Glycemic Outcomes During Outpatient Use of Automated Insulin Delivery Without Meal Announcement in Adults with Type 1 Diabetes: Results from the CLOSE IT Randomized Controlled Trial.
Tom Wilkinson, Natalie Nanayakkara, David Burren et al.
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In 30 seconds
The CLOSE IT randomized, open-label, parallel-arm trial compared an open-source automated insulin delivery (AID) system used without meal announcement with the same system used as hybrid closed-loop (HCL) in adults aged 18–70 years with type 1 diabetes. After a 12-week run-in using meal announcement, 73 participants were assigned to either approach for 12 weeks. At trial end, adjusted time in the 70–180 mg/dL target range was similar: the difference for AID without meal announcement versus HCL was -2.2 percentage points (95% confidence interval: -6.2 to 1.7).
Key findings
- Among 36 participants assigned to AID without meal announcement, time in range was 66 ± 8% at trial end, compared with 69 ± 13% among 37 assigned to HCL.
- The adjusted between-group difference in time in the 70–180 mg/dL target range was -2.2 percentage points (95% confidence interval: -6.2 to 1.7).
Why it matters
Meal announcement is a recommended manual step in current AID systems. This trial provides comparative evidence that, in adults with type 1 diabetes using this open-source system, omitting that step produced similar time in range over the 12-week trial. The result informs evaluation of less user-dependent AID approaches, while applying specifically to the system and study conditions tested.
What to keep in mind
The trial was open-label and evaluated one open-source AID system over a 12-week trial phase.