Diabetes Monitoring Device Study

Recruiting at 3 trial locations

Overseen By Mohamed Nada, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Abbott Diabetes Care

Disqualifiers: Pregnancy, Dialysis, Allergy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

550 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates the safety of the FreeStyle Libre 2, a flash glucose monitoring system, for children and young adults managing diabetes. It examines how effectively this system helps users track their blood sugar levels. Individuals with type 1 or type 2 diabetes for at least three months, who have not used a continuous glucose monitor in the past six months, may qualify. This trial offers an alternative for those currently using finger-prick blood tests to manage their diabetes. As a Phase 3 trial, it represents the final step before FDA approval, allowing participants to contribute to the validation of a potentially groundbreaking monitoring system.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team to get a clear answer.

What prior data suggests that the FreeStyle Libre 2 Flash Glucose Monitoring System is safe for managing diabetes in pediatric and young adult patients?

Research has shown that the FreeStyle Libre 2 Flash Glucose Monitoring System is generally safe for managing diabetes. The FDA has approved it for adults, indicating it meets specific safety standards for them. For children and young adults, a few considerations are necessary. Some studies suggest the device might not be as accurate when blood sugar levels are very low. This is crucial because incorrect readings could lead to wrong decisions about managing diabetes. Additionally, caution is advised when using the device near strong magnetic fields, such as those from MRI machines, and care should be taken when removing the sensor to avoid skin irritation. Overall, while some precautions are necessary, most people tolerate the system well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The FreeStyle Libre 2 Flash Glucose Monitoring System is unique because it allows for continuous glucose monitoring without the need for routine finger pricks, which is a game-changer for young patients managing diabetes. Unlike traditional methods that require multiple daily fingerstick tests, this system uses a small sensor worn on the skin to provide real-time glucose readings. Researchers are excited about its potential to improve quality of life and glucose control, making diabetes management less intrusive and more accurate for pediatric and young adult patients.

What evidence suggests that the FreeStyle Libre 2 Flash Glucose Monitoring System is effective for managing diabetes?

Research shows that the FreeStyle Libre 2 Flash Glucose Monitoring System can help people manage diabetes more effectively. Studies have found that using this system can improve blood sugar control and lower A1C levels by about 0.9% within 3 to 6 months, leading to more stable blood sugar levels over time. The system benefits both Type 1 and Type 2 diabetes management. However, some research suggests that its accuracy in measuring glucose levels may not be perfect. ^{6 7 8 9 10}

Who Is on the Research Team?

Shridhara Karinka, PhD

Principal Investigator

Abbott Diabetes Care

Are You a Good Fit for This Trial?

Inclusion Criteria

Are you located in one of the following four states: Pennsylvania, Massachusetts, Colorado, or Florida

Are you (or your child) between 4-30 years old?

Are you (or your child) able to visit a Quest Laboratory for a blood draw at the time of enrollment and at 6 months after enrollment?

Exclusion Criteria

Have you (or your child) used a Continuous Glucose Monitor in the past 6 months?

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants and/or their caregivers utilize the FreeStyle Libre 2 Flash Glucose Monitoring System for managing diabetes

6 months

Monthly visits and/or phone calls

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• FreeStyle Libre 2 Flash Glucose Monitoring System

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

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34488057/

Effectiveness of the freestyle libre 2 flash glucose ... Using FSL2 was found to raise the patients' DSM levels and improved metabolic control.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S187140212100285X

Effectiveness of the freestyle libre 2 flash glucose ... Using Freestyle Libre 2 (FSL 2) was found to raise the patients' Diabetes Self-Management levels. Using FSL 2 was improved the metabolic control such as ...

3. freestyleprovider.abbott freestyleprovider.abbott/us-en/outcomes.html

Adult & Pediatric Outcomes FreeStyle Libre CGM systems make it easy to support better outcomes by enabling greater glucose control* · 0.9% A1C reduction within 3 to 6 months among patients ...

4. provider.freestyle.abbott provider.freestyle.abbott/ca-en/proven-outcomes.html

Proven Outcomes | Healthcare Professional Clinically proven in patients with T1D and T2D. Both real-world evidence and clinical trial results show improved outcomes with the FreeStyle Libre 2 system.

5. mdpi.com mdpi.com/1424-8220/24/17/5769

Analytical Performance of the FreeStyle Libre 2 Glucose ... Taken together, the results of our study reveal that the accuracy of the FreeStyle Libre 2 sensor in measuring glucose levels is not optimal ...

6. freestyle.abbott freestyle.abbott/us-en/safety-information.html

Safety Information | The FreeStyle Libre System Read safety information regarding your FreeStyle Libre 14 day system, including MRI contraindications, insulin contraindications, and sensor removal ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf16/P160030S017B.pdf

summary of safety and effectiveness data (ssed) The warnings and precautions can be found in the Freestyle Libre 14 Day Flash Glucose. Monitoring System labeling. V. DEVICE DESCRIPTION. The ...

8. freestyle.abbott freestyle.abbott/us-en/products/freestyle-libre-2.html

FreeStyle Libre 2 System | FreeStyle Libre US Know your glucose level and where it is headed with the FreeStyle Libre 2 system. See full information about FreeStyle Libre 2 and if you qualify for a free ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5898159/

Freestyle Libre Glucose Monitoring System - PMC The FDA has identified inaccuracies of the system at lower glucose levels, as seen in the clinical trials of the system. In 40% of instances in which the device ...

10. freestyleserver.com freestyleserver.com/Payloads/IFU/2023/q4/DOC48621_rev_A/English/Assets/mi_important_safety_information.html

FS-Libre-US: Important Information Important Safety Information. You can use the FreeStyle Libre 2 System with either the FreeStyle Libre 2 Sensor or the FreeStyle Libre 2 Plus Sensor.