasiglucagon
Record: Beta Bionics iLet — bihormonal (insulin + dasiglucagon)
Scope and findings:
- Read Q2 2026 SEC filing: first integrated feasibility trial Q4 2025 and additional trial Q1 2026; further excipient and dosing-algorithm improvements identified. Supports early research, not pivotal readiness. Historical dasiglucagon and successor Xeris formulation distinguished; no new trial date established.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
ilet-bionic-pancreas
Record: Beta Bionics iLet Bionic Pancreas
Scope and findings:
- Added conditional Q4 Eversense 365–iLet partnership milestone; no current shipping/approved pairing claim.
- Added conditional 3D Intelligence submission; distinguished current iLet from uncleared next-generation algorithm.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
indigo-halo-cmm
Record: Indigo HALO continuous multi-metabolite monitor
Scope and findings:
- ManufacturerexplicitnotFDAcleared/notCEmarked/notforsale;PLOSprimary7personfeasibility(glucoseMARD7.4%,4T1D)andnew12personHALOBRIGHTnotyetrecruitingJune2027completionverified. NotyearlongT1Defficacy.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
inhaled-insulin
Record: Inhaled insulin (Afrezza)
Scope and findings:
- Read current FDA prescribing information; added pediatric missed noninferiority endpoint, group sizes, CI and limited safety counts. Adult outcomes and access not independently rechecked in this pass.
- Corrected US-only availability. US pediatric 6+ approval is not extended to India/Brazil by inference. Region enum does not represent these two markets; body/rationale disclose them.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
inreda-ap
Record: Inreda AP (dual-hormone)
Scope and findings:
- Read published PANORAMA abstract: 34 randomized,20 primary-analysis completers, TIR 81/57, TBR0.9/1.2 with CI crossing zero. Added separate-population caveat. Current manufacturer supports CE AP5/project-only access, AP6 development, daily glucagon refill; removed unsupported single-insurer certainty.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
insulet-omnipod-6
Record: Omnipod 6 (pump)
Scope and findings:
- Registry protocol/status/outcome scope checked; NCT07579702: RECRUITING, primary completion {'date': '2027-02-22', 'type': 'ESTIMATED'}, {'count': 200, 'type': 'ESTIMATED'}. No new results inferred from completion dates; product approval/access and older clinical scores are separate checks.
- Read STRIVE primary sponsor report: 132 total,98 T1D; 77% versus 73% is specifically T1D age 14+, not entire pediatric cohort. EVOLUTION3 is T2D; early T1D fully closed-loop work is explicitly announced, correcting prior blanket denial. Sponsor release is not a full peer-reviewed report.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
insulin-aspart
Record: Insulin aspart (NovoLog / NovoRapid)
Scope and findings:
- US label confirms rapid analogue,1–3h glucose-effect peak,3–5h duration,40–50min serum peak,81min apparent half-life and pump-specific instructions. Removed blanket halve-dose exercise advice. Biosimilar/price/Cochrane claims need separate source review.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
insulin-degludec
Record: Insulin degludec (Tresiba)
Scope and findings:
- US label indication age 1+,42-hour clamp activity,25-hour half-life,3–4-day steady state and adult/pediatric dose-timing distinction verified. Removed absolute no-gap/no-stacking reassurance and categorical exercise dose advice. Global prices and comparative trial estimates not independently reverified.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
insulin-efsitora-alfa
Record: Insulin efsitora alfa (basal Fc)
Scope and findings:
- EMA Onswik remains positiveCHMPopinion25 June 2026,adultT2only;NICE T1 projectdiscontinued30 July 2026. NoECdecision posted on retrievedEPAR. RegistryQWINT5 completed 692. No newT1approval established.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
insulin-glargine-u100
Record: Insulin glargine U100 (Lantus + biosimilars)
Scope and findings:
- Read live FDA biosimilar record and primary payer shortage bulletin. Added missed2026 Langlara approval and regional SoloStar supply caveat. Historical basal PK/comparative efficacy and every-market supply not freshly established.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
insulin-glargine-u300
Record: Insulin glargine U300 (Toujeo)
Scope and findings:
- Read DailyMed/EMA: U300 not interchangeable withU100;steady state>=5days,onset develops over6h,unit-for-unit glucose effect lower;adult/pediatric use. Comparative benefits and regional prices not newly reverified.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
insulin-glulisine
Record: Insulin glulisine (Apidra)
Scope and findings:
- US label confirms rapid human analogue,60min median serum peak,42min apparent half-life,meal window and pump compatibility contingent on pump IFU. EMA authorization retained. Pump occlusion comparative evidence and prices not newly reverified.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
