Abstract
Intensive care unit (ICU) patients develop stress induced insulin resistance causing hyperglycemia, large glucose variability and hypoglycemia. These glucose metrics have all been associated with increased rates of morbidity and mortality. The only way to achieve safe glucose control at a lower glucose range (e.g., 4.4–6.6 mmol/L) will be through use of an autonomous closed loop glucose control system (artificial pancreas). Our goal with the present study was to assess the safety and performance of an artificial pancreas system, composed of the EIRUS (Maquet Critical Care AB) continuous glucose monitor (CGM) and novel artificial intelligence-based glucose control software, in a swine model using unannounced hypo- and hyperglycemia challenges. Fourteen piglets (6 control, 8 treated) underwent sequential unannounced hypoglycemic and hyperglycemic challenges with 3 IU of NovoRapid and a glucose infusion at 17 mg/kg/min over the course of 5 h. In the Control animals an experienced ICU physician used every 30-min blood glucose values to maintain control to a range of 4.4–9 mmol/L. In the Treated group the artificial pancreas system attempted to maintain blood glucose control to a range of 4.4–6.6 mmol/L. 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 total percent time within tight glucose control range, 4.4–6.6 mmol/L, was 32.8% (32.4–47.1) for Controls and 55.4% (52.9–59.4) for Treated (p < 0.034). Data are median and quartiles. The artificial pancreas system abolished severe hypoglycemia and outperformed the experienced ICU physician in avoiding clinically significant hypoglycemic excursions.
Highlights
The importance of tight glucose control (TGC) in Intensive care unit (ICU) patients first came to light in 2001 with Van den Berge’s large prospective study that demonstrated improved morbidity and mortality rates when ICU patients had their blood glucose levels controlled to a normal range through use of an intravenous insulin infusion [1]
As both moderate and severe hypoglycemia have been associated with increasing ICU mortality rates, avoiding these episodes must be a priority of any glucose control method [9,10,11]
The artificial pancreas system outperformed the conventional manual treatment executed by an ICU physician regarding glucose control
Summary
The importance of tight glucose control (TGC) in ICU patients first came to light in 2001 with Van den Berge’s large prospective study that demonstrated improved morbidity and mortality rates when ICU patients had their blood glucose levels controlled to a normal range through use of an intravenous insulin infusion [1]. The initial TGC enthusiasm was tempered by subsequent reports from large follow-up studies with less favorable outcomes [7, 8] These studies revealed that applying TGC in common ICUs, where blood glucose measuring methods with poor precision and accuracy commonly are used, caused a higher incidence of deleterious severe hypoglycemic (< 2.2 mmol/L) events. As both moderate and severe hypoglycemia have been associated with increasing ICU mortality rates, avoiding these episodes must be a priority of any glucose control method [9,10,11]. These are all open loop methods that require manual: (1) measurement of the glucose level, (2) input of this level into the insulin dosing calculator, and (3) adjustment of the intravenous infusion rate
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