CGM use in adults with type 2 diabetes on basal insulin.
Research type
Research Study
Full title
Real-time glucose monitoring using FreeStyle Libre 3 in adults with type 2 diabetes on basal insulin plus SGLT2 inhibitors and/or GLP-1.
IRAS ID
322870
Contact name
Emma Wilmot
Contact email
Sponsor organisation
Abbott Diabetes Care Ltd
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 7 months, 31 days
Research summary
This randomised controlled study is being conducted to determine if use of the FreeStyle Libre 3 Continuous Glucose Monitoring System (intervention group) helps improve glucose control (defined by change in HbA1c) compared to self-monitoring of blood glucose (control group) in adults with Type 2 diabetes who use basal (long acting or background) insulin and other glucose lowering medications. \n\nThe study consists of two distinct phases, each of 4 months duration. During the first, participants will self-manage insulin titration with health care guidance. During the last, more intensive therapy changes may be made in discussion with the health care team to improve glucose control. \n\nThroughout the study, all participants will have diabetes reviews with a diabetes specialist, bloods collected at different stages, and be asked a series of questions to understand impact on quality of life. All participants will also wear an activity tracker to help understand impact of changes to activity levels on glucose control. \n\nFor control participants there is an optional four-month extension phase, during which FreeStyle Libre 3 will be used.\n\nUp to 430 participants may be recruited to ensure 345 participants randomised, across up to 20 UK study sites.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
23/WM/0092
Date of REC Opinion
27 Apr 2023
REC opinion
Favourable Opinion