BELIEVE
Research type
Research Study
Full title
Feasibility of Automated Insulin Delivery with an Interoperable Algorithm Using an Alternative Insulin Pump
IRAS ID
281686
Contact name
Nick Oliver
Contact email
Sponsor organisation
Imperial College
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
The inControl algorithm, currently embedded in the Tandem X2 insulin pump, operates with the Dexcom G6 to create a hybrid closed-loop system (automated insulin delivery system) and is currently FDA approved. It has been shown to improve time in range when compared to sensor augmented pump therapy (using the Dexcom G6 glucose monitoring to guide insulin pump decisions). This study aims to look at whether the algorithm can work with multiple insulin delivery devices, specifically in the YpsoPump insulin pump using an android handset.
The new components of the automated insulin delivery system are the algorithm and the insulin pump. The Dexcom G6 continuous glucose monitoring device is CE marked and is licensed to be used to inform insulin dosing decisions without confirmation. The algorithm (InControl) is FDA approved in the United States when used embedded in the Tandem insulin pump. We are using the algorithm for its intended purpose but are implementing it in a smartphone app. We are additionally assessing incremental benefit with the next software version of the algorithm. This will be the first time this updated software has been assessed in people with type 1 diabetes. The insulin pump is a continuous subcutaneous insulin infusion device and is being used in line with its intended purpose, according to the manufacturer’s instructions.
REC name
East of England - Essex Research Ethics Committee
REC reference
21/EE/0220
Date of REC Opinion
17 Nov 2021
REC opinion
Further Information Favourable Opinion