Evaluation of Flash Continuous Glucose Monitoring to Reduce Hyperglycemia in People With T2 Diabetes
NCT04843527 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 350
Last updated 2025-01-30
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 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.
Conditions
- Diabetes Mellitus, Type 2
Interventions
- DEVICE
-
FreeStyle Libre System
FreeStyle Libre Flash Glucose Monitoring System
- DEVICE
-
FreeStyle Libre System plus food app
FreeStyle Libre Flash Glucose Monitoring System and Smartphone Food Logging application
Sponsors & Collaborators
-
Abbott Diabetes Care
lead INDUSTRY
Principal Investigators
-
Shridhara A Karinka, PhD · Abbott Diabetes Care Inc
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-04-02
- Primary Completion
- 2025-06-30
- Completion
- 2025-06-30
- FDA Device
- Yes
Countries
- United States
Study Locations
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