Introduction: Intensive care unit (ICU) patients develop stress induced insulin resistance causing hyperglycemia, large glucose variability and hypoglycemia, all of which increase mortality rates. Tight glucose control (TGC) in the ICU is challenging, and usually significantly increases the risk for treatment induced hypoglycemia. The only way to achieve safe TGC will be through use of an artificial pancreas (AP) system. Our goal with the present study was to assess the safety and performance of an AP system, composed of the EIRUS (Getinge AB) continuous glucose monitor (CGM) and novel artificial intelligence-based (AI-based) glucose control software, in a swine model using unannounced hypo- and hyperglycemia challenges.

Methods: Fourteen piglets (6 control, 8 treated) underwent sequential unannounced (to the AP system) hypoglycemic and hyperglycemic challenges with 3 U of insulin aspart and a large glucose infusion over the course of 5 hours. In the control animals an ICU physician used every 30-minute arterial blood glucose values to maintain control to a range of 4.4 - 9 mmol/L through use of 20% dextrose for hypoglycemia and insulin aspart for hyperglycemia. In the treated group the AP system attempted to maintain blood glucose control to a range of 4.4 - 6.6 mmol/L in a fully autonomous mode.

Results: Five of six control animals and none of eight treated animals experienced severe hypoglycemia (< 2.22 mmol/L). The area under the curve 3.5 mmol/L was 28.9 (21.1 - 54.2) for control and 4.8 (3.1 - 5.2) for the treated animals. The percent time in range 4.4 - 6.6 mmol/L was 32.8 (32.4 - 47.1) for the control and 55.4 (52.9 - 59.4) for the treated animals. After the start of the experiment the control animals underwent 4 (3-5) human interventions to maintain control whereas the treated animals underwent none. Data are median (25-75).

Conclusions The AP system abolished severe hypoglycemia and outperformed the ICU physician both in avoiding hypoglycemic excursions and maximizing time in range.


J. DeJournett: Employee; Self; Ideal Medical Technologies. L. DeJournett: Stock/Shareholder; Self; Ideal Medical Technologies.

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