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| Name | Class |
|---|---|
| University of Virginia | OTHER |
| Mayo Clinic | OTHER |
| University of California, Santa Barbara | OTHER |
| University of Padova |
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The purpose of this trial is to assess the performance of an Artificial Pancreas (AP) device using the Portable Artificial Pancreas System (pAPS) platform for subjects with type 1 diabetes using an insulin pump and rapid acting insulin. This proposed study is designed to compare closed-loop control with or without optimization of initialization parameters related to basal insulin infusion rates and insulin to carbohydrate (I:C) ratios for meals and snacks.
The study consists of an evaluation of the Artificial Pancreas device system during two 24-27.5-hour closed-loop phases in an outpatient/hotel environment. Prior to the closed-loop phases, each subject will undergo a 7-day data collection period consisting of his or her usual free-living conditions along with 3 meals of known carbohydrate content. Data from the insulin pump, a continuous glucose monitoring sensor (CGM), diet and exercise records will be collected during this period. These data from this 7-day period will be analyzed in order to come up with adapted basal insulin infusion rates and bolus insulin to carbohydrate (I:C) ratios.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Optimized basal/bolus with artificial pancreas | Experimental | Portable artificial pancreas with optimization |
|
| Nominal basal/bolus treatment | No Intervention | Portable artificial pancreas without optimization. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| portable Artificial Pancreas | Device | The artificial pancreas system will be allowed to employ its Model Predictive Control algorithm to make decisions about insulin delivery based on measured glucose levels. |
| Measure | Description | Time Frame |
|---|---|---|
| time spent in safe blood glucose range | The percentage time spent in safe blood glucose range of [80-140] mg/dl will be the primary endpoint. More time spent inside the desired range will be considered successful. Expected levels are [70-180] mg/dl the 5 hours after meals and [70-150] mg/dl 3 hours after exercise. | 24-hour closed-loop |
| Measure | Description | Time Frame |
|---|---|---|
| glucose level extremes and need for outside intervention | The secondary endpoint measures glucose extremes and the need for outside intervention to prevent hypoglycemia or hyperglycemia. Interventions would be insulin injections or oral carbohydrates given to the subject by the physician. No need for physician intervention will be considered a successful outcome. | 24-hour closed loop |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sansum Diabetes Research Institutute | Santa Barbara | California | 93105 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26204135 | Result | Dassau E, Brown SA, Basu A, Pinsker JE, Kudva YC, Gondhalekar R, Patek S, Lv D, Schiavon M, Lee JB, Dalla Man C, Hinshaw L, Castorino K, Mallad A, Dadlani V, McCrady-Spitzer SK, McElwee-Malloy M, Wakeman CA, Bevier WC, Bradley PK, Kovatchev B, Cobelli C, Zisser HC, Doyle FJ 3rd. Adjustment of Open-Loop Settings to Improve Closed-Loop Results in Type 1 Diabetes: A Multicenter Randomized Trial. J Clin Endocrinol Metab. 2015 Oct;100(10):3878-86. doi: 10.1210/jc.2015-2081. Epub 2015 Jul 23. |
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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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| OTHER |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |