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Evaluation of Flash Continuous Glucose Monitoring to Reduce Hyperglycemia in People With T2 Diabetes

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ClinicalTrials.gov Identifier: NCT04843527
Recruitment Status : Recruiting
First Posted : April 13, 2021
Last Update Posted : March 9, 2022
Sponsor:
Information provided by (Responsible Party):
Abbott Diabetes Care

Study Description
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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 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Device: FreeStyle Libre System Device: FreeStyle Libre System plus food app Not Applicable

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 Monitoring System or FreeStyle Libre Flash Glucose Monitoring System with a food logging smartphone application to manage their diabetes.

The subsequent impact on reducing the amount of time spent above 180 mg/dL will be assessed.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluation of Flash Continuous Glucose Monitoring to Reduce Hyperglycemia in People
Actual Study Start Date : April 2, 2021
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hyperglycemia

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: FreeStyle Libre
Subjects will be randomized to use the FreeStyle Libre Flash Glucose Monitoring System to manage their diabetes.
 Device: FreeStyle Libre System
FreeStyle Libre Flash Glucose Monitoring System
Active Comparator: 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.
 Device: FreeStyle Libre System plus food app
FreeStyle Libre Flash Glucose Monitoring System and Smartphone Food Logging application


Outcome Measures
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Primary Outcome Measures :
  1. Impact on time above 180 mg/dL [ Time Frame: Three (3) months ]
    To assess the impact of the FreeStyle Libre Flash Glucose Monitoring System with and with food logging app on time above 180 mg/dL


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04843527


Locations
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United States, Minnesota
HealthPartners Institute dba International Diabetes Center Recruiting
Minneapolis, Minnesota, United States, 55416
Contact: Thomas Martens, MD    952-993-4865    Thomas.martens@parknicollet.com   
Sponsors and Collaborators
Abbott Diabetes Care
Investigators
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Study Director: Shridhara A Karinka, PhD Abbott Diabetes Care, Inc.
More Information
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Responsible Party: Abbott Diabetes Care
ClinicalTrials.gov Identifier: NCT04843527    
Other Study ID Numbers: ADC-US-RES-19185
First Posted: April 13, 2021    Key Record Dates
Last Update Posted: March 9, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Hyperglycemia
Diabetes Mellitus
 Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases