Dexcom Hybrid Closed Loop Insulin Pump Study in Type 1 Diabetes
Research type
Research Study
Full title
An evaluation of the Tandem T:Slim insulin pump and DEXCOM G6 continuous glucose monitoring hybrid closed loop insulin delivery system (control-IQ) on patient wellbeing and diabetes control in adults with Type 1 diabetes
IRAS ID
299847
Contact name
John McKnight
Contact email
Sponsor organisation
University of Edinburgh
Duration of Study in the UK
1 years, 8 months, 20 days
Research summary
Treatment of Type 1 diabetes requires daily insulin therapy given by either multiple daily injections or by continuous infusion via a pump. The insulin dose is calculated taking into consideration blood glucose levels, food intake and activity levels, aiming to avoid high and low readings.
The Tandem t:slim X2™ insulin pump has recently become available in NHS Scotland and can link with the Dexcom G6 continuous glucose monitoring (CGM) system. The Tandem Control IQ hybrid closed loop system is made up of the Tandem insulin pump communicating wirelessly with the Dexcom G6 CGM. The algorithm within the pump then automatically controls the background (basal) insulin infusion rate. Manually delivered bolus insulin is still required for meals. This system is designed to finely tune insulin delivery and increase the amount of time that glucose is in the target range, reducing hypoglycaemia and hyperglycaemia.Insulin pumps are funded by NHS Scotland, but the Dexcom G6 continuous glucose monitoring system is not, so this hybrid closed loop system is not currently routinely available in NHS Scotland. The purpose of this study is to gain experience of this system and investigate how effective and acceptable the hybrid closed loop system is for people in Scotland. Participants will be provided with the Dexcom G6 CGM device to link to their current pump to create the hybrid closed loop system for the duration of the study.\n30 people with Type 1 diabetes who have been using the Tandem pump for at least one month will be invited to participate.
The study will include a screening visit, a 30 day run-in period, 52 week treatment period and 12 week follow-up period. Diabetes control will be measured using HbA1c and downloaded information from the hybrid closed loop system. Participants will also complete questionnaires and a reflective diary.
REC name
North of Scotland Research Ethics Committee 1
REC reference
21/NS/0134
Date of REC Opinion
29 Oct 2021
REC opinion
Favourable Opinion