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
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.
Summary of Results
People with type 1 diabetes need insulin to keep their blood glucose levels within a healthy range. Many people use insulin pumps, and newer "closed-loop" systems can automatically adjust insulin delivery based on continuous glucose monitor readings. However, these systems still work best when people remember to give themselves insulin before eating. Missing a mealtime insulin dose can lead to high blood glucose levels.
This study aims to find out whether a newer, faster-acting insulin called Lyumjev can improve blood glucose control compared with standard insulin lispro when used in a fully automated closed-loop system, particularly in a situation where a lunchtime insulin dose is missed. Lyumjev is absorbed more quickly after it is delivered under the skin, allowing it to start lowering blood glucose sooner than standard insulin.
The study will involve up to 26 adults with type 1 diabetes who use an insulin pump. Each participant will attend two 12-hour visits at the clinical research facility. During one visit, the closed-loop system will use Lyumjev, and during the other it will use standard insulin lispro. The order will be decided at random.
On both study days, participants will eat the same meals. The closed-loop system will automatically adjust insulin delivery throughout the day based on continuous glucose monitor readings. To mimic a missed mealtime insulin dose, participants will not receive their usual insulin bolus before lunch.
Researchers will compare how well the two insulins keep blood glucose levels within the target range during the afternoon. They will also assess how much time participants spend with blood glucose levels that are too high or too low, along with other measures of glucose control. The study will also monitor the number of episodes of hypoglycaemia (low blood glucose) and hyperglycaemia (high blood glucose) to assess the safety of each insulin.
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