Continuous Glucose Monitoring System Feasibility in Youth With T2D

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.

Conditions

Type 2 Diabetes

Study Overview

Study Details

Study overview

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.

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

Continuous Glucose Monitoring System Feasibility in Youth With T2D

Condition
Type 2 Diabetes
Intervention / Treatment

-

Contacts and Locations

San Francisco

University of California San Francisco (UCSF), San Francisco, California, United States, 94158

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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. Naïve to CGM use.
  • 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.

Ages Eligible for Study

8 Years to 20 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of California, San Francisco,

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

Study Record Dates

2027-12-01