Prolongation of GLP-1 Adherence When Using Continuous Glucose Monitoring
Abbott Diabetes Care
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.
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Subject must be at least 18 years of age. 2. Subject must be able to read and understand English. 3. Subject must have a type 2 diabetes diagnosis. 4. In the investigator's opinion, subject must meet the criteria for beginning use of GLP-1 or GIP/GLP-1 medications for management of their diabetes. 5. Subject is beginning use of GLP-1 / GIP/GLP-1 medication for management of their diabetes. 6. Subject must be willing to allow venous samples to be obtained to test HbA1c. 7. Subject must be willing to either continue using their existing standard of care device or must be…
Interventions
- DeviceTo 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.
Locations (2)
- East Coast Institute for Research, LLCJacksonville, Florida
- Excellence Medical and ResearchMiami Gardens, Florida