Diabetes Mellitus, Type 2
Conditions
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.
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.
Interventions
DEVICEFreeStyle Libre System
FreeStyle Libre Flash Glucose Monitoring System
DEVICEFreeStyle Libre System plus food app
FreeStyle Libre Flash Glucose Monitoring System and Smartphone Food Logging application
Sponsors
Abbott Diabetes Care
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Impact on time above 180 mg/dL | 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 |
Countries
United States
Outcome results
None listed