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A multi-center, randomized, prospective, non-significant risk study to compare the impact of the FreeStyle Libre 2 Flash Glucose Monitoring System to the current standard of care (SMBG, self-monitoring of blood glucose) 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.
Up to approximately 350 subjects will be enrolled to obtain a minimum of 130 randomized subjects, with a minimum of approximately 65 subjects per arm. At least 50% of randomized subjects will be age 65 and older. Subjects will be randomized to use either the FreeStyle Libre 2 Flash Glucose Monitoring System or traditional SMBG to manage their diabetes. The subsequent impact of FreeStyle Libre 2 versus SMBG on reducing the amount of time spent above 180 mg/dL will be assessed.
Safety of the FreeStyle Libre 2 Flash Glucose Monitoring System and SMBG will be characterized by Adverse Device Effects and Serious Adverse Device Effects experienced by study participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SMBG, self-monitoring of blood glucose | Subjects will be randomized to continue use traditional SMBG, self-monitoring of blood glucose, to manage their diabetes. |
| |
| FreeStyle Libre 2 | Subjects will be randomized to use the FreeStyle Libre 2 Flash Glucose Monitoring System to manage their diabetes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SMBG Meter | Device | Self Monitoring Blood Glucose Meter |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Impact on time above 180 mg/dL in subjects with type 2 diabetes | To assess the impact of the FreeStyle Libre 2 Flash Glucose Monitoring System on time above 180 mg/dL in subjects with type 2 diabetes who are not adequately controlled on their existing oral anti-diabetes medication regimen when compared to the current standard of care (SMBG, self-monitoring of blood glucose). | Six (6) months |
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Inclusion Criteria:
Exclusion Criteria:
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Adult subjects with type 2 diabetes diagnosis currently on oral anti-diabetes medication(s).
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| Name | Affiliation | Role |
|---|---|---|
| Shridhara A Karinka, PhD | Abbott Diabetes Care Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Valley Research | Fresno | California | 93720 | United States | ||
| CEDE (Center of Excellence in Diabetes and Endocrinology) |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| FreeStyle Libre 2 System |
| Device |
The Abbott's FreeStyle Libre 2 Flash Glucose Monitoring System |
|
| Sacramento |
| California |
| 95821 |
| United States |
| Metabolic Research Institute | West Palm Beach | Florida | 33401 | United States |
| Billings Clinic | Billings | Montana | 59101 | United States |
| Palm Research Center | Las Vegas | Nevada | 89148 | United States |