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Pilot Study of Closed-Loop Glucose Control in People With Type 1 Diabetes (BPK004)
This study plans to link two existing technologies, the insulin pump and the continuous glucose monitor (CGM), to essentially develop an artificial pancreas, i.e., closed-loop. This will be done using two continuous glucose monitors (CGMs), a computer containing an investigational control algorithm that uses glucose information from the CGM to recommend insulin dosing, and an insulin pump. The purpose of this study is to test the ability of continuous glucose monitors together with an insulin pump and a mathematical formula to control blood sugar levels of people with type 1 diabetes. The Closed-Loop control algorithm will: 1. Suggest adequate insulin delivery for blood glucose control in steady state (overnight); 2. Cover adequately with an insulin bolus the pre-set carbohydrate content of a breakfast. If successful, this study will conceptually prove the feasibility of automated model-predictive closed-loop glucose control in T1DM.
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