Fully automated insulin (Lyumjev) + pramlintide closed loop without carb counting
What this study tests
A crossover trial with 26 completers (ADA 2026 conference abstract) compared fully automated Lyumjev plus pramlintide without carbohydrate counting against a hybrid Lyumjev-plus-placebo loop. Time in range was numerically similar, but neither pramlintide comparison met the prespecified 5-percentage-point noninferiority margin.
Editorial review: .
Registry checked: 2026-09-17. Registry’s own update: 2024-04-18.
Most recent recorded citation date: 2026-06-07. Only explicit date metadata is included; an undated citation may be newer. This does not mean every claim was reviewed on that date.
Trial status, labels and access can change between reviews. How we review the evidence · How to read the evidence
Evidence at a glance
- Who can enter the study?
- Adults 18 and over with type 1 diabetes for at least 12 months, on insulin pump therapy for at least 3 months. Excludes gastroparesis, drugs that alter gut motility, recent GLP-1 or SGLT2 inhibitor use, and pregnancy. Registered eligibility ↗Enrollment criteria describe who may enter. They do not establish who was analyzed or the denominator for a reported result.
- Reported benefit and results
- The published ADA abstract reports 26 completers: time in range was 71.1% and 71.2% with the two pramlintide ratios versus 72.1% with hybrid control. Noninferiority was not established (P=0.0787 and 0.0584; margin 5 percentage points). Gastrointestinal events occurred in 7 and 8 participants during the respective pramlintide periods. No severe hypoglycemia or DKA occurred. This is a conference abstract, not a full trial report.Read the result sources and their limitations →
- Important harms
- Read the reported results, safety discussion and original sources. A separate harms summary is not available; this does not establish safety.
- Research access and approval
- Study regions: Canada. A trial listing does not establish product approval or current recruitment at a particular site. Check the study’s current entry requirements.
- What remains uncertain?
- Read the full discussion and original sources for study limitations. Planned endpoints and completion dates are not results.
Research status alone does not establish approval, clinical benefit or local availability. This record cites company or conference reports. Those sources may describe interim findings; their source type is shown in the source list.
Registry status: Recruitment status unconfirmed. The displayed trial status also reflects the cited study evidence.
Primary endpoints
- Percentage of time with glucose in range 70-180 mg/dL (3.9-10.0 mmol/L) over 18 days within each 3-week intervention (registry analysis window)
The full picture
What was tested
Each participant used three 21-day regimens in random order: a hybrid automated Lyumjev-plus-placebo loop with carbohydrate-matched boluses, or fully automated Lyumjev plus pramlintide at 8 or 10 µg per unit with no meal announcement. The registry's primary outcome was percentage of time in 70–180 mg/dL (3.9–10.0 mmol/L) over 18 days. Study protocol and eligibility.
What the primary abstract supports
The ADA abstract reports 26 completers with similar average time in range across regimens, but the study did not establish noninferiority within its five-percentage-point margin. The abstract reports lower insulin requirements alongside gastrointestinal adverse events, and no severe hypoglycemia or DKA. A small conference-abstract study cannot establish long-term safety or identify who will benefit.
Earlier text relied on a secondary conference write-up. The published ADA abstract is now the outcome source; subgroup and additional hypoglycemia figures that were not corroborated there have been removed. A complete peer-reviewed trial report was not identified during this review.
Registry and current context
The registry lists overall status UNKNOWN (last known RECRUITING), last updated 18 April 2024, despite the completed crossover study reported in the abstract. We show both dates and use completed for the reported study. Fully automated approaches now also include CamAPS Liberty, described in the linked record as launched in selected European markets in September 2026; meal announcement is no longer required by every marketed system.
Sources
- [1]1260-OR: Fully Closed-Loop Delivery of Ultra-Rapid Insulin Lispro and Pramlintide vs. Carbohydrate Counting in Type 1 Diabetes · Conference finding · 2026-06-07
- [2]NCT06046417: study record · Trial registry — Current status, study design and eligibility checked 16 September 2026; this does not imply posted outcomes.