Suspended

FREE CGMFreeStyle Libre Continuous Glucose Monitoring System Evaluation in Youth with Type 2 Diabetes

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Study Aim

This study aims to evaluate the ability, acceptability, appropriateness, and feasibility of using the FreeStyle Libre Continuous Glucose Monitoring System in youth with Type 2 Diabetes, by measuring the number of hours participants wear the device and view data on the mobile application.

What is being tested

FreeStyle Libre Continuous Glucose Monitor System

Device
Who is being recruted

Diabetes Mellitus+3

+ Diabetes Mellitus, Type 2

+ Endocrine System Diseases

From 8 to 20 Years
+17 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: January 2024
See protocol details

Summary

Principal SponsorUniversity of California, San Francisco
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 3, 2024

Actual date on which the first participant was enrolled.

This study is exploring the use of a new technology called the FreeStyle Libre Continuous Glucose Monitoring System for young people with Type 2 diabetes. The main goal is to see how well this system can help in managing blood sugar levels compared to traditional methods. The study is important because better monitoring of blood sugar can help reduce complications and improve quality of life for young people living with diabetes. Participants will initially wear a "blinded" glucose sensor for 14 days to gather baseline data without seeing the results themselves. After the initial 14 days, participants are randomly placed into one of two groups. One group will use the FreeStyle Libre 3 system, which includes a sensor worn on the skin and a mobile app that shows blood sugar levels. The other group will continue their usual practice of checking blood sugar with a glucometer. Participants in the first group will receive education on using the system and interpreting the data to make lifestyle changes. Both groups will have regular check-ins with their diabetes care team and participate in educational sessions. The study lasts six months, with some participants invited to share their experiences in a discussion group at the end. This feedback will help researchers understand the benefits and challenges of using such technology.

Official TitleFeasibility of the FreeStyle Libre Continuous Glucose Monitoring System in Youth With Type 2 Diabetes (FREE CGM)
NCT06089070
Principal SponsorUniversity of California, San Francisco
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 8 to 20 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Criteria

10 inclusion criteria required to participate
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% .

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7 exclusion criteria prevent from participating
Known history of adrenal insufficiency, or ongoing renal or hepatic disease.

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.

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

University of California San Francisco (UCSF)

San Francisco, United StatesOpen University of California San Francisco (UCSF) in Google Maps
SuspendedOne Study Center
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