Closed-loop with faster-acting insulin aspart and insulin aspart
Research type
Research Study
Full title
An open-label, single-centre, randomised, two-period, cross-over study to assess the efficacy and safety of day and night automated closed-loop glucose control for 24 hours in adults with type 1 diabetes comparing faster-acting insulin aspart with insulin aspart.
IRAS ID
249216
Contact name
Lalantha Leelarathna
Contact email
Sponsor organisation
Manchester University NHS Foundation Trust
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
U1111-1207-0053, The Universal Trial Number (UTN)
Duration of Study in the UK
0 years, 6 months, 31 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.
Keeping 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.
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 have shown that closed loop glucose control is superior to usual insulin pump therapy.
Faster-acting insulin aspart (Fiasp) is a novel formulation of insulin aspart resulting in accelerated initial absorption and more than double the glucose lowering effect in the first 30 minutes with insulin pumps.
To date, no closed-loop study has been performed to evaluate the benefit of faster-acting aspart over insulin aspart using Cambridge closed-loop system.
The main objective of the study is to determine whether closed-loop using novel faster-acting insulin aspart will improve glucose control and reduce the burden of hypoglycaemia over a 23-hour period compared to insulin aspart under conditions mimicking under-estimation of meal carbohydrate content or missed meal bolus.
This is an open-label, single-centre, two-period, randomised, cross over study. Up to 22 adults with type 1 diabetes and treated with an insulin pump will be recruited, aiming for 16 completed participants. Recruitment will take place at Manchester Diabetes Centre, Manchester Royal Infirmary, Manchester, UK.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
19/NW/0681
Date of REC Opinion
21 Nov 2019
REC opinion
Favourable Opinion