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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured at 6 months

Awards & highlights

FREE_CGM Trial 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.Check my eligibility

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.See study design

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.

FREE_CGM Trial 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.

FREE_CGM Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured at 6 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

Change in BMI

Co-efficient of variation of glucose

Dietary measures

+13 more

FREE_CGM 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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor

2,507 Previous Clinical Trials

15,238,545 Total Patients Enrolled

Shylaja Srinivasan, MD, MASPrincipal InvestigatorUniversity of California, San Francisco

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria need to be met in order for a person to qualify as a participant of this research study?

"To be considered, potential participants must have been diagnosed with Type-2 diabetes and lie within the 8 to 20 age range. This project is looking for 30 enrollees in total."

Answered by AI

Is this research endeavor actively recruiting participants?

"The clinical trial appears to have been posted on December 1st 2023 and last updated October 12th of the same year. Based off this information, it seems that they are not currently looking for patients; however, there remain 883 other trials actively searching for candidates."

Answered by AI

What is the ultimate objective of this clinical investigation?

"The main consideration for this trial is the acceptability of CGM usage which will be monitored over a period of 6 months. Additionally, researchers are looking at patients' time in target glucose range (70-180 mg/dL), Time above high glucose range (>250mg/dl) and Time above glucose range (181-250 mg/dL)."

Answered by AI

Does the study offer enrollment to geriatric participants?

"This medical study only permits 8 to 20 year-olds as participants. The trial records indicate that 44 trials are dedicated to patients aged younger than 18, and 764 for those above 65 years of age."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Continuous Glucose Monitoring System Feasibility in Youth With T2D

2023. "Continuous Glucose Monitoring System Feasibility in Youth With T2D". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06089070.

All > Type 2 Diabetes