16 September 2026 editorial review · Trial
Fully automated insulin (Lyumjev) + pramlintide closed loop without carb counting: 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: Located publisher-deposited primary ADA abstract 1260-OR (DOI10.2337/db26-1260-or) through Crossref. Verified26 completers,5 percentage point noninferiority margin, failure of both comparisons, gastrointestinal events and no severe hypoglycemia/DKA. Removed secondary-report-only subgroup claims and replaced obsolete universal meal-announcement claim.
Registry: NCT06046417; UNKNOWN; updated 2024-04-18; enrollment 30 (ESTIMATED); results not posted.
Endpoint comparison: Percentage of time of glucose levels spent in the target range (3.9-10.0 mmol/L). (18 days).
Sources for this record: 1260-OR: Fully Closed-Loop Delivery of Ultra-Rapid Insulin Lispro and Pramlintide vs. Carbohydrate Counting in Type 1 Diabetes (conference); NCT06046417: study record (registry).
Limits: No full peer-reviewed outcome report was identified for the current study; a conference abstract cannot resolve unreported participant-level safety or attrition.