1036-P: Closed-Loop Glucose Control System for In-Hospital Use: Extended Control Trials

Background: Optimal in-hospital glucose control is a requirement for reducing mortality, morbidity and duration of admission. Present glucose concentrations in critical care are characterized by marked variability and episodes of hypoglycemia due to inadequate sensing and treatment technologies. We have previously shown (ADA 2016), that a prototype closed loop system (Admetsys™) infusing insulin/dextrose is capable of controlling blood glucose.

Aim: The aim of this study was to assess the ability of the Admetsys™ Insulin Based Infusion Systems (IBIS) (totally closed loop system) to lower, stabilize and maintain desired glucose levels and to avoid episodes of hypoglycemia for an extended period of time of up to 24 hours in patients “during admission to hospital.”

Methodology: 12 people with diabetes (ten with type 1 diabetes, two with type 2 diabetes) ranging from 26-49 years of age were admitted to our clinical research unit. The duration of the study was up to 24 hours, and at beginning of the study blood glucose levels were betwee 150 and 300 mg/dl. Through a three-way connector the Admetsys™ IBIS was connected to insulin and glucose/dextrose pumps and linked to an intravenous automated glucose sensor (VIA Glucoscout), which sent the data to the treatment system. A saline solution was infused to insure vein patency. The therapeutic target range was set to 80-125 mg/dl.

Results: Results from all twelve subjects were collected and analyzed. Mean time to reach the normoglycemic target range (80-125 mg/dl) was 2.36 hours. When target range was achieved the mean blood glucose level was 107.0 mg/dl (SD 8.6 mg/dl). No incidence of hypoglycemia (<70 mg/dl) occurred during the course of the trial.

Conclusion: The Admetsys™ IBIS system proved accurate, safe and reliable in this study. However, further studies in greater patient populations are needed to validate the full performance of this closed loop system designed for hospital use.