CREATE (Community deRivEd AutomaTEd insulin delivery) trial. Randomised parallel arm open label clinical trial comparing automated insulin delivery using a mobile controller (AnyDANA-loop) with an open-source algorithm with sensor augmented pump therapy in type 1 diabetes

BACKGROUND: Commercialised automated insulin delivery (AID) systems have demonstrated improved outcomes in type 1 diabetes (T1D), however, they have limited capacity for algorithm individualisation, and can be prohibitively expensive if an individual is without access to health insurance or health funding subsidy. Freely available open-source algorithms, which have the ability to individualise algorithm parameters paired with commercial insulin pumps, and continuous glucose monitoring make up the so-called "do it yourself" (DIY) approach to AID. Limited data on the open-source approach have shown promising results, but data from a large randomised control trial are lacking. METHODS: The CREATE (Community deRivEd AutomaTEd insulin delivery) trial is an open-labelled, randomised, parallel 24-week, multi-site trial comparing sensor augmented pump therapy (SAPT) to our AnyDANA-loop. The three components of AnyDANA-loop are: 1) OpenAPS algorithm implemented in a smartphone (a version of AndroidAPS), 2) DANA-i™ insulin pump and, 3) Dexcom G6(R) continuous glucose monitor (CGM). The primary outcome measure is the percentage of time in target sensor glucose range (3.9 -10mmol/L). Secondary outcomes include psycho-social factors and platform performance. Analysis of online collective learning, characteristic of the open-source approach, is planned. 100 participants with T1D aged 7 – 70 years (age stratified into children/adolescents 7–15 years and adults 16–70 years), will be recruited from four sites in New Zealand. A 24-week continuation phase follows, to assess long-term safety.