insulin-icodec
Record: Once-weekly insulin icodec (Awiqli)
Scope and findings:
- EMA Awiqli EPAR confirms adultT1/T2 authorization and higher hypoglycemia inT1;T1 initiation only with clear weekly-dosing benefit. Does not establish all-market availability or US indication.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
insulin-lispro
Record: Insulin lispro (Humalog)
Scope and findings:
- Read label PK/PD:30–90min serum peak,variable person/site/activity response and more rapid onset/shorter duration than regular insulin. The cited DailyMed label is historical; current regional availability and price claims not established by it.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
insulin-nph
Record: NPH insulin (isophane / Humulin N / Novolin N)
Scope and findings:
- Read current HumulinN and NovolinN labels: intermediate action,median Humulin maximal glucose effect6.5h(range2.8–13),variable Novolin duration up to 24h,onset1–2h; resuspension/storage product-specific. Unqualified cheapest claim softened because prices and coverage vary.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
insulin-pramlintide-closed-loop
Record: Insulin + pramlintide (amylin) closed loop
Scope and findings:
- Read publisher-deposited ADA abstract. Corrected publication status; removed unverified subgroup and nausea-withdrawal claims and unsupported program-abandonment inference. Noninferiority was not achieved despite similar means. Registry UNKNOWN does not prove recruitment.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
insulin-pramlintide-coformulation
Record: Co-formulated insulin + pramlintide (single-reservoir)
Scope and findings:
- ReadQ2AdociaPDF: M1Pramdevelopmentputonhold afterJuly3Sanofiexclusivityexpiration,rightsretained. Existingholdstatus confirmed; notglobalpramlintidewithdrawal.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
kaleido-pump
Record: Kaleido patch pump
Scope and findings:
- Read current manufacturer: 5/30cm tubing, patch-or-pocket wear, DBLG2/G7/Android Germany, Netherlands later2026. Does not establish Dutch DBLG2 shipping, iOS release or FDA pump commercialization.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
libre-duo
Record: Abbott Libre Duo
Scope and findings:
- LiveAbbottUSproductpage sayscomingsoon;FDAAug25authorizationages2+ verified,companyCEandUSnoticeseparatelyread. Keptpipelineversuslaunchdistinction.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
libre-rio
Record: FreeStyle Libre Rio
Scope and findings:
- FDA 510krecordandAbbottclearanceannouncementconfirmadultnoninsulinT2OTCscope. Retrievedcorporatenewsheadline sayslaunchbutarticlebodydescribesclearance/futureproduct; commerciallaunchnotindependentlyestablished. Existingavailabilityshouldnotbeassumedfromheadline.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
lilly-tempo
Record: Lilly Tempo connected-insulin platform
Scope and findings:
- Read manufacturer/Welldoc FAQ: platform ends by end2026; no new data to Insights after July27; export triggers read-only mode then account deletion after30days. GUDID distribution-end November25 is a separate device field, not platform shutdown date. Homepage redirect does not itself verify withdrawal.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
loop-diy
Record: Loop (iOS)
Scope and findings:
- Official released compatibility reviewed; removed obsolete open-beta/coming-soon claims. Clinical score numbers unchanged; release is not a clinical outcome trial.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
medtronic-guardian-4
Record: Medtronic Guardian 4
Scope and findings:
- Read clinical continued-access and real-world paper: 176 continued-access participants and 36,303 real-world users, calibration-free Guardian 4 with 780G; reported pivotal MARD 10.8%. Cross-study MARD is not a head-to-head sensor ranking; regional stock not checked.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
medtronic-minimed-780g
Record: Medtronic MiniMed 780G (pump)
Scope and findings:
- Read September company launch/pipeline announcement; corrected timing/European access and separated submission, CE marking, enrollment and approval. No new efficacy inferred.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
medtronic-minimed-fit
Record: MiniMed Fit (patch pump)
Scope and findings:
- Read September company launch/pipeline announcement; corrected timing/European access and separated submission, CE marking, enrollment and approval. No new efficacy inferred.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
medtronic-minimed-flex
Record: MiniMed Flex pump
Scope and findings:
- Read September company launch/pipeline announcement; corrected timing/European access and separated submission, CE marking, enrollment and approval. No new efficacy inferred.
