Home testing of 24/7 closed-loop in young people with type 1 diabetes
Research type
Research Study
Full title
An open-label, single-centre, randomised, two-period crossover study to assess the efficacy, safety and utility of day-and-night automated closed-loop glucose control over 7 days in comparison with continuous subcutaneous insulin infusion combined with continuous glucose monitoring alone in the home setting in children and adolescents with type 1 diabetes
IRAS ID
131482
Contact name
Roman Hovorka
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust and University of Cambridge
Clinicaltrials.gov Identifier
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 particularly 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 a 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. This current study aims to assess the feasibility, efficacy and safety of day and night closed-loop glucose control in the home setting over a short term period.
This study will involve two 7 day home study periods, during which glucose levels will be controlled either by an automated closed-loop system or by participants’ usual insulin pump therapy combined with continuous glucose monitoring alone in random order. Prior to the closed-loop study period, there will be a training period in the clinical research facility, which will allow participants to familiarise themselves with the closed-loop system before going home.
This study will aim for 12 completed participants aged 10 to 18 years with type 1 diabetes on insulin pump therapy. The data and experience gained from this study will be utilised in planning future longer and larger home studies.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
13/EE/0251
Date of REC Opinion
18 Oct 2013
REC opinion
Favourable Opinion