Actively Recruiting
Prolongation of GLP-1 Adherence Using FreeStyle Libre 3 Continuous Glucose Monitoring in Adults with Type 2 Diabetes Starting GLP-1 or GLP-1/GIP Therapy
Led by Abbott Diabetes Care · Updated on 2025-01-15
800
Participants Needed
2
Research Sites
114 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating whether using the FreeStyle Libre 3 Continuous Glucose Monitoring System (FSL3) can help people with type 2 diabetes stay on their glucagon-like peptide 1 (GLP-1) or GLP-1/glucose-dependent insulinotropic polypeptide (GIP) combination medications longer. This study is designed for adults newly starting these drug therapies to better manage their diabetes by monitoring glucose levels continuously. Participants will be randomly assigned to either use the FSL3 device or continue with their current standard diabetes care for about 210 days. The FSL3 device involves wearing a small sensor on the back of the upper arm that collects glucose readings paired with a smartphone. All participants will begin their prescribed GLP-1 or GLP-1/GIP medication and will be adjusted to the maximum tolerable dose as guided by their healthcare provider during the study. Throughout the study, participants will have regular visits and provide venous blood samples to measure HbA1c levels. Researchers will monitor how long each participant stays on their GLP-1 or GLP-1/GIP medication while using either the FSL3 or standard care. The study includes assessments of adherence to medication and overall safety to understand if continuous glucose monitoring supports longer use of these treatments in managing type 2 diabetes.
CONDITIONS
Official Title
Prolongation of GLP-1 Adherence When Using Continuous Glucose Monitoring
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
- Subject must meet criteria to begin GLP-1 or GIP/GLP-1 medication for diabetes management.
- Subject is starting GLP-1 or GIP/GLP-1 medication for diabetes.
- Subject must be willing to provide venous blood samples to test HbA1c.
- Subject must be willing to use either their current standard care device or the FreeStyle Libre 3 CGM during the study.
- Subject must be able to follow study instructions and complete all required tasks.
- Subject must be available for all study visits.
- Subject must be willing and able to give written informed consent.
You will not qualify if you...
- Subject is a member of the Study Staff.
- Subject has type 1 or gestational diabetes.
- Subject has used GLP-1 or GIP/GLP-1 drugs previously or currently.
- Subject currently uses a continuous glucose monitor as their standard care.
- Subject has known allergy to medical grade adhesive, isopropyl alcohol, or ethyl alcohol used in skin disinfection.
- Subject is taking rapid-acting insulin, including NPH and premix insulin.
- Subject has a medical condition that may interfere with the study or pose safety risks.
- Subject is currently enrolled in another clinical trial.
- Subject is unsuitable for participation for any other reason determined by the Investigator.
AI-Screening
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Trial Site Locations
Total: 2 locations
1
East Coast Institute for Research, LLC
Jacksonville, Florida, United States, 32216
Actively Recruiting
2
Excellence Medical and Research
Miami Gardens, Florida, United States, 33169
Actively Recruiting
Research Team
M
Mohamed Mohamed Nada, PhD
S
Shridhara Karinka, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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