- Live GATEWAY registry status ACTIVE_NOT_RECRUITING, actual 389, estimated primary/completion January 2027; updated enrollment language independently of company Vivera milestone.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
medtronic-simplera
Record: Medtronic Simplera (standalone)
Scope and findings:
- Read current US MiniMed Go labeling: Simplera configuration18+, Instinct configuration7+ or2–6 with caregiver. Sensors are not interchangeable merely because both connect to Go. Independent comparative accuracy papers were blocked in this run and are not newly verified.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
medtrum-touchcare-300u
Record: Medtrum TouchCare Nano 300U patch pump
Scope and findings:
- Read current200U/300U manufacturer specifications and July German launch-progress/GKV-listing notice. Country models differ; directory listing and presentation are not proof of completed German commercial rollout. No independent head-to-head reliability check.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
medtrum-touchcare-nano-aid
Record: Medtrum TouchCare Nano
Scope and findings:
- Registry protocol/status/outcome scope checked; NCT06363916: UNKNOWN, primary completion {'date': '2025-11', 'type': 'ESTIMATED'}, {'count': 160, 'type': 'ESTIMATED'}. No new results inferred from completion dates; product approval/access and older clinical scores are separate checks.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
minimed-670g
Record: Medtronic MiniMed 670G (first hybrid closed loop)
Scope and findings:
- Read FDA 2018 expanded indication: T1D7+, Guardian3 adjunctive fingerstick-based treatment adjustment, automated basal only. Narrow historical label check; current legacy consumable supply, discontinuation and all safety notices not fully established.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
minimed-780g
Record: Medtronic MiniMed 780G (SmartGuard)
Scope and findings:
- Read September company launch/pipeline announcement; corrected timing/European access and separated submission, CE marking, enrollment and approval. No new efficacy inferred.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
minimed-go
Record: MiniMed Go / InPen smart MDI system
Scope and findings:
- Read September company launch/pipeline announcement; corrected timing/European access and separated submission, CE marking, enrollment and approval. No new efficacy inferred.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
minimed-nmx8-aid
Record: MiniMed Flex (formerly NMX8-AID)
Scope and findings:
- Read September company launch/pipeline announcement; corrected timing/European access and separated submission, CE marking, enrollment and approval. No new efficacy inferred.
- Live GATEWAY registry status ACTIVE_NOT_RECRUITING, actual 389, estimated primary/completion January 2027; updated enrollment language independently of company Vivera milestone.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
minimed-vivera
Record: MiniMed Vivera (next-generation SmartGuard algorithm)
Scope and findings:
- Read September company launch/pipeline announcement; corrected timing/European access and separated submission, CE marking, enrollment and approval. No new efficacy inferred.
- Live GATEWAY registry status ACTIVE_NOT_RECRUITING, actual 389, estimated primary/completion January 2027; updated enrollment language independently of company Vivera milestone.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
modular-medical-pivot
Record: Modular Medical Pivot patch pump
Scope and findings:
- Read manufacturer April9 and June24 releases:3mL removabletwo-partpump,USclearance and phasedcommercialavailability,Q4expansion,targetfutureACE/AID. Current patient stock and independent outcomes not verified.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
noninvasive-glucose-monitoring
Record: Non-invasive glucose monitoring (Apple, Samsung, Know Labs, Afon Glucowear)
Scope and findings:
- Rechecked FDA no-authorized-watch/ring warning and calibration-dependent Raman research in type 2 diabetes. Does not establish a dosing-authorized noninvasive T1D CGM. Future Apple timing is external speculation, not primary verification.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
novopen-6-echo-plus
Record: NovoPen 6 / NovoPen Echo Plus
Scope and findings:
- Read current manufacturer page: 800 stored dose events include flow checks; NFC download, not automated delivery. Corrected dose-memory wording; country stock and reimbursement not independently verified.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
omnipod-5
Record: Omnipod 5 (pump)
Scope and findings:
- Corrected DIY compatibility; distinguishes manufacturer-approved pairing from community support. Other product claims not fully re-audited by this compatibility check.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
omnipod-5-aid
Record: Omnipod 5 (SmartAdjust AID)
Scope and findings:
- Read current product page and both2026 FDA pod recall notices. May and March/April affected-lot actions remain distinct; current compatibility is configuration-specific. No new head-to-head clinical comparison or every-country rollout verified.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
omnipod-6-aid
Record: Omnipod 6 (AID)
Scope and findings:
- Registry protocol/status/outcome scope checked; NCT07579702: RECRUITING, primary completion {'date': '2027-02-22', 'type': 'ESTIMATED'}, {'count': 200, 'type': 'ESTIMATED'}; NCT06865989: COMPLETED, primary completion {'date': '2025-11-10', 'type': 'ACTUAL'}, {'count': 132, 'type': 'ACTUAL'}. No new results inferred from completion dates; product approval/access and older clinical scores are separate checks.
