Automated closed loop in children and adolescents with type 1 diabetes
Research type
Research Study
Full title
An open-label, single-centre, randomised, 2-period cross-over study to assess the efficacy and safety of a novel automated overnight closed-loop glucose control system on day 1 of continuous glucose monitoring sensor insertion in comparison to day 3 to 4 after sensor insertion in children and adolescents with type 1 diabetes
IRAS ID
131708
Contact name
Roman Hovorka
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust and University of Cambridge
Research summary
People with type 1 diabetes need regular insulin injections or continuous delivery of insulin using a pump. Keeping blood sugars in the normal range is known to reduce long term complications. However, achieving treatment goals can be very difficult due to the risk of low glucose levels (hypoglycaemia). One solution is to use a system where the amount of insulin injected closely matches the blood sugar levels on a continuous basis. This can be achieved by what is known as a “closed loop system“ where a small glucose sensor placed under the skin communicates with a computer containing an algorithm that drives a subcutaneous insulin pump. Previous studies conducted under carefully controlled clinical research facility environment, in Cambridge, UK as well as several other centres have shown that closed-loop glucose control is superior to usual insulin pump therapy. The next logical step in the development pathway is to test closed loop systems in the home environment. An essential requirement for conducting closed-loop studies outside clinical research facility is an automated system where wireless data transmission takes place between the glucose sensor and insulin pump. \n\nThe purpose of the present study is to evaluate the efficacy and safety of automated overnight closed-loop, in children and adolescents with type 1 diabetes, using a novel system which has greatest potential for use in the home setting. The study will take place at a clinical research facility on two occasions, using a standardised protocol. The performance of the closed-loop system will be evaluated on day 1 of CGM sensor life as compared to on days 3 to 4 of sensor life. Data and experience gained from this study will be used for further refinements and development of the system for future home use. \n
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
13/WM/0498
Date of REC Opinion
20 Jan 2014
REC opinion
Further Information Favourable Opinion