Using Continuous Glucose Monitoring to Improve Adherence to Diabetes Medications

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to determine if the FreeStyle Libre 3 Continuous Glucose Monitoring System (FSL3) can help individuals with type 2 diabetes maintain adherence to glucagon-like peptide 1 (GLP-1) and dual GIP/GLP-1 agonist therapies. Participants who are newly starting these medications will be randomized to either use the FSL3 system or continue with their standard diabetes management. The study will enroll up to 800 subjects across the United States, with a focus on evaluating the effectiveness of the FSL3 in prolonging adherence over approximately 210 days. Participants will wear a sensor on their upper arm and use a smartphone to monitor glucose levels throughout the study.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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.

    Exclusion Criteria:
11. Subject is a member of the Study Staff.
12. Subject has a diagnosis of type 1 or gestational diabetes.
13. Subject is currently using or has previously used GLP-1 or GIP/GLP-1 drugs for any reason.
14. Subject is currently using a Continuous Glucose Monitor (CGM) as their standard of care device to manage their diabetes.
15. Subject has known allergy to medical grade adhesive, isopropyl alcohol and/or ethyl alcohol used to disinfect skin.
16. Subject is taking any type of rapid-acting insulin, including Neutral Protamine Hagedorn (NPH) and premix insulin.
17. 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.
18. Subject currently is participating in another clinical trial.
19. Subject is unsuitable for participation due to any other cause as determined by the Investigator

Where it's running

• Helios Clinical Research
  Paradise Valley, Arizona, United States Recruiting
• East Coast Institute for Research, LLC
  Jacksonville, Florida, United States Recruiting
• Excellence Medical and Research
  Miami Gardens, Florida, United States Recruiting
• American Research Centers of Florida
  Pembroke Pines, Florida, United States Recruiting
• Cross Creek Medical Clinic, PA
  Fayetteville, North Carolina, United States Recruiting
• Medication Management
  Greensboro, North Carolina, United States Recruiting

Study contacts

• Study coordinator: Mohamed Mohamed Nada, PhD
• Email: adc.clinical@abbott.com
• Phone: 5107495416

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.