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The FreeStyle Libre 3 Continuous Glucose Monitoring (FSL3) System is used to characterize the glycemic profiles of people with and without a prediabetes diagnosis.
This is a non-pivotal, non-randomized, multi-center, prospective, non-significant risk to evaluate the glycemic profiles of people with and without a prediabetes diagnosis using continuous glucose monitoring. Up to 2000 subjects will be enrolled in up to 20 sites. Approximately 50% of evaluable subjects will have a prediabetes diagnosis.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FreeStyle Libre 3 | Device | Abbott Sensor Based Glucose Monitoring System (FreeStyle Libre 3 System) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Characterize the glycemic profiles of people with and without a prediabetes diagnosis. | This is a data collection study. | up to 50 days |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects will be stratified into groups, including male and female sex, race, age and Body Mass Index. Approximately 25 evaluable subjects will be enrolled into each group.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| MOHAMED NADA, PhD | Contact | 5107495416 | adc.clinical@abbott.com |
| Name | Affiliation | Role |
|---|---|---|
| Shridhara Karinka, PhD | Abbott Diabetes Care | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diabetes and Obesity Care | Recruiting | Bend | Oregon | 97702 | United States |
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| ID | Term |
|---|---|
| D018149 | Glucose Intolerance |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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