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This is a single arm feasibility study to evaluate the Omnipod M System in adults with Type 2 Diabetes with the aim to enroll to 40 participants aged 18-75 years with type 2 diabetes to have a minimum of 20 participants initiate the use of Omnipod M System and the goal of 16 participants completing the 6-week treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental- Participants with Type 2 diabetes | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omnipod M system | Device | The Omnipod M system will allow user to use a lower glucose target and improve systems glucose control |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of time in hypoglycemic range <70mg/dL | Glucose metric from study continuous glucose monitoring system | Comparing baseline metrics to the end of the treatment period (Day45) |
| Percent of time in hyperglycemic range >180 mg/dL | Glucose metric from study continuous glucose monitoring system | Comparing baseline metrics to the end of the treatment period (Day45) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Glucose | Glucose metric from study continuous glucose monitoring system | Comparing baseline metrics to the end of the treatment period (Day45) |
| Percentage of time <54 mg/dL | Glucose metric from study continuous glucose monitoring system |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Joslin Diabetes | Boston | Massachusetts | 02215 | United States | ||
| MassResearch LLC. |
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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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| Comparing baseline metrics to the end of the treatment period (Day45) |
| Percentage of time >250mg/dL | Glucose metric from study continuous glucose monitoring system | Comparing baseline metrics to the end of the treatment period (Day45) |
| Percentage of time >300mg/dL | Glucose metric from study continuous glucose monitoring system | Comparing baseline metrics to the end of the treatment period (Day45) |
| Percent of time between 70-180mg/dL | Glucose metric from study continuous glucose monitoring system | Comparing baseline metrics to the end of the treatment period (Day45) |
| Standard Deviation | Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the standard deviation (SD) | Comparing baseline metrics to the end of the treatment period (Day45) |
| Coefficient of Variation | Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the coefficient of variation (CV) | Comparing baseline metrics to the end of the treatment period (Day45) |
| Average total daily insulin (TDI) | Glucose metric from study continuous glucose monitoring system | Comparing baseline metrics to the end of the treatment period (Day45) |
| Average TDI/kg | Glucose metric from study continuous glucose monitoring system | Comparing baseline metrics to the end of the treatment period (Day45) |
| Change in weight | measures change in weight | Comparing baseline metrics to the end of the treatment period (Day45) |
| Patient reported outcomes | Participant responses to various questionnaires related to the investigational device as well as managing diabetes | Comparing baseline metrics to the end of the treatment period (Day45) |
| 4-hour post prandial glycemic metrics | Glucose metric from study continuous glucose monitoring system | Comparing baseline metrics to the end of the treatment period (Day45) |
| Waltham |
| Massachusetts |
| 02453 |
| United States |
| Henry Ford Health | Detroit | Michigan | 48202 | United States |
| Mountain Area Health Educational Center ( MAHEC) | Asheville | North Carolina | 28803 | United States |
| Texas Diabetes and Endocrinology (TDE) | Austin | Texas | 78731 | United States |
| Disease & Glandular Disease Clinic | San Antonio | Texas | 78229 | United States |
| D004700 | Endocrine System Diseases |