Continuous Glucose Monitoring for Type 2 Diabetes
(FREE CGM Trial)
Recruiting in Palo Alto (17 mi)
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of California, San Francisco
Must not be taking: Steroids
Disqualifiers: Mental illness, Renal disease, others
No Placebo Group
Approved in 5 Jurisdictions
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it requires that your medication regimen is stable, meaning no changes in medication or insulin dose in the two weeks before joining the study.
What data supports the effectiveness of the treatment FreeStyle Libre Continuous Glucose Monitor System for Type 2 Diabetes?
Research shows that the FreeStyle Libre system can help people with diabetes better control their blood sugar levels and improve their quality of life by preventing extreme highs and lows in blood sugar. It has been effective in both Type 1 and Type 2 diabetes, helping users manage their condition more effectively.
12345Is the FreeStyle Libre Continuous Glucose Monitoring System safe for humans?
The FreeStyle Libre system, used for monitoring glucose levels, has been widely used and studied in people with diabetes, showing it is generally safe for human use. It helps manage blood sugar levels and improve quality of life without significant safety concerns reported in the studies.
25678How does continuous glucose monitoring differ from other treatments for type 2 diabetes?
Continuous glucose monitoring (CGM) systems like the FreeStyle Libre provide real-time glucose readings and alerts for abnormal levels, unlike traditional methods that require manual blood sugar checks. This allows for better management of glucose levels and prevention of complications by automatically tracking changes and trends.
23578Eligibility Criteria
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.Inclusion Criteria
I am between 8 and 20 years old.
I, and if under 18, my parent/guardian, agree to attend all study sessions and follow instructions.
My medications, including insulin, have been stable for the last 2 weeks.
+7 more
Exclusion Criteria
I am currently receiving cancer treatment or taking steroids.
I am planning to have weight loss surgery during the study.
I have tested positive for pancreatic autoantibodies.
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
1 visit (in-person)
Blinding Period
Participants wear a blinded CGM sensor for baseline data collection
2 weeks
1 visit (in-person)
Treatment
Participants are randomized into intervention or control groups; intervention group uses CGM with app access, control group continues standard care
6 months
Monthly phone check-ins, clinic visits at 3 and 6 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Optional Focus Group
Participants invited to discuss their experience with the technology in an online focus group
Participant Groups
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.
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 Clinic Near You
Research Locations NearbySelect from list below to view details:
University of California San Francisco (UCSF)San Francisco, CA
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Who Is Running the Clinical Trial?
University of California, San FranciscoLead Sponsor
References
Reduction in HbA1c using professional flash glucose monitoring in insulin-treated type 2 diabetes patients managed in primary and secondary care settings: A pilot, multicentre, randomised controlled trial. [2022]Analyse the effects of professional flash glucose monitoring system (FreeStyle Libre Pro™) on glycaemic control in insulin-treated type 2 diabetes.
A Clinical Trial of the Accuracy and Treatment Experience of the Flash Glucose Monitor FreeStyle Libre in Adults with Type 1 Diabetes. [2022]In Sweden, FreeStyle Libre a flash glucose monitoring system came onto the market in 2014 as a complement to self-monitoring of blood glucose. The aim of this study was to evaluate the accuracy and treatment experience of the FreeStyle Libre system.
Comparison of glucose monitoring between Freestyle Libre Pro and iPro2 in patients with diabetes mellitus. [2023]Flash and continuous glucose monitoring systems are becoming prevalent in clinical practice. We directly compared a flash glucose monitoring system (FreeStyle Libre Pro [FSL-Pro]) with a continuous glucose monitoring system (iPro2) in patients with diabetes mellitus.
Performance of the FreeStyle Libre Flash glucose monitoring system in patients with type 1 and 2 diabetes mellitus. [2022]To evaluate the performance of the FreeStyle Libre Flash continuous glucose monitoring (FSL-CGM) system against established central laboratory methods.
Clinical Approach to Flash Glucose Monitoring: An Expert Recommendation. [2021]The flash glucose monitoring (FGM) system FreeStyle Libre® is a device that measures interstitial glucose in a very simple way and indicates direction and speed of glucose change. This allows persons with diabetes to prevent hypoglycemic and hyperglycemic events. Scientific evidence indicates that the system can improve glycemic control and quality of life. To obtain the maximum benefit, it is necessary to properly handle glucose values and trends. Due to the generalization of the system use, the purpose of the document is to provide recommendations for the optimal use of the device, not only in the management of glucose values and trends but also in the prevention of hypoglycemia, actuation in exercise, special situations, and retrospective analysis of the glucose data, among others.
Accuracy of a Flash Glucose Monitoring System in Diabetic Dogs. [2022]A novel flash glucose monitoring system (FGMS) (FreeStyle Libre, Abbott, UK) was recently developed for humans. It continuously measures the interstitial glucose (IG) concentrations for 14 days.
Meta-analysis of average change in laboratory-measured HbA1c among people with type 1 diabetes mellitus using the 14 day Flash Glucose Monitoring System. [2022]FreeStyle Libre™ Flash Glucose Monitoring System (Flash GM), a novel, sensor-based, factory-calibrated system has been compared with self-monitoring of blood glucose in a well-controlled adult type 1 diabetes mellitus (T1D) population (HbA1c ≤ 7.5%, 58 mmol/mol), in a randomized controlled trial (RCT). The need for RCTs to recruit homogenous patients and for a well-controlled environment may not necessarily reflect use of a new technology in real clinical practice.
Effect of Using Additional Readers for Flash Glucose Monitoring System on Metabolic Control, Safety, and the Incidence of Complications in Patients With Diabetes Mellitus. [2021]The FreeStyle Libre is a flash glucose monitoring (FGM) system, and glucose levels are measured when the reader is brought to the sensor. Additional readers allow for the conversion into a continuous glucose monitoring (CGM) system. These transmitters read data from the sensor and send them to a bluetooth-enabled device thanks to which the user acquires glucose measurements automatically. This modification allows the patient to receive alerts when blood glucose values are abnormal.