Efficacy and safety of glucose control with Space GlucoseControl in the medical intensive care unit--an open clinical investigation.
BACKGROUND
We aimed to investigate the performance of the Space GlucoseControl system (SGC) (B. Braun, Melsungen, Germany) in medical critically ill patients. The SGC is a nurse-driven, computer-assisted device for glycemic control combining infusion pumps with the enhanced Model Predictive Control algorithm.


METHODS
The trial was designed as a single-center, open clinical investigation in a nine-bed medical intensive care unit in a tertiary center in Graz, Austria. Efficacy was assessed by percentage of time within the target range (4.4-8.3 mmol/L; primary end point), mean blood glucose, and sampling interval. Safety was assessed by the number of hypoglycemic episodes (≤2.2 mmol/L).


RESULTS
Twenty mechanically ventilated patients (age, 63±16 years; body mass index, 31.0±10.7 kg/m(2); Acute Physiology and Chronic Health Evaluation II score, 25.4±6.3; 14 males; six with diabetes) were included for a period of 7.0±3.6 days. Time within target range was 83.4±8.9% (mean±SD), and mean arterial blood glucose was 6.8±0.4 mmol/L. No severe hypoglycemic episodes (<2.2 mmol/L) occurred, and the percentage of time within 2.2 and 3.3 mmol/L was low (0.03±0.07%). The sampling interval was 2.0±0.4 h. The mean insulin dose was 93.5±80.1 IU/day, and the adherence to the given insulin dose advice was high (98.3%). A total of 11 unintended therapy interruptions (0.08 events/treatment day) caused by software problems occurred in four patients.


CONCLUSIONS
SGC is a safe and efficient method to control blood glucose in critically ill patients in the medical intensive care unit.
Division of Endocrinology and Metabolism, Medical University of Graz, Auenbruggerplatz 15, Graz, Austria. karin.amrein@medunigraz.at
Karin
K
Amrein
Martin
M
Ellmerer
Roman
R
Hovorka
Norman
N
Kachel
Heike
H
Fries
Dirk
D
von Lewinski
Karlheinz
K
Smolle
Thomas R
TR
Pieber
Johannes
J
Plank
D000368:Aged; D000465:Algorithms; D001317:Austria; D001786:Blood Glucose / Q000378:metabolism*; D016638:Critical Illness; D003920:Diabetes Mellitus / Q000097:blood* / Q000188:drug therapy / Q000451:nursing; D004360:Drug Therapy, Computer-Assisted; D005260:Female; D006801:Humans; D006943:Hyperglycemia / Q000097:blood* / Q000188:drug therapy / Q000451:nursing; D007003:Hypoglycemia / Q000097:blood* / Q000188:drug therapy / Q000451:nursing; D007332:Insulin Infusion Systems; D007333:Insulin Resistance; D007362:Intensive Care Units; D008297:Male; D008875:Middle Aged; D015203:Reproducibility of Results; D013997:Time Factors; D016896:Treatment Outcome
D001786:Blood Glucose