16 September 2026 editorial review · Trial
Bihormonal iLet Bionic Pancreas (insulin + glucagon) feasibility study: review notes
These notes document the scope actually reviewed, including source-access limits. They are not independent clinical certification or a guarantee that every claim was verified.
Read the trial evidence page →Primary-agent trial review — 16 September 2026
Assessment: Summary, current status, primary endpoint and key eligibility compared with the current registry. No additional discrepancy confirmed in that comparison. Historical outcome details beyond the primary sources explicitly discussed in the specialist ledgers were not all independently reverified.
Registry: NCT03840278; COMPLETED; updated 2019-12-16; enrollment 12 (ACTUAL); results posted.
Endpoint comparison: Percentage of Time That Valid CGM Glucose Readings Are Captured by the iLet Bionic Pancreas (Days 1-7); Percentage of Time That Each Drug Channel of the iLet Bionic Pancreas is Available (Days 1-7); The Ratio of Cumulative Drug Doses Delivered to Cumulative Drug Doses Attempted for Insulin and Dasiglucagon (Days 1-7).
Sources for this record: Performance of the Insulin-Only iLet Bionic Pancreas and the Bihormonal iLet Using Dasiglucagon in Adults With Type 1 Diabetes in a Home-Use Setting. (peer-reviewed); Castellanos LE, Balliro CA, Sherwood JS, et al. Diabetes Care (2021);44(6):e118-e120 (full text, PubMed Central PMC8247518) (peer-reviewed); The Bihormonal iLet Bionic Pancreas Feasibility Study. ClinicalTrials.gov, NCT03840278 (sponsor, collaborators, phase, design) (registry).
Limits: Source access and review depth vary. Registry fields establish the registered study, not clinical benefit, product approval or current local access. Cited-source reachability alone was not treated as verification of its claims.
Selected historical trial audit
Correction: Published report concerns ten participants completing two seven-day periods; registry lists twelve enrolled. Stated both without inventing reasons for the difference. Full Table 1 confirms engineering targets, descriptive glucose metrics, dasiglucagon dose and five insulin leaks. Removed Control-IQ relationship and qualified broad efficacy conclusions. Engineering feasibility and descriptive short-term glucose differences do not establish sustained clinical superiority.
Sources: Primary full report, registry.
Limit: Small, short open-label crossover; not powered to establish rare-event safety. Publication-versus-registry enrollment discrepancy remains source-specific.