Prolongation of GLP-1 Adherence When Using Continuous Glucose Monitoring

NCT06668935 | Recruiting FDA Device

• 1 other identifier: ADC-US-RES-24254
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

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 DEVICE

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.

Randomization to FSL 3 or Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Subject must be at least 18 years of age.
• Subject must be able to read and understand English.
• Subject must have a type 2 diabetes diagnosis.
• 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.
• Subject is beginning use of GLP-1 / GIP/GLP-1 medication for management of their diabetes.
• Subject must be willing to allow venous samples to be obtained to test HbA1c.
• 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.
• 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.
• Subject must be available to participate in all study visits.
• Subject must be willing and able to provide written signed and dated informed consent.

You may not qualify if:

• Subject is a member of the Study Staff.
• Subject has a diagnosis of type 1 or gestational diabetes.
• Subject is currently using or has previously used GLP-1 or GIP/GLP-1 drugs for any reason.
• Subject is currently using a Continuous Glucose Monitor (CGM) as their standard of care device to manage their diabetes.
• Subject has known allergy to medical grade adhesive, isopropyl alcohol and/or ethyl alcohol used to disinfect skin.
• Subject is taking any type of rapid-acting insulin, including Neutral Protamine Hagedorn (NPH) and premix insulin.
• 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.
• Subject currently is participating in another clinical trial.
• Subject is unsuitable for participation due to any other cause as determined by the Investigator

Sponsors & Collaborators

• Abbott Diabetes Care: lead

Study Sites (2)

East Coast Institute for Research, LLC

Jacksonville, Florida, 32216, United States

RECRUITING

Excellence Medical and Research

Miami Gardens, Florida, 33169, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Mohamed Mohamed Nada, PhD

CONTACT

5107495416; adc.clinical@abbott.com

Shridhara Karinka, PhD

CONTACT

510 7495416; adc.clinical@abbtott.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: November 1, 2024
• Study Start: October 24, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: January 15, 2025

Record last verified: 2024-10

Locations

US (2)