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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Danielle
McDermott
danielle.mcdermott@mft.nhs.uk
Dr
Hood
Thabit
hood.thabit@mft.nhs.uk
Diabetes mellitus
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
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.
Ultra-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.
To 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.
The 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.
This 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.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Interventional type: Drug;
You can take part if:
You may not be able to take part if:
1) Non-type 1 diabetes mellitus including those secondary to chronic disease. 2) Any other physical or psychological disease likely to interfere with the normal conduct of the study. 3) Untreated celiac disease or hypothyroidism. 4.Clinically significant nephropathy, neuropathy or proliferative retinopathy as judged by the investigator 5) Total daily insulin dose > 2 U/kg/day. 6) Total daily insulin dose < 10 U/day. 7) Pregnancy, or planned pregnancy or breast feeding.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by MANCHESTER UNIVERSITY NHS FOUNDATION TRUST and funded by DIABETES CARE TRUST (ABCD) LIMITED .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Read full details
for Trial ID: CPMS 55886
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