We R the Cure

Seeking Cures and Cheating Destiny

New Artificial Pancreas Trial: Crossover Feasibility Study of Portable AP Device With Zone-MPC and HMS and Adapted I:C and Basal Insulin (DP3)

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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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01929798

Contacts: Howard C Zisser, MD;

805-682-7640 ext 255

hzisser@sansum.org

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Author: werthecure01

Diabetes doesn't define me; it inspires me to define the future for individuals living with autoimmune diseases like Type 1 diabetes. -- Mike Anderson, diagnosed 1998.

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