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This is a prospective, multi-center, non-randomized, single-arm, post-approval study of the FreeStyle Libre Flash Glucose Monitoring System intended to characterize the safety of the Libre Flash Glucose Monitoring System when used in people with diabetes.
Up to 920 adult subjects, aged 18 years and older with type 1 or type 2 diabetes, who require daily blood glucose monitoring to manage their diabetes, will be enrolled to obtain at least 736 subjects who complete the final visit. Subjects will utilize capillary SMBG for managing diabetes for 6 months (control phase) followed by diabetes management using FreeStyle Libre for 6 months (intervention phase). Subjects will maintain a diary/log book of Adverse Events during each phase. Assessment of Adverse Events will occur via self reporting at each monthly visit and/or phone call.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SMBG and FreeStyle Libre | During the intervention phase, subjects will use FreeStyle Libre Flash Glucose Monitoring System for 6 months to managed their diabetes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FreeStyle Libre Flash Glucose Monitoring System | Device | Subjects will utilize capillary SMBG for managing diabetes for 6 months (control phase) followed by diabetes management using FreeStyle Libre for 6 months (intervention phase). |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of the FreeStyle Libre Flash Glucose Monitoring System | The study is designed to characterize the safety of the FreeStyle Libre Flash Glucose Monitoring System when used in the intended study population. | Approximately one year per subject. |
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Inclusion Criteria:
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Adult subjects aged 18 years and older with type 1 or type 2 diabetes, who require daily blood glucose monitoring to manage their diabetes. At least 20% of the study population will be age 30 or below and 15% will be age 65 or older.
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| Name | Affiliation | Role |
|---|---|---|
| Shridhara A Karinka, PhD | Abbott Diabetes Care Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sansum Diabetes Research Institute | Santa Barbara | California | 93105 | United States | ||
| Baptist Diabetes Associates, P.A |
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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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| Miami |
| Florida |
| 33156 |
| United States |
| Metabolic Research Institute | West Palm Beach | Florida | 33401 | United States |
| Rocky Mountain Diabetes & Osteoporosis Center | Idaho Falls | Idaho | 83404 | United States |
| Iowa Diabetes & Endocrinology Research Center | Des Moines | Iowa | 50265 | United States |
| MassResearch, LLC | Waltham | Massachusetts | 02453 | United States |
| Henry Ford Medical Center | Detroit | Michigan | 48202 | United States |
| Albuquerque Neuroscience Inc. | Albuquerque | New Mexico | 87109 | United States |
| Texas Diabetes & Endocrinology | Round Rock | Texas | 78681 | United States |
| Clinical Trials of Texas | San Antonio | Texas | 78229 | United States |