Using Continuous Glucose Monitoring to Improve Adherence to Diabetes Medications
Prolongation of GLP-1 Adherence When Using Continuous Glucose Monitoring
Abbott Diabetes Care · NCT06668935
This study is testing if using a continuous glucose monitor can help people with type 2 diabetes stick to their new medication plan better than those who don’t use it.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 800 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Abbott Diabetes Care (industry) |
| Locations | 2 sites (Jacksonville, Florida and 1 other locations) |
| Trial ID | NCT06668935 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have been diagnosed with type 2 diabetes and are beginning treatment with GLP-1 or GIP/GLP-1 medications.
Not a fit: Patients who do not have type 2 diabetes or are not starting GLP-1 or GIP/GLP-1 therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance medication adherence in patients with diabetes, leading to better management of their condition.
How similar studies have performed: Other studies have shown promise in using continuous glucose monitoring to improve diabetes management, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Jacksonville, Florida and 1 other locations
- East Coast Institute for Research, LLC — Jacksonville, Florida, United States (RECRUITING)
- Excellence Medical and Research — Miami Gardens, Florida, United States (RECRUITING)
Study contacts
- Study coordinator: Mohamed Mohamed Nada, PhD
- Email: adc.clinical@abbott.com
- Phone: 5107495416
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Diabetes Mellitus