- Read STRIVE primary sponsor report: 132 total,98 T1D; 77% versus 73% is specifically T1D age 14+, not entire pediatric cohort. EVOLUTION3 is T2D; early T1D fully closed-loop work is explicitly announced, correcting prior blanket denial. Sponsor release is not a full peer-reviewed report.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
omnipod-dash
Record: Omnipod DASH (pump)
Scope and findings:
- Read FDA May26 affected-lot recall and official AndroidAPS DASH documentation. Recall is lot-specific and requires replacement of affected pods; community interoperability is not manufacturer-approved AID. Older comparative outcome papers were not accessible.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
omnipod-go
Record: Omnipod GO (pump)
Scope and findings:
- Read current filed10-K: company decided not to commercialize basal-only Omnipod GO following pilot, with2024 inventory charge. Historic FDA clearance does not mean commercial availability or T1D indication.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
openaps
Record: OpenAPS (oref0)
Scope and findings:
- Officiallatestoref0releasev0.7.1 June 2022confirmedviaGitHubAPI. No newerreleasefound;historicalCREATEandselfreportedoutcomescitationsnotrecheckedinthispass.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
pramlintide-symlin
Record: Pramlintide (Symlin)
Scope and findings:
- New historical record; FDA marketing status checked against DailyMed, discrepancy disclosed; no stock or discontinuation reason inferred.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
roche-accu-chek-smartguide
Record: Accu-Chek SmartGuide
Scope and findings:
- Corrected DIY compatibility; distinguishes manufacturer-approved pairing from community support. Other product claims not fully re-audited by this compatibility check.
- Corrected medically material false factory-calibrated/no-fingersticks claim in summary,body,criteria. Two-step calibration and TrendMode dosingrestriction verified. Calibration score100→65 editorial burden correction (check originalscore in git if needed).
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
semaglutide-t1d-adjunct
Record: Semaglutide as an adjunct in T1D
Scope and findings:
- New evidence-backed item; obesity-label distinction, ketosis, small trials and editorial scores explicit.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
sequel-twiist
Record: twiist (Sequel)
Scope and findings:
- Updated conference-only status to peer-reviewed manufacturer-authored RWE; corrected sensors vs people, mixed diabetes population, median wear and lack of accuracy/safety comparator. No score increase from publication alone.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
sglt2-inhibitors-t1d
Record: SGLT2 / SGLT1-2 inhibitors (dapagliflozin, sotagliflozin)
Scope and findings:
- Correct Q4 resubmission and Gulf heart-failure indications; remove speculative commercial motives and assertion ketone sensors solve all DKA risk. Score numbers unchanged.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
sibionics-gs1
Record: Sibionics GS1
Scope and findings:
- Corrected false exclusion ofEurope and inabilitytoverifyCE:manufacturer2023MDRcertificateannouncement/currentEuropeanstorefront. Countrydependentage3vs18 retainedintext; noFDAoruniversalregionalapprovalinferred.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
sibionics-gs3
Record: SiBionics GS3
Scope and findings:
- ManufacturerGS3product/FAQandAustralianAirLiquidepageconfirm14days,2.9mm,CEclaim,saleandcountrydependentage3vs18. Registryrecruiting36,June 2027primary; noresults. ManufacturerMARDnotindependentcomparison.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
sigi-patch-aid
Record: Next-generation Mobi patch pump (Sigi technology)
Scope and findings:
- Registry protocol/status/outcome scope checked; NCT05973422: UNKNOWN, primary completion {'date': '2024-09-30', 'type': 'ESTIMATED'}, {'count': 10, 'type': 'ESTIMATED'}. No new results inferred from completion dates; product approval/access and older clinical scores are separate checks.
