Prolongation of GLP-1 Adherence When Using Continuous Glucose Monitoring

Abbott

Status: Enrolling

Conditions: Diabetes Mellitus

Treatments: 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

Study type: Observational

Funder types: Industry

Identifiers

NCT06668935

ADC-US-RES-24254

Details and patient eligibility

About

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.

Full 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.

Enrollment: 800 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

800 participants in 1 patient group

Randomization to FSL 3 or Standard of Care

Description:

Subjects with type 2 diabetes who are newly beginning GLP-1 or dual GLP-1/GIP drug therapy will be randomized to use either the FSL3 or their existing Standard of Care (SOC) to manage their diabetes.

Treatment:

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