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| Name | Class |
|---|---|
| Boston University | OTHER |
| Massachusetts General Hospital | OTHER |
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This is an open-label, non-randomized, pilot study to determine the safety and feasibility of the insulin-only bionic pancreas.
A total of 16 subjects, ages 18-45, will be enrolled in this crossover study. The study will consist of three 7-day study arms in the following order, one usual care arm, one bionic pancreas insulin only arm with a static glucose target, and one bionic pancreas insulin only arm with at dynamic glucose target.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blinded Sensor | No Intervention | Subjects will wear a blinded Dexcom G4P (Generation 4 Platinum) AP (Artificial Pancreas) glucose sensor for a week | |
| Fixed set point | Experimental | Subjects will be in a hotel and use a fixed set point for glucose control for two days initialized at 130 mg/dl. The setpoint will be adjusted, if necessary, over the two days in the hotel before they are sent home for 5 days |
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| Variable Set Point | Experimental | Subjects will begin using a "variable" setpoint which will make adjustments based on their past glucose control over the previous day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fixed set point | Device | Fixed set point arm: A fixed setpoint will be used initially. Staff will observe glucose control over 2 days while subjects remain in a hotel environment, and then over 5 more days in the same subjects in an outpatient setting. The clinical staff will adjust this target up or down by 15 mg/dl based on their glycemic control in the hotel setting. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean glucose | Dexcom G4P AP mean glucose | change over 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| % time <50 mg/dl | Fraction of Dexcom G4P AP readings <60 mg/dl | change over 5 days |
| % time <70 mg/dl | Fraction of Dexcom G4P AP readings <70 mg/dl |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bruce A Buckingham, MD | Stanford School of Medicine, Pediatric Endocrinology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
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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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| Variable set point | Device | Variable set point arm: The setpoint will be variable over a 30 mg/dl range and glycemic control will be optimized based on the preceding 24-hour window. |
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| change over 5 days |
| % time 70-120 mg/dl | Fraction of Dexcom G4P AP readings 70-120 mg/dl | change over 5 days |
| % time 70-180 mg/dl | Fraction of Dexcom G4P AP readings 70-180 mg/dl | change over 5 days |
| % time >180 mg/dl | Fraction of Dexcom G4P AP readings >180 mg/dl | change over 5 days |
| % time >250 mg/dl | Fraction of Dexcom G4P AP readings >250 mg/dl | change over 5 days |
| % time < 60 mg/dl | Fraction of Dexcom G4AP readings < 60 mg/dl | Change over 5 days |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |