Evaluation of Flash Continuous Glucose Monitoring to Reduce Hyperglycemia in People With T2 Diabetes
NCT ID: NCT04843527
Last Updated: 2025-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
350 participants
INTERVENTIONAL
2021-04-02
2025-06-30
Brief Summary
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Detailed Description
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The subsequent impact on reducing the amount of time spent above 180 mg/dL will be assessed.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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FreeStyle Libre
Subjects will be randomized to use the FreeStyle Libre Flash Glucose Monitoring System to manage their diabetes.
FreeStyle Libre System
FreeStyle Libre Flash Glucose Monitoring System
FreeStyle Libre plus food logging
Subjects will be randomized to use the FreeStyle Libre Flash Glucose Monitoring System and a food logging smartphone application to manage their diabetes.
FreeStyle Libre System plus food app
FreeStyle Libre Flash Glucose Monitoring System and Smartphone Food Logging application
Interventions
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FreeStyle Libre System
FreeStyle Libre Flash Glucose Monitoring System
FreeStyle Libre System plus food app
FreeStyle Libre Flash Glucose Monitoring System and Smartphone Food Logging application
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
ALL
No
Sponsors
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Abbott Diabetes Care
INDUSTRY
Responsible Party
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Principal Investigators
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Shridhara A Karinka, PhD
Role: STUDY_DIRECTOR
Abbott Diabetes Care Inc
Locations
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Boston Medical Center
Boston, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
HealthPartners Institute dba International Diabetes Center
Minneapolis, Minnesota, United States
UMPC
Pittsburgh, Pennsylvania, United States
Countries
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Other Identifiers
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ADC-US-RES-19185
Identifier Type: -
Identifier Source: org_study_id
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