ACTIVE_NOT_RECRUITING

Continuous Glucose Monitoring System Feasibility in Youth With T2D

Conditions

Type 2 Diabetes freestyle libre continuous glucose monitor T2D pediatric

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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

The primary scientific question of this proposal is to investigate whether youth with T2D will wear and interact with a continuous glucose monitor (CGM) system and whether this will influence behavior and management decisions. There will be 30 participants enrolled in the study. 20 in the treatment arm and 10 in the control. The length of study participation will be 6 months for each participant.

Official Title

Feasibility of the FreeStyle Libre Continuous Glucose Monitoring System in Youth With Type 2 Diabetes (FREE CGM)

Quick Facts

Study Start:2024-01-03

Study Completion:2027-12-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06089070

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:8 Years to 20 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion Criteria
1. Age 8- 20 years at the time of consent. 2. Clinical diagnosis of type 2 diabetes. 3. Duration of type 2 diabetes at least 4 weeks. 4. HbA1C ≥ 6.5% . 5. Stable medication regimen (No medication changes and no change in basal insulin dose by more than 20% in the 2 weeks prior to enrollment). 6. No use of CGM 90 days before screening visit. 7. English or Spanish speakers. 8. Willing to abide by recommendations and study procedures. 9. Willing and able to sign the Informed Consent Form (ICF) and/or has a parent or guardian willing and able to sign the ICF. 10. Participant and parent(s)/guardian(s) willingness to participate in all training sessions as directed by study staff. Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.	1. Pancreatic autoantibody positivity (GAD-65, insulin, IA-2, ICA 512, Zn-T8). 2. Plan for undergoing bariatric surgery during the study period. 3. Known history of significant mental illness or developmental delay impacting the ability to complete study activities independently. 4. Known history of adrenal insufficiency, or ongoing renal or hepatic disease. 5. Pregnancy or lactation. 6. Currently undergoing cancer treatment or systemic treatment with steroids. 7. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.

Inclusion Criteria

Exclusion Criteria

1. Age 8- 20 years at the time of consent.
2. Clinical diagnosis of type 2 diabetes.
3. Duration of type 2 diabetes at least 4 weeks.
4. HbA1C ≥ 6.5% .
5. Stable medication regimen (No medication changes and no change in basal insulin dose by more than 20% in the 2 weeks prior to enrollment).
6. No use of CGM 90 days before screening visit.
7. English or Spanish speakers.
8. Willing to abide by recommendations and study procedures.
9. Willing and able to sign the Informed Consent Form (ICF) and/or has a parent or guardian willing and able to sign the ICF.
10. Participant and parent(s)/guardian(s) willingness to participate in all training sessions as directed by study staff. Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.

1. Pancreatic autoantibody positivity (GAD-65, insulin, IA-2, ICA 512, Zn-T8).
2. Plan for undergoing bariatric surgery during the study period.
3. Known history of significant mental illness or developmental delay impacting the ability to complete study activities independently.
4. Known history of adrenal insufficiency, or ongoing renal or hepatic disease.
5. Pregnancy or lactation.
6. Currently undergoing cancer treatment or systemic treatment with steroids.
7. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.

Contacts and Locations

Principal Investigator

Shylaja Srinivasan, MD, MAS

PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Study Locations (Sites)

University of California San Francisco (UCSF)

San Francisco, California, 94158

United States

Collaborators and Investigators

Sponsor: University of California, San Francisco

Shylaja Srinivasan, MD, MAS, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

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 Date2024-01-03

Study Completion Date2027-12-01

Study Record Updates

Study Start Date2024-01-03

Study Completion Date2027-12-01

Terms related to this study

Keywords Provided by Researchers

freestyle libre
continuous glucose monitor
type 2 diabetes
T2D
pediatric

Additional Relevant MeSH Terms

Type 2 Diabetes