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

Abstract

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 24week, 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.

Full closed loop open‐source algorithm performance comparison in pigs with diabetes

“…9 Open-source algorithms for closed loop or automated insulin delivery (AID) predate commercial availability of such systems and have been developed by members of the diabetes community. [10][11][12][13] The three most common systems include OpenAPS, Loop, and AndroidAPS. 14,15 Each has an emphasis on safety but are unregulated, as they are user-designed and user-driven.…”

“…10,17,18 Work is just beginning on randomized controlled trials analyzing these systems in hybrid closed loop mode (where users are typically announcing meals); there are currently no head-to-head studies comparing automated insulin delivery system performance without meal announcement. 13 In developing these algorithms further for use without meal announcements, it is important to understand the performance of each in clinical practice. In this study, we evaluate the algorithms used in OpenAPS/AndroidAPS and Loop, without meal announcements or user interactions, in a pig model of insulin-deficient diabetes.…”

Pre‐school and school‐aged children benefit from the switch from a sensor‐augmented pump to an AndroidAPS hybrid closed loop: A retrospective analysis

“…He showed a significant reduction of HbA1c, better fasting blood glucose and less hypo or hyperglycemia during the daytime before the meals and after the boluses and reduction of totally daily insulin dose in adults patients using AndroidAPS 39 . Another open‐labeled randomized control study comparing SAP and AndroidAPS DANA pump (the CREATE trial) is running in New Zealand 40 …”

“…39 Another open-labeled randomized control study comparing SAP and AndroidAPS DANA pump (the CREATE trial) is running in New Zealand. 40 The prospective RCT should be finished to eliminate safety concern with DIY closed loop systems. Our participants did not report any episodes of diabetic ketoacidosis or severe hypoglycemia during the whole 346 patient-month period of AndroidAPS.…”

How It Started, How It Is Going: The Future of Artificial Pancreas Systems (Automated Insulin Delivery Systems)

“…10 They have been studied not only in retrospective and observational studies 11,12 but also in silico 13 as well as ongoing, randomized control trials. 14…”