First use of Open-Source Automated Insulin Delivery AndroidAPS in Full Closed Loop scenario; Pancreas4ALL randomized pilot study
Abstract
OBJECTIVE We evaluated the safety and feasibility of open-source automated insulin delivery AndroidAPS, in adolescents and young adults with type 1 diabetes (T1D) and compared its efficacy in three different scenarios: Hybrid Closed Loop with premeal boluses (HCL), Meal Announcement only (MA) and Full Closed Loop (FCL). RESEARCH DESIGN AND METHODS In an open-label, prospective, randomized crossover trial (clinicaltrials.gov NCT04835350), 16 adolescents with T1D (10 females) with mean age 17 years (range 15-20), HbA1c 56 mmol/mol (range 43-75) and mean duration of diabetes 5.9 years (9-15), underwent three distinct 3-day periods of camp living, comparing the above-mentioned scenarios of AndroidAPS.
We used modified and locked version of AndroidAPS 3.1.03 which was called Pancreas4ALL for study purpose. The order of MA and FCL periods was assigned randomly.
The primary endpoints were feasibility and safety of the system represented by percentage of time of glucose control by the system and time in hypoglycemia below 3 mmol/L. RESULTS The glycemia was controlled by the system 95% time of the study and the proportion of time below 3 mmol/L did not exceed 1% over the whole study period (0.72%).
The HCL scenario reached significantly higher percentage of time below 3 mmol/L (HCL 1.05% vs MA 0.0% vs FCL 0.0%; p=0.05) compared to other scenarios. No differences were observed among the scenarios in the percentage of time between 3.9-10 mmol/L (HCL 83.3% vs MA 79.85% vs FCL 81.03%, p=0.58) corresponding to mean glycemia (HCL 6.65mmol/L vs MA 7.34mmol/L vs FCL-7.05mmol/L, p=0.28).
No differences were observed in the mean daily dose of insulin nor in the daily carbohydrate intake. No serious adverse events occurred during the study period.
CONCLUSIONS Our pilot study showed that Fully Closed Loop might be a realistic mode of treatment for people with type 1 diabetes.