Closing the loop in adults with type 1 diabetes
Research type
Research Study
Full title
An open-label, multi-centre, randomised, two-period, crossover study to assess the efficacy, safety and utility of 12 week day and night automated closed-loop glucose control under free living conditions compared to conventional insulin pump therapy combined with continuous glucose monitoring in adults with type 1 diabetes with sub-optimal glucose control
IRAS ID
136248
Contact name
Roman Hovorka
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust
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 of closed-loop glucose control have shown that closed-loop glucose control is superior to usual insulin pump therapy.
The main objective of this study is to determine whether day and night closed-loop insulin delivery for 12 weeks under free living conditions is superior to addition of real-time continuous glucose monitoring (CGM) in adults with type 1 diabetes and sub-optimal glucose control on insulin pump therapy.
This is an open-label, multi centre, randomised, crossover design study, involving a 6 to 8 week run-in period, followed by two 3 months study periods during which glucose levels will be controlled either by an automated closed-loop system or by subjects’ usual insulin pump therapy augmented with real-time continuous glucose monitoring (CGM) in random order. A total of up to 42 adults (aiming for 30 completed subjects) aged 18 years and older with T1-D on insulin pump therapy will be recruited through diabetes clinics and other established methods in participating centres.
Subjects will receive appropriate training in the safe use of closed-loop insulin delivery system and will have regular contact with the study team during the home study phase including 24/7 telephone support.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
13/EE/0321
Date of REC Opinion
18 Oct 2013
REC opinion
Favourable Opinion