ACOLYTE
Research type
Research Study
Full title
An open-label, single-centre, randomised, two-period, cross-over study to assess the efficacy and safety of automated closed-loop glucose control in adults with type 1 diabetes comparing ultra-fast acting insulin lispro with insulin lispro.\t
IRAS ID
317222
Contact name
Hood Thabit
Contact email
Sponsor organisation
Manchester University NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
People with type 1 diabetes need regular insulin injections or continuous delivery of insulin using a pump. Estimation of carbohydrate quantity is an essential requirement for correct matching of insulin dosing with meals. However, both under and over-estimation of carbohydrate is common under real-life conditions.\n\nKeeping 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 and difficulties with estimating correct meal bolus.\n\nOne 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 have shown that closed loop glucose control is superior to usual insulin pump therapy.\n\nUltra-rapid insulin lispro (Lyumjev) is a novel formulation of insulin lispro resulting in accelerated initial absorption and more than double the glucose lowering effect in the first 30 minutes with insulin pumps.\n\nTo date, no closed-loop study has been performed to evaluate the benefit of ultra rapid insulin lispro over insulin lispro using Cambridge closed-loop system.\n\nThe main objective of the study is to determine whether closed-loop using novel ultra rapid insulin lispro will improve glucose control and reduce the burden of hypoglycaemia compared to insulin lispro under conditions mimicking missed meal bolus.\n\nThis is an open-label, single-centre, two-period, randomised, cross over study. Up to 26 adults with type 1 diabetes and treated with an insulin pump will be recruited, aiming for 19 completed participants. Recruitment will take place at Manchester Diabetes, Endocrinology and Metabolism Centre, Manchester Royal Infirmary, Manchester, UK.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
23/WM/0087
Date of REC Opinion
15 May 2023
REC opinion
Further Information Favourable Opinion