Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Other
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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
  • Device: FreeStyle Libre System plus food app
    FreeStyle Libre Flash Glucose Monitoring System and Smartphone Food Logging application
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

Recruiting Locations

Boston Medical Center
Boston, Massachusetts 02118
Contact:
Devin SteenKamp, MD
617-638-7470
desteenk@bu.edu

More Details

Status
Recruiting
Sponsor
Abbott Diabetes Care

Study Contact

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.