Impact of hybrid closed loop systems in people with type I diabetes
Research type
Research Study
Full title
Mixed methods study exploring the impact of hybrid closed-loop systems on patient reported outcomes in people with type I diabetes and their partners
IRAS ID
304091
Contact name
Pratik Choudhary
Contact email
Sponsor organisation
University of Leicester
Duration of Study in the UK
1 years, 4 months, 1 days
Research summary
Type 1 diabetes requires patients to constantly monitor their blood glucose and adjust insulin doses to try and keep glucose levels in range. Hybrid closed loop systems (also called artificial pancreas) consist of a sensor that continuously measures glucose levels, an algorithm that then decides every few minutes how much insulin to deliver and an insulin pump that then delivers the insulin. These systems have been shown in observational and randomized studies to improve glucose levels and have high levels of satisfaction.
The NHS has launched a pilot for up to 1000 people with type 1 diabetes to trial these devices for up to 1 year and the results of that pilot will be audited by clinical teams. This study will recruit people from that pilot and use well validated questionnaires to assess the impact of this technology on various key patient reported outcomes such as depression, diabetes related distress and fear of hypoglycemia (low blood glucose). We will invite a small number of participants to take part in semi-structured interviews to gain a more detailed understanding of the benefits and challenges of using these devices, and the impact they have on people living with type 1 diabetes. We know that living with a partner with type 1 diabetes can also have a negative impact on quality of life, and so we will also invite partners of people using the hybrid closed loops systems to complete some of the questionnaires and invite a small sample of those for interviews as well.
We hope that the data from this real-world study of the impact of hybrid closed loop systems on patient reported outcomes will be of value to clinicians, people with type 1 diabetes and policy makers in understanding the value of these systems.
REC name
West Midlands - Black Country Research Ethics Committee
REC reference
21/WM/0245
Date of REC Opinion
1 Nov 2021
REC opinion
Favourable Opinion