Continuous Glucose Monitoring System Feasibility in Youth With T2D

NCT06089070 | Active Not Recruiting FDA Device

• 1 other identifier: 22-38272
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

freestyle libre; continuous glucose monitor; type 2 diabetes; T2D; pediatric

Outcome Measures

Primary Outcomes (4)

• Ability to use CGM

  Use of CGM measured by number of hours participants in the intervention arm wear the CGM device and view data on the mobile application.

  Measured at 6 months

• Acceptability of CGM use measured with Acceptability of Intervention Measure (AIM)

  The perception that CGM use is agreeable or satisfactory measured with the 4-item Acceptability of Intervention Measure (AIM). Greater the score, higher the acceptability

  Measured at 6 months

• Appropriateness of CGM use measured with Intervention Appropriateness Measure

  The perceived fit of the CGM to improve diabetes related metrics measured with the 4-item Intervention Appropriateness Measure (IAM). Greater the score, higher the appropriateness of CGM use

  Measured at 6 months

• Feasibility of CGM use measured with Feasibility of Intervention Measure.

  The extent to which a CGM study can be successfully carried out measured with 4-item Feasibility of Intervention Measure (FIM). The higher the score, the greater the feasibility of CGM use

  Measured at 6 months

Secondary Outcomes (16)

• Glycemic change

  Baseline (0) to 6 months

• Time in target glucose range

  Baseline (0) to 6 months

• Time above high glucose range

  Baseline (0) to 6 months

• Time above glucose range

  Baseline (0) to 6 months

• Time below glucose range

  Baseline (0) to 6 months

Study Arms (2)

Control

NO INTERVENTION

Participants will not have access to view the data from the CGM sensor during the screening period, nor during the main part of the study.

Intervention

EXPERIMENTAL

Participants will wear the CGM sensor and have access to the data during the main part of the study.

Device: FreeStyle Libre Continuous Glucose Monitor System

Interventions

FreeStyle Libre Continuous Glucose Monitor System DEVICE

Continuous Glucose Monitor System for people with Type 2 Diabetes

Intervention

Eligibility Criteria

• Age: 8 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 8- 20 years at the time of consent.
• Clinical diagnosis of type 2 diabetes.
• Duration of type 2 diabetes at least 4 weeks.
• HbA1C ≥ 6.5% .
• Stable medication regimen (No medication changes and no change in basal insulin dose by more than 20% in the 2 weeks prior to enrollment).
• No use of CGM 90 days before screening visit.
• English or Spanish speakers.
• Willing to abide by recommendations and study procedures.
• Willing and able to sign the Informed Consent Form (ICF) and/or has a parent or guardian willing and able to sign the ICF.
• 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.

You may not qualify if:

• Pancreatic autoantibody positivity (GAD-65, insulin, IA-2, ICA 512, Zn-T8).
• Plan for undergoing bariatric surgery during the study period.
• Known history of significant mental illness or developmental delay impacting the ability to complete study activities independently.
• Known history of adrenal insufficiency, or ongoing renal or hepatic disease.
• Pregnancy or lactation.
• Currently undergoing cancer treatment or systemic treatment with steroids.
• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California San Francisco (UCSF)

San Francisco, California, 94158, United States

Location

Related Publications (4)

• Wagenknecht LE, Lawrence JM, Isom S, Jensen ET, Dabelea D, Liese AD, Dolan LM, Shah AS, Bellatorre A, Sauder K, Marcovina S, Reynolds K, Pihoker C, Imperatore G, Divers J; SEARCH for Diabetes in Youth study. Trends in incidence of youth-onset type 1 and type 2 diabetes in the USA, 2002-18: results from the population-based SEARCH for Diabetes in Youth study. Lancet Diabetes Endocrinol. 2023 Apr;11(4):242-250. doi: 10.1016/S2213-8587(23)00025-6. Epub 2023 Feb 28.

  PMID: 36868256 RESULT

• TODAY Study Group; Bjornstad P, Drews KL, Caprio S, Gubitosi-Klug R, Nathan DM, Tesfaldet B, Tryggestad J, White NH, Zeitler P. Long-Term Complications in Youth-Onset Type 2 Diabetes. N Engl J Med. 2021 Jul 29;385(5):416-426. doi: 10.1056/NEJMoa2100165.

  PMID: 34320286 RESULT

• TODAY Study Group; Zeitler P, Hirst K, Pyle L, Linder B, Copeland K, Arslanian S, Cuttler L, Nathan DM, Tollefsen S, Wilfley D, Kaufman F. A clinical trial to maintain glycemic control in youth with type 2 diabetes. N Engl J Med. 2012 Jun 14;366(24):2247-56. doi: 10.1056/NEJMoa1109333. Epub 2012 Apr 29.

  PMID: 22540912 RESULT

• U.K. prospective diabetes study 16. Overview of 6 years' therapy of type II diabetes: a progressive disease. U.K. Prospective Diabetes Study Group. Diabetes. 1995 Nov;44(11):1249-58.

  PMID: 7589820 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Shylaja Srinivasan, MD, MAS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: N/A both study team and participants will know the randomization assignment as to which group they are in.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Feasibility study of the FreeStyle Libre Continuous Glucose Monitoring System in Youth with Type 2 Diabetes

Study Record Dates

• First Submitted: October 12, 2023
• First Posted: October 18, 2023
• Study Start: January 3, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)