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To assess the safety and performance of the Insulet AP (artificial pancreas) system, using the Omnipod® insulin management system, Dexcom G4 Share® AP System and personalized model predictive control algorithm in adults with type 1 diabetes consuming high fat meals and undertaking moderate intensity exercise.
The two-part study schedule consists of a 7±1 day outpatient, open-loop phase, followed by one 54-hour, hybrid closed-loop phases conducted in a supervised CRC or hotel/rental house setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meal Performance and/or Exercise | Other | This study is a two-part, multi-center, observational clinical trial being conducted in a Clinical Research Center (CRC) setting using the Insulet AP (artificial pancreas) system. Subjects may participate in hybrid closed-loop session Option A - Meal Performance and/or Option B - Exercise, but are not required to participate in both. If participating in both, Option A and Option B must be conducted in separate sessions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulet AP (artificial pancreas) System | Device | Insulet AP (artificial pancreas) system, using the Omnipod® insulin management system, Dexcom G4 Share® AP System and personalized model predictive control algorithm. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of time in hypoglycemic range (defined as < 70 mg/dL) | 54 hours | |
| Percentage of time in hyperglycemic range(defined as ≥ 250 mg/dL) | 54 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Mean glucose | 54 hours | |
| Percentage of time < 50 mg/dL | 54 hours | |
| Percentage of time < 60 mg/dL |
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Inclusion Criteria:
Exclusion Criteria:
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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 | ||
| Diablo Clinical Research |
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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 |
|---|---|
| D019397 | Pancreas, Artificial |
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D001187 | Artificial Organs |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
| D004358 | Drug Therapy |
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The two-part study schedule consists of a 7±1 day outpatient, open-loop phase, followed by one 54-hour (Option A - Meal Performance and/or Option B - Exercise), hybrid closed-loop phases conducted in a supervised CRC or hotel/rental house setting. Subjects may participate in hybrid closed-loop session Option A and/or Option B.
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| 54 hours |
| Percentage of time > 180 mg/dL | 54 hours |
| Percentage of time ≥ 300 mg/dL | 54 hours |
| Percentage of time between 70-180 mg/dL | 54 hours |
| Percentage of time between 70-140 mg/dL | 54 hours |
| Standard deviation | 54 hours |
| Coefficient of variation | 54 hours |
| Meal challenge-12 hour PPG dinner | The post-prandial glucose response including time to peak glucose, peak glucose concentration, and peak glucose excursion and the 12-hour post-prandial period following dinner. | 54 hours |
| Meal challenge-4 hour PPG breakfast | The post-prandial glucose response including time to peak glucose, peak glucose concentration, and peak glucose excursion for the 4-hour post-prandial period following breakfast. | 54 hours |
| Meal challenge-4 hour PPG lunch | The post-prandial glucose response including time to peak glucose, peak glucose concentration, and peak glucose excursion for the 4-hour post-prandial period following lunch. | 54 hour |
| Exercise challenge-immediate and delayed glucose response | The immediate (2 hours) and delayed (24 hours) glucose response to moderate intensity exercise. | 54 hour |
| Effect of changing setpoints | Effect of changing setpoints to overall performance. | 54 hour |
| 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 |
| D013812 |
| Therapeutics |