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Prolongation of GLP-1 Adherence When Using Continuous Glucose Monitoring 800

Recruiting
Clinical Trial NCT06668935 is an observational study for Diabetes Mellitus that is recruiting. It started on 24 October 2024 with plans to enroll 800 participants. Led by Abbott Diabetes Care, it is expected to complete by 1 January 2027. The latest data from ClinicalTrials.gov was last updated on 15 January 2025.
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.
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 wil...Show More
Official Title

Prolongation of GLP-1 Adherence When Using Continuous Glucose Monitoring

Conditions
Diabetes Mellitus
Other Study IDs
  • ADC-US-RES-24254
NCT ID Number
NCT06668935
Start Date (Actual)
2024-10-24
Last Update Posted
2025-01-15
Completion Date (Estimated)
2027-01
Enrollment (Estimated)
800
Study Type
Observational
Status
Recruiting
Arms / Interventions
Participant Group/ArmIntervention/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.
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.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime 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
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  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.

  1. Subject is a member of the Study Staff.
  2. Subject has a diagnosis of type 1 or gestational diabetes.
  3. Subject is currently using or has previously used GLP-1 or GIP/GLP-1 drugs for any reason.
  4. Subject is currently using a Continuous Glucose Monitor (CGM) as their standard of care device to manage their diabetes.
  5. Subject has known allergy to medical grade adhesive, isopropyl alcohol and/or ethyl alcohol used to disinfect skin.
  6. Subject is taking any type of rapid-acting insulin, including Neutral Protamine Hagedorn (NPH) and premix insulin.
  7. 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.
  8. Subject currently is participating in another clinical trial.
  9. Subject is unsuitable for participation due to any other cause as determined by the Investigator
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Study Central Contact
Contact: Mohamed Mohamed Nada, PhD, 5107495416, [email protected]
Contact: Shridhara Karinka, PhD, 510 7495416, [email protected]
2 Study Locations in 1 Countries

Florida

East Coast Institute for Research, LLC, Jacksonville, Florida, 32216, United States
Rebecca Goldfaden, Pharm D, Contact, 904-854-1354, [email protected]
Wasim Deeb, MD, Principal Investigator
Recruiting
Excellence Medical and Research, Miami Gardens, Florida, 33169, United States
Alexander Martinez, OD, Contact, 786-320-5229, [email protected]
Miguel Trujillo, DNP, Principal Investigator
Recruiting