286-OR: The CREATE Trial: Randomized Clinical Trial Comparing Open-Source Automated Insulin Delivery with Sensor Augmented Pump Therapy in Type 1 Diabetes

Abstract

Objective: Open-source automated insulin delivery (AID) pre-dated the availability of commercial systems and is used by thousands of people with T1D despite no regulatory approval. Our objective was to examine efficacy and safety of open-source AID. Methods: A 24 week, multi-center RCT in children (7-15 years) and adults (16-70 years) with T1D comparing open-source AID (using the OpenAPS algorithm from a version of AndroidAPS implemented in a smartphone with the DANA-i™ insulin pump and Dexcom G6® CGM) , to sensor augmented pump therapy (SAPT) . The primary outcome was change in the percent of time in target sensor glucose range (TIR; 3.9-10mmol/L) from run-in to the last two weeks of the RCT. Results: Ninety-seven patients (48 children and 49 adults) were randomized. Glycemic data are shown in table 1. Mean TIR (±SD) at study end was 74.5±11.9% using AID (Δ+ 9.6±11.8% from run-in; P<0.001) for adults, and 67.5±11.5% (Δ+ 9.9±14.9% from run-in; P<0.001) for children. Mean TIR at study end for the SAPT arm was 56.5±14.2% and 52.5±17.5% for adults and children respectively, with no change from run-in. No severe hypoglycemic or DKA events occurred in either arm. Two participants withdrew from AID due to hardware issues. Conclusion: Open-source AID using the OpenAPS algorithm within a version of AndroidAPS, a widely used open-source AID solution, appears safe and effective. Disclosure M.J. Burnside: None. D.M. Lewis: None. H. Crocket: None. R. Meier: None. J. Williman: None. O.J. Sanders: None. C.A. Jefferies: None. A.M. Faherty: None. R. Paul: Advisory Panel; Eli Lilly and Company. Speaker's Bureau; Boehringer Ingelheim International GmbH, Eli Lilly and Company, Novo Nordisk. C.S. Lever: None. B.J. Wheeler: Research Support; Dexcom, Inc., i-SENS, Inc., Medtronic. T. Gunn: Other Relationship; Sooil Development Co. C. Lampey: None. M. de Bock: Research Support; Dexcom, Inc., Medtronic, Novo Nordisk, SOOIL, Ypsomed AG. Speaker's Bureau; Ypsomed AG. Funding Health Research Council of New Zealand (19/481 and 21/001)