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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FreeStyle Libre | Active Comparator | Subjects will be randomized to use the FreeStyle Libre Flash Glucose Monitoring System to manage their diabetes. |
|
| FreeStyle Libre plus food logging | Active Comparator | Subjects will be randomized to use the FreeStyle Libre Flash Glucose Monitoring System and a food logging smartphone application to manage their diabetes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FreeStyle Libre System | Device | FreeStyle Libre Flash Glucose Monitoring System |
| |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shridhara A Karinka, PhD | Abbott Diabetes Care Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Medical Center | Boston | Massachusetts | 02118 | United States | ||
| Henry Ford Health System |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39757879 | Derived | Martens TW, Willis HJ, Bergenstal RM, Kruger DF, Karslioglu-French E, Steenkamp DW. A Randomized Controlled Trial Using Continuous Glucose Monitoring to Guide Food Choices and Diabetes Self-Care in People with Type 2 Diabetes not Taking Insulin. Diabetes Technol Ther. 2025 Apr;27(4):261-270. doi: 10.1089/dia.2024.0579. Epub 2025 Jan 6. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| FreeStyle Libre System plus food app |
| Device |
FreeStyle Libre Flash Glucose Monitoring System and Smartphone Food Logging application |
|
| Detroit |
| Michigan |
| 48202 |
| United States |
| HealthPartners Institute dba International Diabetes Center | Minneapolis | Minnesota | 55416 | United States |
| UMPC | Pittsburgh | Pennsylvania | 15213 | United States |
| D004700 | Endocrine System Diseases |