MILLENNIALS
Research type
Research Study
Full title
An open-label, single-centre, randomised, cross-over design feasibility study to assess the efficacy of real-time continuous glucose monitoring in comparison with self-monitoring of blood glucose in young adults and adolescents with type 1 diabetes
IRAS ID
240575
Contact name
Hood Thabit
Contact email
Sponsor organisation
Manchester University NHS Foundation Trust
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
People with type 1 diabetes need to regularly monitor their glucose levels to ensure that their insulin therapy is given effectively and safely. It is important to keep glucose levels in the normal range, as this is known to prevent long-term complications of diabetes involving the eyes, kidney and heart. Achieving normal glucose levels however can be very challenging, specifically in the adolescent and young adults with type 1 diabetes. The number of blood glucose testing per day is low in the young adult population (18-25 years).Those with the lowest testing frequency have been reported to have the poorest diabetes control. Amongst the possible underlying reason is the inconvenience of performing frequent blood glucose testing. A novel approach to reduce the burden of glucose monitoring and support self-management is therefore needed in this group.
One solution is to use a continuous glucose monitor (CGM) sensor which provides glucose levels and trends on continuous basis without the need for frequent finger-prick blood testing. CGM can also alerts the person of high or low glucose levels, to allow changes to be made to their insulin doses or treatment.The DEXCOM G5 CGM system which will be used in the study, uses a mobile phone app to reduce the number of device burden, and allows remote connectivity and automatic upload of glucose data to support their diabetes management.
We now plan to carry out a study to test the Dexcom G5 (or similar) system in young adults (age 16-24 years old) with Type 1 diabetes to assess the efficacy of CGM compared to self monitoring of blood glucose (SMBG). The study will involve two sessions, each session lasting for 2 months. During the first session, participants will use CGM to monitor their glucose levels. In the second session, participants will monitor their glucose levels through SMBG.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
18/NW/0183
Date of REC Opinion
23 Apr 2018
REC opinion
Favourable Opinion