Home testing of day and night closed loop with pump suspend feature
Research type
Research Study
Full title
An open-label, multi-centre, randomised, single-period, parallel design study to assess the efficacy, safety, utility and psychosocial effect of 12 week day and night automated closed-loop glucose control combined with pump suspend feature compared to sensor augmented insulin pump therapy in youth and adults with type 1 diabetes with sub-optimal glucose control under free living conditions
IRAS ID
182484
Contact name
Roman Hovorka
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust
Duration of Study in the UK
1 years, 0 months, 31 days
Research summary
The main study objective is to determine whether day and night automated closed-loop glucose control combined with pump suspend feature will improve glucose control as measured by HbA1c and reduce the burden of hypoglycaemia compared to sensor augmented insulin pump therapy alone.
This is an open-label, multi-centre, multi-national, single-period, randomised, parallel group design study, involving a three-month period of home study during which day and night glucose levels will be controlled either by a closed-loop system combined with pump suspend feature (intervention group) or by sensor augmented insulin pump therapy (control group).It is expected that up to 100 subjects, aiming for 84 randomised subjects [42 youth (6 to 21 years), and 42 adults (22 years and older)], with type 1 diabetes will be recruited through paediatric and adult outpatient diabetes clinics in each of the investigation centres. Subjects who drop out within the first four weeks of the intervention may be replaced. Participants will all be on subcutaneous insulin pump therapy and will have proven competencies both in the use of the study insulin pump and the study continuous glucose monitor (CGM) device.
Subjects in the intervention group will receive appropriate training in the safe use of closed-loop insulin delivery system and pump suspend feature. 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 the end of treatment period. Secondary outcomes are the time spent in the glucose target (3.9 to 10.0mmol/l), time spent with glucose levels above and below target, as recorded by CGM, and other CGM-based metrics. Safety evaluation comprises assessment of the frequency of severe hypoglycaemic episodes.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
15/EE/0324
Date of REC Opinion
13 Nov 2015
REC opinion
Further Information Favourable Opinion