First Use of Open-Source Automated Insulin Delivery AndroidAPS in Full Closed-Loop Scenario: Pancreas4ALL Randomized Pilot Study
Authors' conclusion
Our pilot study showed that FCL might be a realistic mode of treatment for people with T1D.
Study context
- Population
- Adolescents with T1D (10 females), mean age 17 years (range 15–20), HbA1c 56 mmol/mol (range 43–75), mean diabetes duration 5.9 yearscrossover
- Participants
- 16 adolescents
- Comparison
- AndroidAPS hybrid closed loop (HCL) with meal boluses vs meal announcement only vs full closed loop
- Primary endpoint
- Feasibility and safety: percentage of time of glucose control by the system and time in hypoglycemia below 3 mmol/L
Methodological detailsopen-label, prospective, pilot, 3-day camp periods
- Open-label
- Prospective
- Pilot
- 3-day camp periods
Primary result
As reported in the abstract
Glycemia controlled by the system
95% time
Time below 3 mmol/L over whole study
0.72%
Further findings
Time below 3 mmol/L by scenario — HCL vs MA · across HCL, MA and FCL; significantly higher with HCL
P = 0.05
Time between 3.9 and 10 mmol/L — between HCL and MA · across HCL, MA and FCL; no difference
P = 0.58
Mean glycemia — between HCL and MA · across HCL, MA and FCL
P = 0.28
Mean daily insulin dose and daily carbohydrate intake
- No difference in mean daily insulin dose or daily carbohydrate intake
Safety
- No serious adverse event occurred
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
First Use of Open-Source Automated Insulin Delivery AndroidAPS in Full Closed-Loop Scenario: Pancreas4ALL Randomized Pilot Study. Diabetes Technol Ther. Published 24 February 2023. doi:10.
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