- Read manufacturer pipeline updated August6: Sigi-derived next-generation Mobi is distinct from current Mobi tubeless infusion-site submission; no next-generation launch date.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
sooil-dana-i
Record: SOOIL Dana-i
Scope and findings:
- Substantive software support review: August 31 Android version retirement and September notices. Country and pump variants distinguished; clinical performance and global supply not revalidated by this check.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
sooil-dana-rs
Record: SOOIL Dana Diabecare RS
Scope and findings:
- Substantive software support review: August 31 Android version retirement and September notices. Country and pump variants distinguished; clinical performance and global supply not revalidated by this check.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
tandem-mobi
Record: Tandem Mobi (pump)
Scope and findings:
- Read three open FDA correction records and current product page. Confirmed version-specific stopped-delivery/interpolation/autobolus defects,200U, phone control, G7 15 Day integration. No inference that every current unit has these defects. Historical outcome claims not fully reread.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
tandem-mobi-control-iq
Record: Tandem Mobi (Control-IQ+)
Scope and findings:
- Read current Mobi system specifications and three open FDA correction records; preserved software-specific risk and compatibility distinctions. Foundational Control-IQ outcomes are not a randomized evaluation of Mobi hardware.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
tandem-tslim-x2
Record: Tandem t:slim X2 (pump)
Scope and findings:
- Read four live open correction/recall records: speaker hardware, t:connect battery drain, Control-IQ+7.9 interpolation and G7-session autobolus scopes remain distinct. Current regional corrective software adoption is not measurable from recall open status.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
tirzepatide-t1d-adjunct
Record: Tirzepatide as an adjunct in T1D
Scope and findings:
- Corrected blanket any-T1D-use-offlabel statement: obesity eligibility differs from T1D glycemic indication. Registry dates checked separately below.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
trio
Record: Trio
Scope and findings:
- Official released compatibility reviewed; removed obsolete open-beta/coming-soon claims. Clinical score numbers unchanged; release is not a clinical outcome trial.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
twiist
Record: Sequel twiist
Scope and findings:
- Updated conference-only status to peer-reviewed manufacturer-authored RWE; corrected sensors vs people, mixed diabetes population, median wear and lack of accuracy/safety comparator. No score increase from publication alone.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
ultra-rapid-lispro
Record: Ultra-rapid lispro (Lyumjev)
Scope and findings:
- Read current June 2026 label: mealtime/within20 minutes, U100-only pump/IV, U200pen-only,no syringe transfer. Corrected ambiguous U200vial/IV wording. Exact pump compatibility follows both labels; exercise RCT and global prices not freshly revalidated.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
ypsomed-mylife-ypsopump
Record: Ypsomed mylife YpsoPump (pump)
Scope and findings:
- AddedLibertywithrestrictedindication andcountryrollout. Keptstandardhybridoutcomes/scoringseparate. CamAPSFXcorrectedlongstandingfalse noFDAclearance claim.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
ypsopump-aid-cumulative
Record: Ypsomed mylife Loop (CamAPS FX on YpsoPump)
Scope and findings:
- AddedLibertywithrestrictedindication andcountryrollout. Keptstandardhybridoutcomes/scoringseparate. CamAPSFXcorrectedlongstandingfalse noFDAclearance claim.
- Substantive software support review: August 31 Android version retirement and September notices. Country and pump variants distinguished; clinical performance and global supply not revalidated by this check.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
zucara-zt01
Record: ZT-01 glucagon-response restorer
Scope and findings:
- Registry protocol/status/outcome scope checked; NCT05762107: RECRUITING, primary completion {'date': '2026-12', 'type': 'ESTIMATED'}, {'count': 186, 'type': 'ESTIMATED'}. No new results inferred from completion dates; product approval/access and older clinical scores are separate checks.
Primary sources checked:
Limits: The review is restricted to the scopes above. Historical efficacy estimates, editorial scoring and country-specific access were not fully reverified unless expressly stated. A manufacturer or conference report retains that evidence level.
caresens-air
Record: CareSens Air
Scope and findings: Added in the second discovery pass. A 15-day standalone CGM sold in Australia for adults with diabetes. Current manufacturer specifications describe optional calibration and a 30-minute warm-up; the supplied regional manual takes precedence. Numerical claims are tied to the cited product specifications or named study, and editorial scores do not represent measured comparative performance.
Primary sources checked:
- CareSens Air current specifications
- Pharmaco Australia CareSens Air product and safety information
- TGA ARTG496627, I-Sens CGM sponsored by Pharmaco
- Australian CareSens Air instructions
Limits: Scope is the specific claims documented in the new record. Local stock, payer rules, every hardware variant and unreported head-to-head outcomes are not verified. Regulatory status, manufacturer marketing and clinical performance are distinct.
caresens-air-2
Record: CareSens Air 2
Scope and findings: Added in the second discovery pass. Announced successor to CareSens Air, with launch targeted for early2027. Smaller size, longer wear and a redesigned app are development claims; numerical specifications and clinical performance are not established here. Numerical claims are tied to the cited product specifications or named study, and editorial scores do not represent measured comparative performance.
Primary sources checked:
Limits: Scope is the specific claims documented in the new record. Local stock, payer rules, every hardware variant and unreported head-to-head outcomes are not verified. Regulatory status, manufacturer marketing and clinical performance are distinct.
medtrum-nano-cgm
Record: Medtrum TouchCare Nano CGM
Scope and findings: Added in the second discovery pass. A standalone or Medtrum-pump-integrated CGM with a rechargeable transmitter and up to14-day sensor wear. It reports every two minutes and offers optional calibration. Numerical claims are tied to the cited product specifications or named study, and editorial scores do not represent measured comparative performance.
