Interventional Active not recruiting
NCT05944432 on ClinicalTrials.gov
CGM Use in Adults With Type 2 Diabetes on Basal Insulin
Official title: Real-Time Glucose Monitoring Using FreeStyle Libre 3 in Adults With Type 2 Diabetes On Basal Insulin Plus SGLT2 Inhibitor and/or GLP-1
- Sponsor: Abbott (Germany)
- Enrollment: 469 (Actual)
- Study start: 2023-07-26 (Actual)
- Primary completion: 2026-02-19 (Actual)
- Study completion: 2027-11-30 (Estimated)
- Allocation: Randomized
- InterventionModel: Parallel
- Masking: None
- PrimaryPurpose: Treatment
Brief Summary
A prospective multi-centre, open-label, two arm, parallel design, superiority, pragmatic, randomised controlled trial, over an 8-month period. The purpose of this study is to determine whether continuous glucose monitoring using FreeStyle Libre 3 will improve HbA1c compared to SMBG over 16 weeks in adults with sub-optimally controlled (HbA1c 7.5-11%) Type 2 diabetes on basal therapy.
Following completion of the 8-month period for all participants, an optional non-interventional follow-up period will assess glycaemic control and treatment patterns over 24 months.
Conditions
- Diabetes Mellitus, Type 2
Intervention / Treatment
- Device: FreeStyle Libre 3 Continuous Glucose Monitoring System.
- Device: Self monitoring of blood glucose
Primary Outcome Measures
-
HbA1c
(16 weeks)
Difference between treatment groups in mean change from baseline in HbA1c.
Countries
United Kingdom
Locations and Investigators
- Tameside General Hospital, Ashton-under-Lyne, United Kingdom
- Royal United Hospital, Bath, United Kingdom
- Queen Elizabeth Hospital, Birmingham, United Kingdom
- Cambridge University Hospital (Addenbrookes), Cambridge, United Kingdom
- Darlington Memorial Hospital, Darlington, United Kingdom
- Royal Derby Hospital, Derby, United Kingdom
- Ninewells Hospital, Dundee, United Kingdom
- Princess Alexandra Hospital, Harlow, United Kingdom
- Northwick Park Hospital, Harrow, United Kingdom
- Hull Royal Infirmary, Hull, United Kingdom
- Ipswich Hospital, Ipswich, United Kingdom
- St James University Hospital, Leeds, United Kingdom
- Leicester General Hospital, Leicester, United Kingdom
- King's College Hospital, London, United Kingdom
- St Mary's Hospital, London, United Kingdom
- Manchester Royal Infirmary, Manchester, United Kingdom
- Norfolk and Norwich University Hospital, Norwich, United Kingdom
- Churchill Hospital, Oxford, United Kingdom
- Derriford Hospital, Plymouth, United Kingdom
- The Adam Practice, Poole, United Kingdom
- Queen Alexandra Hospital, Portsmouth, United Kingdom
- Northern General Hospital, Sheffield, United Kingdom
- Moorgreen Hospital, Southampton, United Kingdom
- Singleton Hospital, Swansea, United Kingdom
- Wishaw Hospital, Wishaw, United Kingdom
Study Officials
- Pamela Reid (Study Director) — Abbott Diabetes Care Ltd