Day and night closed-loop in young people with type 1 diabetes (DAN05)
Research type
Research Study
Full title
An open-label, multi-centre, randomised, single-period, parallel study to assess the efficacy, safety and utility of 12 month day-and-night automated closed-loop insulin delivery under free living conditions compared to insulin pump therapy in children and adolescents with type 1 diabetes
IRAS ID
211295
Contact name
Roman Hovorka
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust and University of Cambridge
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Closed-loop technology combines continuous glucose monitoring (CGM) and insulin pump using a control algorithm that automatically directs insulin delivery in response to real-time CGM levels. The closed-loop approach has been successfully evaluated in young people with type 1 diabetes (T1D) in controlled laboratory studies and in home settings. Performance and benefits of closed-loop systems in children and adolescents over a prolonged period is yet to be determined.
This is an open-label, multi-centre, multi-national, single-period, randomised, parallel group design study, involving a 12 month period of home study during which day and night glucose levels will be controlled either by a closed-loop system (intervention group) or by insulin pump therapy alone (control group).
The main study objective is to determine whether 24/7 automated closed-loop application will improve glucose control as measured by HbA1c. We will also assess cognitive, emotional, and behavioural characteristics of participants and family members and their response to closed-loop.
It is expected that a total of up to 150 subjects (aiming for 130 randomised subjects) with T1D (6-18 years) will be recruited through diabetes clinics of the investigation centres. Participants will all be on insulin pump therapy.
Subjects in the intervention group will receive appropriate training in the safe use of closed-loop system prior to home use. All subjects will have regular contact with the study team during the home study phase including 24/7 telephone support. The primary outcome is between group differences in HbA1c levels at 12 months. Secondary outcomes are the time spent in glucose target (3.9 to 10.0mmol/l), time spent with glucose levels above and below target based on CGM. Safety evaluation comprises assessment of the frequency of severe hypoglycaemic episodes and diabetic ketoacidosis. Cognitive, emotional, and behavioural characteristics of participating subjects and family members will be assessed using validated surveys and focus groups discussions.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
16/EE/0380
Date of REC Opinion
28 Nov 2016
REC opinion
Further Information Favourable Opinion