Primary sources checked:
- Medtrum TouchCare Nano CGM specifications, MD1158/MD3658
- Medtrum UK purchase and NHS access information
Limits: Scope is the specific claims documented in the new record. Local stock, payer rules, every hardware variant and unreported head-to-head outcomes are not verified. Regulatory status, manufacturer marketing and clinical performance are distinct.
microtech-linx
Record: MicroTech LinX
Scope and findings: Added in the second discovery pass. A small standalone CGM with15-day wear. The current EU manual covers diabetes from age2, with age-specific insertion sites. Manufacturer accuracy claims are not treated as head-to-head evidence. Numerical claims are tied to the cited product specifications or named study, and editorial scores do not represent measured comparative performance.
Primary sources checked:
- MicroTech LinX product specifications
- LinX EU user guide V09,24March2026
- MicroTech WHX Miami2026 product update
Limits: Scope is the specific claims documented in the new record. Local stock, payer rules, every hardware variant and unreported head-to-head outcomes are not verified. Regulatory status, manufacturer marketing and clinical performance are distinct.
sinocare-ican-i3
Record: Sinocare iCan i3 / GlucoMen iCan
Scope and findings: Added in the second discovery pass. A15-day standalone CGM sold under regional branding. A2026 pediatric paper reports8.89% MARD in75 per-protocol participants; this does not establish superiority over another CGM or US clearance. Numerical claims are tied to the cited product specifications or named study, and editorial scores do not represent measured comparative performance.
Primary sources checked:
- Sinocare iCan i3 specifications and regional indication
- Wang et al. Pediatric CGM performance study
- Sinocare ADA2026 adult and pediatric reports
- GlucoMen iCan user guide, April2025
- Sinocare product history and i3/i6 launch distinctions
Limits: Scope is the specific claims documented in the new record. Local stock, payer rules, every hardware variant and unreported head-to-head outcomes are not verified. Regulatory status, manufacturer marketing and clinical performance are distinct.
sinocare-ican-i6
Record: Sinocare iCan i6
Scope and findings: Added in the second discovery pass. A smaller iCan CGM family commercialized in China, with15-day wear and three-minute updates. The international page explicitly excludes sales in the UK and many EU countries; those markets are not marked available. Numerical claims are tied to the cited product specifications or named study, and editorial scores do not represent measured comparative performance.
Primary sources checked:
- Sinocare iCan i6 specifications and regional sales restrictions
- Sinocare product history and i3/i6 launch distinctions
Limits: Scope is the specific claims documented in the new record. Local stock, payer rules, every hardware variant and unreported head-to-head outcomes are not verified. Regulatory status, manufacturer marketing and clinical performance are distinct.
microtech-aidex
Record: MicroTech AiDEX
Scope and findings: Added in the second discovery pass. An established CGM family using a separate transmitter and sensor. Current manufacturer specifications describe a one-hour warm-up and optional calibration; model-specific wear life, age labels and local access need confirmation. Numerical claims are tied to the cited product specifications or named study, and editorial scores do not represent measured comparative performance.
Primary sources checked:
- MicroTech AiDEX current product specifications
- MicroTech2023 annual report: Equil and AiDEX marketed internationally
Limits: Scope is the specific claims documented in the new record. Local stock, payer rules, every hardware variant and unreported head-to-head outcomes are not verified. Regulatory status, manufacturer marketing and clinical performance are distinct.
microtech-equil
Record: MicroTech Equil patch pump
Scope and findings: Added in the second discovery pass. An established wearable patch pump with bolus calculation, temporary basal and extended boluses. MicroTech’s developing closed-loop program is separate; no approved AID functionality is inferred for this pump. Numerical claims are tied to the cited product specifications or named study, and editorial scores do not represent measured comparative performance.
Primary sources checked:
- MicroTech Equil patch insulin pump specifications
- MicroTech2023 annual report: Equil and AiDEX marketed internationally
- MicroTech June2026 commercial products and developing closed-loop system
Limits: Scope is the specific claims documented in the new record. Local stock, payer rules, every hardware variant and unreported head-to-head outcomes are not verified. Regulatory status, manufacturer marketing and clinical performance are distinct.
metformin-t1d-adjunct
Record: Metformin as an adjunct in T1D
Scope and findings: Added in the second discovery pass. An off-label adjunct with modest weight effects but no sustained glucose-control benefit in the large REMOVAL trial. It remains alongside insulin, with tolerability and patient selection limiting its role. Numerical claims are tied to the cited product specifications or named study, and editorial scores do not represent measured comparative performance.
