Closed-loop subcutaneous insulin infusion algorithm with a short-acting insuin analog for long-term clinical application of a wearable artificial endocrine pancreas.

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Considering the management and safety of the insulin delivery route when a wearable artificial endocrine pancreas is applied to ambulatory diabetic patients for long-term basis, we developed a subcutaneous insulin infusion algorithm by analyzing the dynamics of subcutaneously injected short-acting insulin analogue (Insulin Lispro) by a three-compartmental model. Principally, the insulin infusion algorithm was developed as a transfer function with the first order delay in both proportional and derivative actions to blood glucose concentrations. The parameters for this algorithm were calculated to simulate a physiological plasma insulin profile as possible.By applying this algorithm with regular insulin, diabetic patients showed a 2-hr postprandial hyperglycemia and a delayd hyperinsulinemia, folowed by hypoglycemic episodes during 4 to 5 hr after oral glucose load, just as obervrd in computer simulation study. However using Insulin Lispro, a near-physiological glycemic control (postprandial blood glucose of 153.1(]SY.+-。[)8.3 mg/100 ml at 60 min, and 90.3(]SY.+-。[)7.1 mg/100 ml at 180 min, respectively) could be achieved without showing any delayd hyperinsulinemia nor hypoglycemia. Daily glycemic excursions were also controlled near-physiolosically and though the daily insulin requirement (731.7(]SY.+-。[)160.5 mU/kg/day) was slightly higher, but not significantly different from that with intravenous insulin infusion (622.3(]SY.+-。[)142.6 mU/kg/day).These results indicate that the application of the subcutaneous insulin infusion algorithm with Insulin Lispro is feasible for long-term glycemic control with the wearable artificial endocrine pancreas in ambulatory diabetic patients.