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

Study Overview
=================
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.

Official Title
-----------------
Evaluation of Flash Continuous Glucose Monitoring to Reduce Hyperglycemia in People

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Device: FreeStyle Libre System
* Device: FreeStyle Libre System plus food app


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: FreeStyle Libre<br>Subjects will be randomized to use the FreeStyle Libre Flash Glucose Monitoring System to manage their diabetes. | Device: FreeStyle Libre System<br>* FreeStyle Libre Flash Glucose Monitoring System<br>|
| Active Comparator: FreeStyle Libre plus food logging<br>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<br>* FreeStyle Libre Flash Glucose Monitoring System and Smartphone Food Logging application<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact on time above 180 mg/dL | To assess the impact of the FreeStyle Libre Flash Glucose Monitoring System with and with food logging app on time above 180 mg/dL | Three (3) months |