Safety and Feasibility of a Fully Automated Insulin Delivery System: Fully Closed-loop (FCL)@Home, a Multicenter Randomized Clinical Trial in Individuals With Type 1 Diabetes
Authors' conclusion
FCL therapy with the AIDANET system can significantly improve average glycemic control while removing the need for mealtime bolusing for a broad population of people with T1D.
Study context
- Population
- Adults (>25 years), young adults (18–25 years) and adolescents (14–18 years) with T1D, 3 US sites; mean age 25.4 ± 12.6 years, 62% female, mean HbA1c 8.0 ± 1.1%, 94% hybrid closed loop users during usual care (UC)completed the study
- Participants
- 34 adults
- Comparison
- AIDANET system in fully closed-loop (FCL) without meal announcements vs usual care (UC)
- Primary endpoint
- Change in mean sensor glucose (MSG) between the 2nd week of UC and the week of the FCL at-home period
Methodological detailscrossover, multicentre
- Crossover
- Multicentre
Primary result
As reported in the abstract
Mean sensor glucose
P = 0.0058
Further findings
TIR (70-180 mg/dL), time in tight range (70-140 mg/dL), TAR (>180 and >250 mg/dL)
- Significantly improved with FCL vs UC, primarily overnight
Safety
Time <70 and <54 mg/dL
- Significantly noninferior in FCL compared with UC
Original publication
Safety and Feasibility of a Fully Automated Insulin Delivery System: FCL@Home, a Multicenter Randomized Clinical Trial in Individuals With Type 1 Diabetes. Diabetes Care. Published 16 December 2025. doi:10.
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