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This is an outpatient study testing different starting doses of insulin in participants with type 2 diabetes. Participants will manage their diabetes using the Omnipod M System. The system is comprised of an Omnipod M Pod, an Omnipod M Controller, and will be used with a Dexcom G6 continuous glucose monitoring sensor (CGM). The main objectives of the study are to evaluate the safety and tolerability of different starting doses of insulin using the Omnipod M System.
There is a precursory evaluation before the main, randomized trial. Participation in the precursory evaluation could last up to 12 weeks and participation in the randomized trial could last up to 6 weeks. During both the evaluation and the randomized trial, participants will manage their diabetes using the Omnipod M System in Automated Mode.
An optional 12-weeks of continued Omnipod M System use is available upon completion of the randomized trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omnipod M System with lower starting dose | Active Comparator |
| |
| Omnipod M System with higher starting dose | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Comparator: Omnipod M System with lower starting dose | Device | Omnipod M Automated Insulin Delivery System with Dexcom G6 continuous glucose monitoring system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of time >180 mg/dL | Glucose metric from study continuous glucose monitoring system | Comparing baseline to days 7, 14, 21, and 28 and end of continuation phase in the randomized trial. |
| Percent of time <70 mg/dL | Glucose metric from study continuous glucose monitoring system | Comparing baseline to days 7, 14, 21, and 28 and end of continuation phase in the randomized trial. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of time in range (TIR) 70-180 mg/dL | Glucose metric from study continuous glucose monitoring system | Comparing baseline to days 7, 14, 21, and 28 and end of continuation phase in the randomized trial. |
| Percent of time above range (TAR) >250 mg/dL |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado | Aurora | Colorado | 80045 | United States | ||
| Emory University |
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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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| Active Comparator: Omnipod M System with higher starting dose | Device | Omnipod M Automated Insulin Delivery System with Dexcom G6 continuous glucose monitoring system |
|
Glucose metric from study continuous glucose monitoring system |
| Comparing baseline to days 7, 14, 21, and 28 and end of continuation phase in the randomized trial. |
| Percent of time below range (TBR) <54 mg/dL | Glucose metric from study continuous glucose monitoring system | Comparing baseline to days 7, 14, 21, and 28 and end of continuation phase in the randomized trial. |
| Total daily insulin (TDI) | Glucose metric from study continuous glucose monitoring system | Comparing baseline to days 7, 14, 21, and 28 and end of continuation phase in the randomized trial. |
| Total daily insulin/kg | Glucose metric from study continuous glucose monitoring system | Comparing baseline to days 7, 14, 21, and 28 and end of continuation phase in the randomized trial. |
| Perception questionnaire | Includes questions about participant's private attitudes, feelings, and behavior related to the investigational device as well as managing diabetes. | Comparing baseline to days 7, 14, 21, and 28 and end of continuation phase in the randomized trial. |
| Weight | Measures change in weight | Comparing baseline to end of continuation phase in the randomized trial. |
| HbA1c | Measures changes in HbA1c | Comparing baseline to end of continuation phase in the randomized trial. |
| Atlanta |
| Georgia |
| 30303 |
| United States |
| Joslin Diabetes Center | Boston | Massachusetts | 02215 | United States |
| MassResearch LLC. | Waltham | Massachusetts | 02453 | United States |
| AccellaCare | Wilmington | North Carolina | 28401 | United States |
| Disease & Glandular Disease Clinic | San Antonio | Texas | 78229 | United States |
| D004700 | Endocrine System Diseases |