Flash-glucose monitoring in sub-optimally controlled type 1 diabetes
Research type
Research Study
Full title
An open-label, multi-centre, randomised, parallel design study to assess the efficacy of flash glucose monitoring in adults with type 1 diabetes
IRAS ID
257593
Contact name
Lalantha Leelarathna
Contact email
Sponsor organisation
Manchester University NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 7 months, 0 days
Research summary
Research Summary
FreeStyle Libre (FSL) is a novel glucose monitoring device (Flash glucose monitoring) in the form of a disc worn on the arm for 14 days, and a hand-held reader which is designed to largely replace the recommended 4-10 painful finger-stick blood glucose tests required each day for the self-management of type 1 diabetes. The purpose of this study is to determine whether flash glucose monitoring with FSL device will improve HbA1c over 24 weeks compared to self-monitoring of blood glucose in adults and adolescents (16 or older) with sub-optimally controlled (HbA1c 7.5% to 11%) type 1 diabetes.This is an open-label, multi-centre, randomised, parallel design study, involving a 2-week run-in period, followed by a 24-week study period during which participants will be randomised to use either FSL or continue usual finger-stick glucose monitoring. A total of up to 180 participants (aiming for 128 completed participants) aged 16 years and older with T1D on insulin pump therapy or multiple daily injection therapy will be recruited through diabetes clinics in participating centres.
Participants will receive appropriate training to maximise the benefits of FSL and finger-stick glucose levels in self-management. The primary outcome is the difference in HbA1c between the two groups at 24 weeks. Secondary outcomes are time spent with glucose levels above and below target, as recorded by FSL, and other flash glucose-based metrics. Impact on quality of life, diabetes distress, mood, needle burden, disordered eating and treatment satisfaction will also be undertaken. Relative cost-effectiveness of FSL device compared with self-monitoring will also be assessed from a UK NHS perspective.
Summary of Results
The trial involved 156 people with type 1 diabetes who had above-target blood glucose levels. For 24 weeks, half of the participants monitored their blood glucose with Flash and the other half continued using finger prick testing. At the start of the study both groups had similar 3-month average blood glucose levels (assessed by an HbA1c blood test). After 24 weeks, those participants who used Flash had reduced their HbA1c from an average of 71.6 mmol/mol to 62.7 mmol/mol - a reduction of 8.49 mmol/mol. Lowering HbA1c by this amount can decrease the risk of developing diabetes complications in the future by up to 40%. In comparison, those in the finger prick group had reduced their HbA1c on average by only 2.2 mmol/mol by the end of the study. In addition, those using the Flash technology spent an extra 2 hours a day with their blood glucose levels in the target range and 80% less time with dangerously low blood glucose levels. We further discovered that Flash had a positive impact on quality of life. Participants in the Flash group reported they were happier with their diabetes treatment and that using the technology reduced the day-to-day burden and emotional strain of living with the often-relentless condition.REC name
North West - Greater Manchester West Research Ethics Committee
REC reference
19/NW/0081
Date of REC Opinion
21 Mar 2019
REC opinion
Further Information Favourable Opinion