RECRUITING

Prolongation of GLP-1 Adherence When Using Continuous Glucose Monitoring

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Prolongation of GLP-1 Adherence When Using Continuous Glucose Monitoring

Quick Facts

Study Start:2024-11

Study Completion:2027-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06668935

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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

Inclusion Criteria

Exclusion 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.

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

Contacts and Locations

Study Contact

Mohamed Mohamed Nada, PhD

CONTACT

5107495416

adc.clinical@abbott.com

Shridhara Karinka, PhD

CONTACT

510 7495416

adc.clinical@abbtott.com

Study Locations (Sites)

East Coast Institute for Research, LLC

Jacksonville, Florida, 32216

United States

Excellence Medical and Research

Miami Gardens, Florida, 33169

United States

Collaborators and Investigators

Sponsor: Abbott Diabetes Care

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11

Study Completion Date2027-01

Study Record Updates

Study Start Date2024-11

Study Completion Date2027-01

Terms related to this study

Additional Relevant MeSH Terms

Diabetes Mellitus