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Be Part of Research - Trial Details - Closing the Loop in Adults With Type 1 Diabetes and HbA1C<7.5% Under Free Living Conditions
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Closing the Loop in Adults With Type 1 Diabetes and HbA1C<7.5% Under Free Living Conditions

Completed

Open to: ALL

Age: 18.0 - N/A

Cambridge

Medical Conditions

Diabetes Mellitus
Diabetes Mellitus, Type 1

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.


The main objective of this study is to determine whether day and night closed-loop insulin delivery for 4 weeks under free living conditions is superior to usual insulin pump therapy in adults with type 1 diabetes and HbA1C\<7.5%.

This is an open-label, multi center, randomized, crossover design study, involving a 2-4 week run-in period, followed by two 4 weeks study periods during which glucose levels will be controlled either by an automated day- and night closed-loop system or by subjects usual insulin pump therapy in random order. A total of up to 34 adults (aiming for 24 completed subjects) aged 18 years and older with T1D on insulin pump therapy and HbA1C\<7.5% will be recruited through diabetes clinics and other established methods in participating centers.

Subjects will receive appropriate training in the safe use of closed-loop insulin delivery system. Subjects will have regular contact with the study team during the home study phase including 24/7 telephone support.

The primary outcome is time spent in target range between 3.9 and 10.0 mmol/L as recorded by CGM during home stay. Secondary outcomes are time spent with glucose levels above and below target, as recorded by CGM, and other CGM-based metrics.

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:

Mar 2016 Oct 2016

Publications

"Bally L, Thabit H, Kojzar H, Mader JK, Qerimi-Hyseni J, Hartnell S, Tauschmann M, Allen JM, Wilinska ME, Pieber TR, Evans ML, Hovorka R. Day-and-night glycaemic control with closed-loop insulin delivery versus conventional insulin pump therapy in free-living adults with well controlled type 1 diabetes: an open-label, randomised, crossover study. Lancet Diabetes Endocrinol. 2017 Apr;5(4):261-270. doi: 10.1016/S2213-8587(17)30001-3. Epub 2017 Jan 14."; "28094136"

INTERVENTIONAL

Intervention Type : DEVICE
Intervention Description : Subject's glucose level will be controlled by the Florence D2A or similar automated closed loop glucose control system. The system comprises of FreeStyle Navigator 2 ® Continuous Glucose Monitoring (CGM) System (Abbott Diabetes Care, Alameda, CA, USA), Dana R Diabecare subcutaneous insulin infusion pump (Sooil Corp. Seoul, South Korea)or similar insulin pump, and MPC-based glucose control algorithm running on a smartphone

Intervention Arm Group : day and night closed loop control;

Intervention Type : DEVICE
Intervention Description : Subject glucose level controlled by usual insulin pump therapy in conjunction with continuous glucose monitoring (CGM)

Intervention Arm Group : usual insulin pump therapy management;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Cambridge University Hospitals NHS Foundation Trust, Addenbrookes Hospital
    Cambridge
    Cambridgeshire
    CB2 0QQ


The study is sponsored by University of Cambridge and is in collaboration with Medical University of Graz.




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Read full details for Trial ID: NCT02727231
Last updated 09 October 2016

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