Prolongation of GLP-1 Adherence When Using Continuous Glucose Monitoring

Phase

N/A

Condition

Diabetes And Hypertension

Diabetes Prevention

Treatment

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

Clinical Study ID

NCT06668935

ADC-US-RES-24254

Ages > 18
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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 ofGLP-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 theirdiabetes.
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 caredevice or must be willing to use the FreeStyle Libre 3 Continuous Glucose MonitoringSystem to manage their diabetes throughout the duration of the study.
In the investigator's opinion, the subject must be able to follow the instructionsprovided to him/her by the study site and perform all study tasks as specified bythe protocol.
Subject must be available to participate in all study visits.
Subject must be willing and able to provide written signed and dated informedconsent.

Exclusion

Exclusion Criteria:

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 anyreason.
Subject is currently using a Continuous Glucose Monitor (CGM) as their standard ofcare device to manage their diabetes.
Subject has known allergy to medical grade adhesive, isopropyl alcohol and/or ethylalcohol used to disinfect skin.
Subject is taking any type of rapid-acting insulin, including Neutral ProtamineHagedorn (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 thesubject or study staff.
Subject currently is participating in another clinical trial.
Subject is unsuitable for participation due to any other cause as determined by theInvestigator

Study Design

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

October 24, 2024

January 31, 2027

Study 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.

Connect with a study center

East Coast Institute for Research, LLC
Jacksonville, Florida 32216
United States
Active - Recruiting
Excellence Medical and Research
Miami Gardens, Florida 33169
United States
Active - Recruiting

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