FreeStyle Libre System for Type 2 Diabetes
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?
Is the FreeStyle Libre System safe for humans?
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
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants use the FreeStyle Libre Flash Glucose Monitoring System, with or without a food logging app, to manage their diabetes
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- FreeStyle Libre System
- FreeStyle Libre System plus food app
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