Primary sources checked:
Limits: Scope is the specific claims documented in the new record. Local stock, payer rules, every hardware variant and unreported head-to-head outcomes are not verified. Regulatory status, manufacturer marketing and clinical performance are distinct.
liraglutide-t1d-adjunct
Record: Liraglutide as an adjunct in T1D
Scope and findings: Added in the second discovery pass. Daily GLP-1 therapy studied as an adjunct to insulin in large T1D trials. Modest HbA1c and weight benefits were accompanied by more symptomatic hypoglycemia and hyperglycemia with ketosis; T1D use is off-label. Numerical claims are tied to the cited product specifications or named study, and editorial scores do not represent measured comparative performance.
Primary sources checked:
Limits: Scope is the specific claims documented in the new record. Local stock, payer rules, every hardware variant and unreported head-to-head outcomes are not verified. Regulatory status, manufacturer marketing and clinical performance are distinct.
insulin-detemir
Record: Insulin detemir (Levemir)
Scope and findings: Added in the second discovery pass. An established basal insulin being phased out. Australian and Dutch presentations are scheduled to end in December2026; the US brand is already on FDA’s discontinued list. Remaining stock must be checked locally. Numerical claims are tied to the cited product specifications or named study, and editorial scores do not represent measured comparative performance.
Primary sources checked:
- Levemir prescribing information
- TGA current insulin supply changes
- FDA discontinued biologic product list, April2026
- Novo Nordisk Netherlands portfolio phase-out dates
Limits: Scope is the specific claims documented in the new record. Local stock, payer rules, every hardware variant and unreported head-to-head outcomes are not verified. Regulatory status, manufacturer marketing and clinical performance are distinct.
insulin-regular-human
Record: Regular human insulin U100 (Humulin R / Actrapid)
Scope and findings: Added in the second discovery pass. Established short-acting human insulin. Its slower meal timing differs from rapid analogues; presentation-specific withdrawals in Australia do not mean all regular human insulin is discontinued worldwide. Numerical claims are tied to the cited product specifications or named study, and editorial scores do not represent measured comparative performance.
Primary sources checked:
- Humulin R U100 US prescribing information
- TGA current insulin supply changes
- Lilly current medicines catalogue
Limits: Scope is the specific claims documented in the new record. Local stock, payer rules, every hardware variant and unreported head-to-head outcomes are not verified. Regulatory status, manufacturer marketing and clinical performance are distinct.
microtech-closed-loop
Record: MicroTech closed-loop artificial pancreas
Scope and findings: Manufacturer June2026 release and current program page establish a developing closed-loop product, separate from commercial Equil/LinX products. No numerical efficacy, exact device pairing, approved indication or launch date verified.
Primary sources checked:
Limits: Program identity and development claim only. Scores are explicit provisional editorial assessments, not measured trial outcomes.
caresens-air-3
Record: CareSens Air 3
Scope and findings: Read live-registry cache for NCT07296276. Estimated 32 participants, recruiting, last update 9 April 2026, estimated completion 30 April 2026 elapsed; no posted results. No inference of completion or Air 2 equivalence.
Primary sources checked:
Limits: Registry posting can lag actual activity. Final specifications, approval and relationship to Air 2 unresolved; scores are provisional editorial assessments.
dexcom-g8
Additional second-pass scope: Replaced secondary/syndicated evidence with direct investor slides; removed inherited age2, unconfirmed12-hour grace and unsupported submission specifics. Manufacturer data-on-file improvement distinguished from public numerical accuracy dataset. All scores marked provisional, current access0 and ketones0.
Primary sources checked:
Limits: Only the specific claims and scoring interpretation above were revisited. This does not revalidate every historical outcome or regional access claim.
camaps-fx
Additional second-pass scope: AiDAPT10.5pp explicitly adjusted, not raw subtraction. Boost/Ease-off paper supports observed lower TAR but user-selected retrospective modes do not prove causality; retained accurately attributed no-SHE/DKA statement.
Primary sources checked:
Limits: Only the specific claims and scoring interpretation above were revisited. This does not revalidate every historical outcome or regional access claim.
omnipod-6-aid
Additional second-pass scope: Unreleased-product scores explicitly provisional; commercial access0; removed trial-entry age from approved-age field. Omnipod6 TIR remains observed sponsor-reported33-person age14+ T1D subgroup, not all132randomized participants.
Primary sources checked:
Limits: Only the specific claims and scoring interpretation above were revisited. This does not revalidate every historical outcome or regional access claim.
insulet-omnipod-6
Additional second-pass scope: Unreleased-product scores explicitly provisional; commercial access0; removed trial-entry age from approved-age field. Omnipod6 TIR remains observed sponsor-reported33-person age14+ T1D subgroup, not all132randomized participants.
