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RECRUITING

NCT06668935

Prolongation of GLP-1 Adherence When Using Continuous Glucose Monitoring

Sponsor: Abbott Diabetes Care

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

800

Start Date

2024-10-24

Completion Date

2027-01

Last Updated

2025-01-15

Healthy Volunteers

Conditions

Diabetes Mellitus

Interventions

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.

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 willing to use the FreeStyle Libre 3 Continuous Glucose Monitoring System to manage their diabetes throughout the duration of the study. 8. In the investigator's opinion, the subject must be able to follow the instructions provided to him/her by the study site and perform all study tasks as specified by the protocol. 9. Subject must be available to participate in all study visits. 10. Subject must be willing and able to provide written signed and dated informed consent. Exclusion Criteria: 11. Subject is a member of the Study Staff. 12. Subject has a diagnosis of type 1 or gestational diabetes. 13. Subject is currently using or has previously used GLP-1 or GIP/GLP-1 drugs for any reason. 14. Subject is currently using a Continuous Glucose Monitor (CGM) as their standard of care device to manage their diabetes. 15. Subject has known allergy to medical grade adhesive, isopropyl alcohol and/or ethyl alcohol used to disinfect skin. 16. Subject is taking any type of rapid-acting insulin, including Neutral Protamine Hagedorn (NPH) and premix insulin. 17. Subject has concomitant medical condition which, in the opinion of the investigator, could interfere with the study or present a risk to the safety or welfare of the subject or study staff. 18. Subject currently is participating in another clinical trial. 19. Subject is unsuitable for participation due to any other cause as determined by the Investigator

Locations (2)

East Coast Institute for Research, LLC

Jacksonville, Florida, United States

Excellence Medical and Research

Miami Gardens, Florida, United States