The Bio-inspired Artificial Pancreas for the Home
Research type
Research Study
Full title
The Bio-inspired Artificial Pancreas for the Home
IRAS ID
215990
Contact name
Nick Oliver
Contact email
Sponsor organisation
Imperial College London
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Summary of Research
A closed-loop insulin delivery system, also known as an artificial pancreas, provides the potential to improve glucose control while avoiding hypoglycaemia in people with type 1 diabetes. It requires continuous glucose measurement by a subcutaneous continuous glucose sensor, a control algorithm and a pump for insulin delivery. To support mealtime insulin dosing, people with type 1 diabetes use bolus calculators to provide insulin dose recommendations.The diabetes technology group at Imperial College have developed a bio-inspired artificial pancreas (BiAP) system which uses a control algorithm based on how the pancreas produces insulin and an Advanced Bolus Calculator for Diabetes (ABC4D), a novel, adaptive decision support algorithm based on case-based reasoning (CBR), an artificial intelligence technique providing real-time insulin advice through a smartphone application.
The main objectives of this research study is to evaluate the safety, efficacy and cost-effectiveness of the bio-inspired artificial pancreas with, and without, the addition of an ABC4D adaptive bolus calculator compared to gold-standard sensor-augmented pump therapy in a randomised controlled trial. The primary outcome from the studies will be % time spent with a glucose concentration in the target glucose range (3.9-10.0mmol/l). Other outcome measures include percentage time spent in hypoglycaemia (low glucose), hyperglycaemia (high glucose), quality of life, treatment satisfaction and acceptability of the technology.
The complete device used in this study comprises a commercial continuous subcutaneous glucose sensor (Dexcom G5 CGM system), the BiAP control algorithm implemented in a low-power handheld device, the ABC4D adaptive bolus calculator algorithm in a smartphone platform.
Summary of Results
This study was terminated early. Eight participants were recruited of which two participants were randomised to the intervention group and commenced the use of the closed-loop system. During the first two weeks, the participants reported multiple disconnections between the components of the closed-loop system leading to loss of communication between components. The study was halted to allow the technical issues to be fixed. Preliminary clinical data showed that the the two participants spent 70% and 77%, respectively, of their time within the glucose target of 3.9-10mmol/l over the two week time period.There were no reported adverse events or serious adverse events during the study.REC name
London - Stanmore Research Ethics Committee
REC reference
17/LO/0457
Date of REC Opinion
30 May 2017
REC opinion
Further Information Favourable Opinion