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The purpose is to perform an early investigation on the safety and performance of an Automated Glucose Control (AGC) algorithm using the OmniPod® Insulin Management System and gather clinical data that will be used to make improvements or modifications to the algorithm for subsequent studies in adults, adolescents and children with type 1 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Cohort in CRC | Experimental | This study is a single-arm, multi-center, observational clinical trial being conducted in a Clinical Research Center (CRC) setting. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulet Artificial Pancreas (AP) System | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of time in hypoglycemic range (defined as <70 mg/dL) | 36 hours | |
| Percentage of time in severe hyperglycemic range (defined as >/=250 mg/dL) | 36 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Mean glucose | 36 hours | |
| Percentage of time < 50 mg/dL | 36 hours | |
| Percentage of time < 60 mg/dL |
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Inclusion Criteria:
Subjects must meet all of the following criteria to be included in the study:
Exclusion Criteria:
Subjects who meet any of the following criteria will be excluded from the study:
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| Name | Affiliation | Role |
|---|---|---|
| Bruce Buckingham, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94305 | United States | ||
| William Sansum Diabetes Center |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| 36 hours |
| Percentage of time > 180 mg/dL | 36 hours |
| Percentage of time >/= 300 mg/dL | 36 hours |
| Percentage of time in the broad euglycemic range (defined as 70-180) mg/dL) | 36 hours |
| Percentage of time in the tight euglycemic range (defined as 70-140) mg/dL) | 36 hours |
| Standard deviation and coefficient of variation of CGM values | 36 hours |
| Santa Barbara |
| California |
| 93105 |
| United States |
| Diablo Clinical Research | Walnut Creek | California | 94598 | United States |
| University of Colorado Denver | Denver | Colorado | 80045 | United States |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |