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This is a non-blinded, prospective, multi-center, single arm longitudinal cohort study (patient serving as their own control), to evaluate the effectiveness of diabetes with the Eversense CGM System non-adjunctively compared to self-monitoring of blood glucose (SMBG) using a blood glucose (BG) meter in participants with either Type 1 or Type 2 diabetes. Subjects will serve as their own control, with their baseline based on using SMBG to manage their diabetes for the first 6 months followed by using Eversense CGM System non-adjunctively for the second 6 months. Total follow-up duration is 12 months. The investigation will include both clinic visits and home use of Eversense CGM System. The nonadjunctive phase will have two sensors, up to 90-day duration, inserted sequentially. All care decisions specific to diabetes will be based on blood glucose (BG) values in the first phase and the Eversense CGM system values in the second phase.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self monitoring of blood glucose, then CGM System | Experimental | All participants will first manage their diabetes with SMBG for 6 months followed by managing their diabetes with Eversense CGM system for the next 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood glucose meter | Device | First phase: SMBG for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of moderate and severe hypoglycemic and diabetic ketoacidosis events | Incidence of moderate and severe hypoglycemic and diabetic ketoacidosis events with SMBG use for 6 months compared to Eversense CGM system used non-adjunctively for 6 months | First 6 months (phase 1) compared to second 6 months (phase 2) |
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Inclusion Criteria:
Exclusion Criteria:
Subject is critically ill or hospitalized
Prior use of CGM defined as:
Subject has a known contraindication to dexamethasone or dexamethasone acetate
Subjects requiring intravenous mannitol or mannitol irrigation solutions
Subject is on dialysis at the time of enrollment
Female subjects who are pregnant, planning on becoming pregnant or nursing
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LA Universal Research Center, Inc. | Los Angeles | California | 90057 | United States | ||
| Denver Endocrinology, Diabetes & Thyroid Center |
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| Eversense CGM System | Device | Second phase: CGM for 6 months |
|
| Englewood |
| Colorado |
| 80113 |
| United States |
| CMR of Greater New Haven | Hamden | Connecticut | 06517 | United States |
| Chase Medical Research | Waterbury | Connecticut | 06708 | United States |
| The Center for Diabetes and Endocrine Care | Fort Lauderdale | Florida | 33312 | United States |
| MedCare Research | Miami | Florida | 33165 | United States |
| Miami Lakes Clinical Trials INC | Miami Lakes | Florida | 33014 | United States |
| Atlanta Diabetes Associates | Atlanta | Georgia | 30318 | United States |
| Rocky Mountain Clinical Research | Idaho Falls | Idaho | 83404 | United States |
| Springfield Clinic | Springfield | Illinois | 62702 | United States |
| Tandem Clinical Research | Marrero | Louisiana | 70072 | United States |
| Southern Maryland Medical Group | Camp Springs | Maryland | 20746 | United States |
| Metro Detroit Endocrinology | Dearborn | Michigan | 48126 | United States |
| Diabetes and Endocinology Specialists, Inc. | Chesterfield | Missouri | 63017 | United States |
| Endocrine Associates of West Village | Long Island City | New York | 11101 | United States |
| Physician's East Endocrinology | Greenville | North Carolina | 27834 | United States |
| Superior Clinical Research | Smithfield | North Carolina | 27577 | United States |
| AM Diabetes & Endocrinology | Bartlett | Tennessee | 38133 | United States |
| Texas Diabetes and Endocrinology | Austin | Texas | 78749 | United States |
| Southwest Family Medicine Associates | Dallas | Texas | 75235 | United States |
| Clinical Research Solution Institute | Houston | Texas | 77095 | United States |
| RGV Endocrine Center | McAllen | Texas | 78503 | United States |
| Green Mountain Research Institute | Rutland | Vermont | 05701 | United States |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003922 | Diabetes Mellitus, Type 1 |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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