NCT06668935

Prolongation of GLP-1 Adherence When Using Continuous Glucose Monitoring

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 800 (estimated)
• Sponsor: Abbott Diabetes Care · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is to see if the FreeStyle Libre 3 Continuous Glucose Monitoring System (FSL3) will help prolong the length of time people with diabetes maintain adherence to glucagon-like peptide 1 (GLP-1/GIP) agonists.

Detailed description

Subjects with type 2 diabetes who are newly beginning GLP-1 or GLP-1/GIP drug therapy will be randomized to use either FSL3 or their existing Standard of Care to manage their diabetes. Up to 800 subjects will be enrolled across the United States with 200 evaluable subjects in each group (intervention and control) for a total of 400 evaluable subjects. Subjects will be on the study approximately 210 days. Subjects will wear one sensor applied to the back of the upper arm and will have a paired smartphone that will be used to start the sensor and collect glucose readings.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	To utilize the FreeStyle Libre 3 Continuous Glucose Monitoring System (FSL3) to help prolong the length of time people with diabetes maintain adherence to GLP-1 and dual GIP/GLP-1 agonists	All subjects will then begin use of their prescribed GLP-1 or combination GIP/GLP-1 medication in accordance with the HCP's instructions. Subjects will be titrated to their maximum tolerable dose per the medication's approved titration schedule and according to their HCP's standard of care between Visits 2 and 3.

Timeline

• Start date: 2024-10-24
• Primary completion: 2026-10-01
• Completion: 2027-01-01
• First posted: 2024-11-01
• Last updated: 2025-01-15

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study