Continuous Glucose Monitoring for Diabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether the FreeStyle Libre 3, a continuous glucose monitoring system, can help individuals with type 2 diabetes adhere to their medication plan involving GLP-1 (glucagon-like peptide-1 receptor agonists) or dual GLP-1/GIP (glucagon-like peptide-1 and glucose-dependent insulinotropic polypeptide receptor agonists) drugs. The goal is to determine if using this device extends the duration of medication adherence compared to the usual care routine. Participants will either use the FreeStyle Libre 3 or continue with their current diabetes management approach. This trial targets individuals who have recently started on GLP-1 or dual GLP-1/GIP drugs and are not already using a continuous glucose monitor.
As an unphased trial, this study provides a unique opportunity to explore innovative diabetes management strategies.
Do I have to stop taking my current medications for the trial?
The trial requires that you do not use rapid-acting insulin or any GLP-1 or GIP/GLP-1 drugs before starting. If you're on these medications, you may need to stop them to participate.
What prior data suggests that the FreeStyle Libre 3 Continuous Glucose Monitoring System is safe for people with diabetes?
Research has shown that the FreeStyle Libre 3 Continuous Glucose Monitoring System (FSL3) is generally safe to use. Studies have found that this system performs well and is easy for users to handle. The FSL3 provides real-time glucose readings directly to a smartphone, enhancing convenience and user-friendliness.
Although this trial lacks specific safety data, the FSL3 has been used in other contexts and received FDA approval, indicating likely safety. Users should consider factors such as sensor removal and avoid using the device during MRI procedures. These are common considerations for many medical devices. Overall, existing data suggest that the FSL3 is safe for most people.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it's exploring how continuous glucose monitoring (CGM) with the FreeStyle Libre 3 (FSL3) could enhance adherence to GLP-1 or dual GLP-1/GIP therapies for people with type 2 diabetes. Unlike traditional glucose monitoring methods that require fingersticks, the FSL3 offers real-time glucose data without the hassle, which can make it easier for patients to manage their diabetes consistently. By potentially improving adherence to medication, this approach could lead to better blood sugar control and overall health outcomes.
What evidence suggests that the FreeStyle Libre 3 Continuous Glucose Monitoring System is effective for diabetes management?
This trial will compare the FreeStyle Libre 3 (FSL3) Continuous Glucose Monitoring System with the Standard of Care (SOC) for managing diabetes in participants newly beginning GLP-1 or dual GLP-1/GIP drug therapy. Studies have shown that the FSL3 helps people manage their blood sugar levels effectively. Research indicates that FSL3 provides accurate blood sugar readings, which is crucial for people with type 2 diabetes. In one study, a similar device led to lower average blood sugar levels (HbA1c) over three months. This finding suggests that FSL3 could assist individuals in adhering to their diabetes medication by offering real-time blood sugar information, simplifying daily management of their condition.678910
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to use either the FreeStyle Libre 3 Continuous Glucose Monitoring System or their existing Standard of Care to manage their diabetes
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- FreeStyle Libre 3 Continuous Glucose Monitoring System
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Subjects with type 2 diabetes who are newly beginning GLP-1 or dual GLP-1/GIP drug therapy will be randomized to use either the FSL3 or their existing Standard of Care (SOC) to manage their diabetes.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Abbott Diabetes Care
Lead Sponsor
Robert B. Ford
Abbott Diabetes Care
Chief Executive Officer since 2020
Bachelor's degree from Boston College, MBA from UC Berkeley, Haas School of Business
Dr. Mahmood Kazemi
Abbott Diabetes Care
Chief Medical Officer
Bachelor's and Master's degrees from Stanford University, MD from the University of California, San Francisco
Citations
Accuracy of the Third Generation of a 14-Day Continuous ...
The FSL3 CGM system demonstrated accurate performance across the dynamic glycemic range during the 14-day sensor wear period.
time glucose monitoring using FreeStyle Libre 3 on ...
ABSTRACT. Introduction Effective management of type 2 diabetes mellitus (T2DM) consists of lifestyle modification and therapy optimisation.
Continuous glucose monitoring in noninsulin‐treated type 2 ...
In a study of 47 non-insulin users, Reed et al. found that 3 months of G6 use was associated with significant decreases in mean HbA1c (8.4%–6.9 ...
The Use of Freestyle Libre Glucose Monitoring System and ...
However, at six months, the median HbA1c was 9.30% (IQR: 8.38-9.90%), showing a slight increase compared to the three-month follow-up. Therefore ...
Impact of real-time glucose monitoring using FreeStyle Libre 3 ...
The FreeDM2 study will provide information on the efficacy of real-time CGM using FSL3 on changes in HbA1c among adults with T2DM managed with basal insulin ...
Safety Information | The FreeStyle Libre System
Read safety information regarding your FreeStyle Libre 14 day system, including MRI contraindications, insulin contraindications, and sensor removal ...
FreeStyle Libre 3 System
Get the world's smallest sensor, performance you can count on and readings directly on your smartphone with the FreeStyle Libre 3 system.
Effectiveness, safety and costs of the FreeStyle Libre glucose ...
This study aimed to evaluate the effectiveness, safety and costs of FreeStyle Libre (FSL) glucose monitoring system for children and adolescents ...
User's Manual
The FreeStyle Libre 3 Continuous Glucose Monitoring System is a real time continuous glucose monitoring (CGM) device with alarms capability indicated for the ...
A 510(k) Number K233537 B Applicant Abbo
The FreeStyle Libre 3 Continuous Glucose Monitoring System is a real time continuous glucose monitoring (CGM) device with alarms capability indicated for the ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.