350 Participants Needed

FreeStyle Libre System for Type 2 Diabetes

Recruiting at 3 trial locations
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Abbott Diabetes Care
Must be taking: Metformin, SGLT-2 inhibitors
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify that you need to stop taking your current diabetes medications, but you must agree to not change your diabetes medications for 3 months.

What data supports the effectiveness of the FreeStyle Libre System for Type 2 Diabetes?

Research shows that using the FreeStyle Libre system helps lower HbA1c (a measure of blood sugar control) in people with type 2 diabetes, and these benefits can last for up to 24 months.12345

Is the FreeStyle Libre System safe for humans?

The FreeStyle Libre System has been evaluated for safety in people with type 1 and type 2 diabetes, and it is generally considered safe for use in monitoring glucose levels at home.13678

How is the FreeStyle Libre System treatment different from other treatments for type 2 diabetes?

The FreeStyle Libre System is unique because it uses a sensor to monitor glucose levels without the need for finger-pricks, and it can be enhanced with additional readers to provide continuous glucose monitoring and alerts for abnormal glucose levels. This system, combined with a food app, helps users manage their diabetes more effectively by providing real-time data and insights into their glucose levels.6791011

What is the purpose of this trial?

A multi-center, randomized, prospective, non-significant risk study to compare the impact of the FreeStyle Libre Flash Glucose Monitoring System with and without a food logging smartphone application on reducing time above 180 mg/dL in subjects with type 2 diabetes who are not adequately controlled on their existing oral anti-diabetes medication regimen.

Research Team

SA

Shridhara A Karinka, PhD

Principal Investigator

Abbott Diabetes Care Inc

Eligibility Criteria

This trial is for adults with type 2 diabetes who have high blood sugar levels despite taking certain oral medications. Participants need to own a smartphone, be willing to track their diet and lifestyle changes, and not change their diabetes medication during the study. Pregnant individuals, those on insulin or sulfonylurea drugs, or with allergies to medical adhesives/isopropyl alcohol cannot join.

Inclusion Criteria

Your HbA1c level is between 7.5% and 12%.
I am willing to change my diet and lifestyle based on health advice and glucose data.
I agree not to change my diabetes medications for 3 months.
See 3 more

Exclusion Criteria

I have skin conditions that could affect glucose monitoring device placement.
Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin
Subject is known to be pregnant at the time of study enrollment (applicable to female subjects only)
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the FreeStyle Libre Flash Glucose Monitoring System, with or without a food logging app, to manage their diabetes

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • FreeStyle Libre System
  • FreeStyle Libre System plus food app
Trial Overview The study compares two approaches: using the FreeStyle Libre Flash Glucose Monitoring System alone versus pairing it with a food logging app. The goal is to see which method better reduces periods of high blood sugar in people whose condition isn't well-controlled by oral meds.
Participant Groups
2Treatment groups
Active Control
Group I: FreeStyle LibreActive Control1 Intervention
Subjects will be randomized to use the FreeStyle Libre Flash Glucose Monitoring System to manage their diabetes.
Group II: FreeStyle Libre plus food loggingActive Control1 Intervention
Subjects will be randomized to use the FreeStyle Libre Flash Glucose Monitoring System and a food logging smartphone application to manage their diabetes.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Abbott Diabetes Care

Lead Sponsor

Trials
67
Recruited
25,600+

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

Findings from Research

In a study of 86 patients with type 1 diabetes using the Freestyle Libre 2 (FSL2) system for 12 weeks, significant improvements were observed in glucose metrics, including a reduction in low glucose events and an increase in time spent within the target glucose range.
Patients reported high satisfaction with the FSL2 system, indicating it provided benefits with minimal discomfort, suggesting that it is a favorable option for continuous glucose monitoring in managing type 1 diabetes.
Assessment of Patient-reported Satisfaction and Metabolic Outcomes Following Initiation of the Second Generation of Flash Glucose Monitoring in Patients with Type 1 DiabetesAl Hayek, A., Robert, AA., Alzahrani, WM., et al.[2023]
The FreeStyle Navigator Continuous Glucose Monitoring System was found to be safe and effective for adults with type 1 or 2 diabetes, significantly reducing time spent in hypoglycemia by 55% during the unmasked period of the study.
Participants reported high satisfaction with the system, and the accuracy of glucose readings was validated, with 77.2% of results falling in the clinically acceptable Clarke error grid zone A, indicating reliable monitoring for better glycemic control.
Evaluation of a continuous glucose monitoring system for home-use conditions.Bode, B., Silver, M., Weiss, R., et al.[2019]
In a study of 47 patients aged 13-21 with type 1 diabetes using insulin pumps, the introduction of Freestyle Libre 2 (FSL2) significantly increased the frequency of glucose monitoring from 2.4 times per day to 8.2 times per day over 12 weeks (p < 0.001).
The use of FSL2 also led to improvements in diabetes self-management practices and a reduction in hemoglobin A1c levels from 8.3% to 7.9%, indicating better metabolic control, although this change was not statistically significant (p = 0.064).
Effectiveness of the freestyle libre 2 flash glucose monitoring system on diabetes-self-management practices and glycemic parameters among patients with type 1 diabetes using insulin pump.Al Hayek, AA., Robert, AA., Al Dawish, MA.[2022]

References

1.United Arab Emiratespubmed.ncbi.nlm.nih.gov
Assessment of Patient-reported Satisfaction and Metabolic Outcomes Following Initiation of the Second Generation of Flash Glucose Monitoring in Patients with Type 1 Diabetes [2023]
Reductions in HbA1c with Flash Glucose Monitoring Are Sustained for up to 24 Months: A Meta-Analysis of 75 Real-World Observational Studies. [2022]
Evaluation of a continuous glucose monitoring system for home-use conditions. [2019]
Effectiveness of the freestyle libre 2 flash glucose monitoring system on diabetes-self-management practices and glycemic parameters among patients with type 1 diabetes using insulin pump. [2022]
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]
Evaluating a Glucose-Sensor-Based Tool to Help Clinicians and Adults With Type 1 Diabetes Improve Self-Management Skills. [2019]
A Clinical Trial of the Accuracy and Treatment Experience of the Flash Glucose Monitor FreeStyle Libre in Adults with Type 1 Diabetes. [2022]
Comparing Glucose Outcomes Following Face-to-Face and Remote Initiation of Flash Glucose Monitoring in People Living With Diabetes. [2023]
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]
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]
Improved well-being and decreased disease burden after 1-year use of flash glucose monitoring (FLARE-NL4). [2023]
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