Trials / Active Not Recruiting
Active Not RecruitingNCT05944432
CGM Use in Adults With Type 2 Diabetes on Basal Insulin
Real-Time Glucose Monitoring Using FreeStyle Libre 3 in Adults With Type 2 Diabetes On Basal Insulin Plus SGLT2 Inhibitor and/or GLP-1
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 470 (estimated)
- Sponsor
- Abbott Diabetes Care · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
The study will assess change in HbA1c as the primary endpoint. Other endpoints related to glycaemic control are included in the analyses. The study is split into two phases each of four months duration: participant-driven (phase 1) and HCP/therapy-driven (phase 2). Participants will be randomised to either FreeStyle Libre 3 or to continuation with their current SMBG device.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | FreeStyle Libre 3 Continuous Glucose Monitoring System. | Subjects will be randomised to use the FreeStyle Libre 3 system |
| DEVICE | Self monitoring of blood glucose | Subjects will be randomised to continue with their current glucose monitoring system |
Timeline
- Start date
- 2023-07-14
- Primary completion
- 2026-03-30
- Completion
- 2027-11-30
- First posted
- 2023-07-13
- Last updated
- 2026-02-12
Locations
25 sites across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT05944432. Inclusion in this directory is not an endorsement.