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| Name | Class |
|---|---|
| Harvard University | OTHER |
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This clinical trial is a safety and feasibility study to assess the performance of artificial pancreas (AP) system using the Zone Model Predictive control (Zone-MPC) and Health Monitoring System (HMS) algorithms embedded into the APS APP platform.
The system will be evaluated on up to 10 adult subjects with type 1 diabetes age 18-75 years old at a single clinical site (Sansum Diabetes Research Institute), who will complete a 48-hour closed-loop (CL) session in an observed CRC environment with medical staff present. During the session subjects will bolus for all meals and snacks and perform a 45-minute walking session while supervised by medical staff. The AP system used consists of an insulin pump, a CGM sensor, and a phone app (the Artificial Pancreas System [APS] phone app).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Artificial Pancreas App | Experimental | After completing a 1 week open-loop run in period, subjects will use the APS APP for a 48-hour period in an observed transitional environment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Artificial Pancreas App | Device | The portable Artificial Pancreas System App (APS APP) is an artificial pancreas system comprised primarily of an insulin pump, a continuous glucose monitor (CGM), and a cellular phone device to connect the components. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent time in glucose range 70-180 mg/dL | Time in target glucose range overall | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Percent time in glucose range 80-140 mg/dL overnight | Overnight time in tight target range | 48 hours |
| Percent time in glucose range 70-150 mg/dl postprandial within 5 hours following meals | Post prandial time in target |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eyal Dassau, PhD | Harvard University | Principal Investigator |
| Jordan Pinsker, MD | Sansum Diabetes Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sansum Diabetes Research Institute | Santa Barbara | California | 93105 | United States |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D006943 | Hyperglycemia |
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| 48 hours |
| Percent time glucose < 70 mg/dL | Hypoglycemia | 48 hours |
| Percent time glucose < 54 mg/dL | Significant Hypoglycemia | 48 hours |
| Percent time glucose > 180 mg/dL | Hyperglycemia | 48 hours |
| Percent time glucose > 250 mg/dL | Significant Hyperglycemia | 48 Hours |
| Connectivity Analysis (Number of Connection Errors Between devices) | Failure analysis of the devices/connectivity issues that may occur. This includes the overall number of connectivity errors between pump, sensor and phone device and the types of errors and how they were addressed. | 48 Hours |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |