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Continuous Glucose Monitoring for Type 2 Diabetes (FREE_CGM Trial)

N/A
Recruiting
Led By Shylaja Srinivasan, MD, MAS
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 8-20 years at the time of consent
Clinical diagnosis of type 2 diabetes
Must not have
Currently undergoing cancer treatment or systemic treatment with steroids
Plan for undergoing bariatric surgery during the study period
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial studies if young people with type 2 diabetes can better manage their condition with a continuous glucose monitor (CGM) system. 30 participants with 6 months of study each.

Who is the study for?
This trial is for young people aged 8-20 with Type 2 Diabetes, who have had the condition for at least a month and are on a stable medication regimen. They must be new to using CGM devices, willing to follow study procedures, and able to give informed consent. Those with certain autoimmune markers, pregnant or breastfeeding individuals, patients undergoing cancer treatment or steroid therapy, and those with significant mental illness or plans for bariatric surgery cannot participate.
What is being tested?
The study tests if youth with Type 2 Diabetes will use the FreeStyle Libre Continuous Glucose Monitor System regularly over six months. It aims to see if this influences their behavior and diabetes management decisions. The trial has two groups: one of twenty participants using the CGM system (treatment arm) and a control group of ten without it.
What are the potential side effects?
While not explicitly listed in your information provided, typical side effects from using a CGM may include skin irritation where the device attaches to the body or inaccurate readings that could affect diabetes management.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 8 and 20 years old.
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I have been diagnosed with type 2 diabetes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently receiving cancer treatment or taking steroids.
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I am planning to have weight loss surgery during the study.
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I have tested positive for pancreatic autoantibodies.
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I have a history of adrenal insufficiency, kidney, or liver disease.
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I do not have a mental illness or developmental delay that affects my ability to participate on my own.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Ability to use CGM
Acceptability of CGM use measured with Acceptability of Intervention Measure (AIM)
Appropriateness of CGM use measured with Intervention Appropriateness Measure
+1 more
Secondary study objectives
Change in BMI
Co-efficient of variation of glucose
Dietary measures
+13 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
Participants will wear the CGM sensor and have access to the data during the main part of the study.
Group II: ControlActive Control1 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.

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,587 Previous Clinical Trials
14,901,146 Total Patients Enrolled
Shylaja Srinivasan, MD, MASPrincipal InvestigatorUniversity of California, San Francisco
~18 spots leftby Dec 2027
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