Primary sources checked:
Limits: Only the specific claims and scoring interpretation above were revisited. This does not revalidate every historical outcome or regional access claim.
minimed-vivera
Additional second-pass scope: Unreleased-product scores explicitly provisional; commercial access0; removed trial-entry age from approved-age field. Omnipod6 TIR remains observed sponsor-reported33-person age14+ T1D subgroup, not all132randomized participants.
Primary sources checked:
Limits: Only the specific claims and scoring interpretation above were revisited. This does not revalidate every historical outcome or regional access claim.
medtronic-minimed-fit
Additional second-pass scope: Unreleased-product scores explicitly provisional; commercial access0; removed trial-entry age from approved-age field. Omnipod6 TIR remains observed sponsor-reported33-person age14+ T1D subgroup, not all132randomized participants.
Primary sources checked:
Limits: Only the specific claims and scoring interpretation above were revisited. This does not revalidate every historical outcome or regional access claim.
metformin-t1d-adjunct
Additional label scope: Current DailyMed label inspected for type2 indication, renal/acidosis contraindications, lactic-acidosis boxed warning and vitaminB12 monitoring. Added these safety caveats without replacing REMOVAL trial-specific findings.
Limits: Local prescribing and stock not verified.
caresens-air
Final source repair and substantive check: The retired Australian /Media/ manual URL returned 404. Followed the current manual link from the official Pharmaco product page to its Shopify-hosted PDF, downloaded it successfully (HTTP 200, application/pdf), and inspected the content. Page 12 confirms diabetes age 18+ and exclusions for children, pregnancy/breastfeeding, dialysis and critical illness; page 53 confirms 30-minute warm-up; page 106 confirms optional calibration. Existing clinical statements remain supported.
Primary sources checked:
Limits: This repairs and verifies the regional manual citation; it does not establish reimbursement or local stock.
diabeloop-dblg1
Additional ranking review, 16 September 2026. Checked outcome attribution, generation differences, cohort comparability and criterion rationale against primary sources. Corrected false claims and added measured/provisional distinctions. Full findings and source-specific limits are in the AID ranking evidence audit. Numerical ratings were left to the central scoring calibration.
- https://doi.org/10.1111/dom.15008
- https://doi.org/10.1111/dom.14442
- https://doi.org/10.1177/19322968251404493
- https://www.accu-chek.es/productos/sistema-hibrido-asa-cerrada/insight-dblg1
diabeloop-dblg2
Additional ranking review, 16 September 2026. Checked outcome attribution, generation differences, cohort comparability and criterion rationale against primary sources. Corrected false claims and added measured/provisional distinctions. Full findings and source-specific limits are in the AID ranking evidence audit. Numerical ratings were left to the central scoring calibration.
- https://www.accessdata.fda.gov/cdrh_docs/reviews/K251152.pdf
- https://www.diabeloop.com/news/health-sector/dblg2-manage-unexpected-glycemic-excursions
- https://doi.org/10.1177/19322968251404493
omnipod-5-aid
Additional ranking review, 16 September 2026. Checked outcome attribution, generation differences, cohort comparability and criterion rationale against primary sources. Corrected false claims and added measured/provisional distinctions. Full findings and source-specific limits are in the AID ranking evidence audit. Numerical ratings were left to the central scoring calibration.
- https://doi.org/10.2337/dc21-0172
- https://doi.org/10.2337/dc25-0141
- https://www.omnipod.com/hcp/algorithm-enhancement-faq
- https://www.omnipod.com/en-au/hcp/products/omnipod-5-system
omnipod-6-aid
Additional ranking review, 16 September 2026. Checked outcome attribution, generation differences, cohort comparability and criterion rationale against primary sources. Corrected false claims and added measured/provisional distinctions. Full findings and source-specific limits are in the AID ranking evidence audit. Numerical ratings were left to the central scoring calibration.
- https://clinicaltrials.gov/study/NCT06865989
- https://investor.insulet.com/news/news-details/2026/Insulet-Reveals-New-Data-Supporting-Breakthrough-Omnipod-6-and-Fully-Closed-Loop-AID-Systems-Designed-to-Improve-Outcomes-Reduce-Effort-and-Unlock-Barriers-to-Care/default.aspx
- https://investor.insulet.com/news/news-details/2025/Insulet-Outlines-Long-Term-Strategy-to-Drive-Growth-and-Value-Creation-at-2025-Investor-Day/default.aspx