Status:
ACTIVE_NOT_RECRUITING
Evaluation of Flash Continuous Glucose Monitoring to Reduce Hyperglycemia in People With T2 Diabetes
Lead Sponsor:
Abbott Diabetes Care
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
Detailed Description
Approximately 350 subjects will be enrolled to obtain at least 84 randomized subjects,approximately 42 subjects per arm. Subjects will be randomized to use either the FreeStyle Libre Flash Glucose Mon...
Eligibility Criteria
Inclusion
- Subject must be at least 18 years of age.
- Subject has been diagnosed with type 2 diabetes.
- HbA1c greater than or equal to 7.5% and less than or equal to 12%
- Subject is on at least 1 diabetes medication in the classes of metformin, SGLT-2 inhibitors, GLP-1 agonists and DPP-4 inhibitors.
- Subject owns a compatible smartphone
- Subject agrees to a 3-month period of no diabetes medication changes.
- Subject is willing to make diet and lifestyle changes in response to education and glucose data
Exclusion
- Subject is currently on insulin therapy or sulfonylurea-based medications.
- 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).
- Subject has extensive skin changes/diseases at the proposed application sites that could interfere with device placement or the accuracy of interstitial glucose measurements.
Key Trial Info
Start Date :
April 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT04843527
Start Date
April 2 2021
End Date
June 1 2025
Last Update
January 30 2025
Active Locations (4)
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1
Boston Medical Center
Boston, Massachusetts, United States, 02118
2
Henry Ford Health System
Detroit, Michigan, United States, 48202
3
HealthPartners Institute dba International Diabetes Center
Minneapolis, Minnesota, United States, 55416
4
UMPC
Pittsburgh, Pennsylvania, United States, 15213