Prolongation of GLP-1 Adherence When Using Continuous Glucose Monitoring

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus
• Intervention / 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

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.

• Study Type: Observational
• Enrollment (Estimated): 800

Contacts and Locations

• Study Contact: Name: Mohamed Mohamed Nada, PhD; Phone Number: 5107495416; Email: adc.clinical@abbott.com
• Study Contact Backup: Name: Shridhara Karinka, PhD; Phone Number: 510 7495416; Email: adc.clinical@abbtott.com

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32216
      • Recruiting
      • East Coast Institute for Research, LLC
      • Principal Investigator: Wasim Deeb, MD
      • Contact: Rebecca Goldfaden, Pharm D; Phone Number: 904-854-1354; Email: rg@eastcoastresearch.net
    • Miami Gardens, Florida, United States, 33169
      • Recruiting
      • Excellence Medical and Research
      • Contact: Alexander Martinez, OD; Phone Number: 786-320-5229; Email: amartinez@emrclinic.com
      • Principal Investigator: Miguel Trujillo, DNP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Randomization to FSL 3 or Standard of Care; 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the length of time subjects in each group remain on a GLP-1 or GLP-1/GIP combination drug	The primary outcome is to see if the FreeStyle Libre 3 Continuous Glucose Monitoring System (FSL3) helps prolong the length of time people with diabetes maintain adherence to glucagon-like peptide 1 (GLP-1) and dual gastric inhibitory polypeptide/glucagon-like peptide 1 (GIP/GLP-1) agonists.	210 days

Collaborators and Investigators

• Sponsor: Abbott Diabetes Care

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: October 30, 2024
• First Submitted That Met QC Criteria: October 30, 2024
• First Posted (Actual): November 1, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 14, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Benzocaine
• Other Study ID Numbers: ADC-US-RES-24254

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes