FREE CGMFreeStyle Libre Continuous Glucose Monitoring System Evaluation in Youth with Type 2 Diabetes
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.
FreeStyle Libre Continuous Glucose Monitor System
Diabetes Mellitus+3
+ Diabetes Mellitus, Type 2
+ Endocrine System Diseases
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.20 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy 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
University of California San Francisco (UCSF)
San Francisco, United StatesOpen University of California San Francisco (UCSF) in Google Maps