Prolongation of GLP-1 Adherence When Using Continuous Glucose Monitoring

Recruiting now

Conditions studied: Diabetes Mellitus

In brief

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 facts

Study ID

NCT06668935

Run by

Abbott Diabetes Care

People needed

800

Starts

2024-10-24

Expected to finish

2027-01-01

Last updated by the study team

2025-01-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• East Coast Institute for Research, LLC — Jacksonville, Florida, United States (enrolling)
• Excellence Medical and Research — Miami Gardens, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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