Abstract
This clinical study aimed to compare a novel and conventional artificial pancreas (AP) used in surgical patients for perioperative glycemic control, with respect to usability, blood glucose measurements, and glycemic control characteristics. From July in 2010 to March in 2015, 177 patients underwent perioperative glycemic control using a novel AP. Among them, 166 patients were eligible for inclusion in this study. Intensive insulin therapy (IIT) targeting a blood glucose range of 80–110 mg/dL was implemented in 82 patients (49 %), and the remaining 84 patients (51 %) received a less-intensive regime of insulin therapy. Data were collected prospectively and were reviewed or analyzed retrospectively. A comparison study of 324 patients undergoing IIT for glycemic control using a novel (n = 82) or conventional AP (n = 242) was conducted retrospectively. All patients had no hypoglycemia. The comparison study revealed no significant differences in perioperative mean blood glucose level, achievement rates for target blood glucose range, and variability in blood glucose level achieved with IIT between the novel AP and conventional AP groups. The usability, performance with respect to blood glucose measurement, and glycemic control characteristics of IIT were comparable between novel and conventional AP systems. However, the novel AP was easier to manipulate than the conventional AP due to its smaller size, lower weight, and shorter time for preparation. In the near future, this novel AP system might be accepted worldwide as a safe and useful device for use in perioperative glycemic control.
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McCowen KC, Malhorta A, Bistrian BR. Stress-induced hyperglycemia. Crit Care Clin. 2001;17:107–24.
Finney SJ, Zekveld C, Elia A, Evans TW. Glucose control and mortality in critically ill patients. JAMA. 2003;290:2041–7.
Rady MY, Johnson DJ, Patel BM, et al. Influence of individual characteristics on outcome of glycemic control in intensive care unit patients with or without diabetes mellitus. Mayo Clin Proc. 2005;80:1558–67.
Gabbanelli V, Pantanetti S, Donati A, et al. Correlation between hyperglycemia and mortality in a medical and surgical intensive care unit. Minerva Anesthesiol. 2005;71:717–25.
Ramos M, Khalpey Z, Lipsitz S, et al. Relationship of perioperative hyperglycemia and postoperative infections in patients who undergo general and vascular surgery. Ann Surg. 2008;248:585–91.
Ambiru S, Kato A, Kimura F, et al. Poor postoperative blood glucose control increases surgical site infections after surgery for hepato-biliary-pancreatic cancer: a prospective study in a high-volume institute in Japan. J Hosp Infect. 2008;68:230–3.
Eshuis WJ, Hermanides J, van Dalen JW, et al. Early postoperative hyperglycemia is associated with postoperative complications after pancreatodudenectomy. Ann Surg. 2011;253:739–44.
Ata A, Lee J, Bestle SL, et al. Postoperative hyperglycemia and surgical site infection in general surgery patients. Arch Surg. 2010;145:858–64.
Hanazaki K, Kitagawa H, Yatabe T, et al. Perioperative intensive insulin therapy using an artificial endocrine pancreas with closed-loop glycemic control system: the effects of no hypoglycemia. Am J Surg. 2014;207:935–41.
Hanazaki K, Yatabe T, Kobayashi M, et al. Perioperative glycemic control using an artificial endocrine pancreas in patients undergoing total pancreatectomy: tight glycemic control may be justified in order to avoid brittle diabetes. Biomed Mater Eng. 2013;23:109–16.
Hanazaki K, Namikawa T. Development of perioperative glycemic control using an artificial endocrine pancreas. Conf Proc IEEE Eng Med Biol Soc. 2013;2013:5719–22.
Murad MH, Coburn JA, Coto-Yglesias F, et al. Glycemic control in non-critically ill hospitalized patients: a systematic review and meta-analysis. J Clin Endocrinol Metab. 2012;97:49–58.
Tsukamoto Y, Okabayashi T, Hanazaki K. Progressive artificial endocrine pancreas: the era of novel perioperative blood glucose control for surgery. Surg Today. 2011;41:1344–51.
Tsukamoto Y, Kinoshita Y, Kitagawa H, et al. Evaluation of a novel artificial pancreas: closed loop glycemic control system with continuous blood glucose monitoring. Artif Organs. 2013;37:E67–73.
Yamashita K, Okabayashi T, Yokoyama T, et al. The accuracy of continuous blood glucose monitor during surgery. Anesth Analg. 2008;106:160–3.
Yamashita K, Okabayashi T, Yokoyama T, et al. Accuracy and reliability of continuous blood glucose monitor in post-surgical patients. Acta Anaesthesiol Scand. 2009;53:66–71.
Yatabe T, Yamazaki R, Kitagawa H, et al. The evaluation of the ability of closed-loop glycemic control device to maintain the blood glucose concentration in intensive unit patients. Crit Care Med. 2011;39:575–8.
Harris JA, Benedict FG. A biometric study of human basal metabolism. Proc Natl Acad Sci USA. 1918;4:370–3.
Workgroup on Hypoglycemia. American Diabetes Association. Defining and reporting hypoglycemia in diabetes: a report from the American Diabetes Association Workgroup on Hypoglycemia. Diabetes Care. 2005;28:1245–9.
Hanazaki K, Maeda H, Okabayashi T. Tight perioperative glycemic control using an artificial endocrine pancreas. Surg Today. 2010;40:1–7.
Duncan A. Hyperglycemia and perioperative glucose management. Curr Pharm Des. 2012;18:6195–203.
Egi M, Bellomo R, Stachowski E, et al. Variability of blood glucose concentration and short-term mortality in critically ill patients. Anesthesiology. 2006;105:244–52.
Hermanides J, Vriesendorp TM, Bosman RJ, et al. Glucose variability is associated with intensive care unit mortality. Crit Care Med. 2010;38:838–42.
Munekage M, Yatabe T, Kitagawa H, et al. An artificial pancreas provided a novel model of blood glucose level variability in beagles. J Artif Organs. 2015;18:387–90.
Van den Berghe G, Wouters P, Weekers F, et al. Intensive insulin therapy in critically ill patients. N Engl J Med. 2001;345:1359–67.
Van den Berghe G, Wilmer A, Hermans G, et al. Intensive insulin therapy in medical ICU. N Engl J Med. 2006;354:449–61.
Wiener RS, Wiener DC, Larson RJ. Benefits and risks of tight glucose control in critically ill adults: a meta-analysis. JAMA. 2008;300:933–44.
The NICE-SUGAR Study Investigators. Intensive versus conventional glucose control in critically ill patients. N Engl J Med. 2009;360:1283–97.
Griesdale DE, de Souza RJ, van Dam RM, et al. Intensive insulin therapy and mortality among critically ill patients: a meta-analysis including NICE-SUGAR study data. CMAJ. 2009;180:821–7.
Mibu K, Yatabe T, Hanazaki K. Blood glucose control using an artificial pancreas reduces the workload of ICU nurses. J Artif Organs. 2012;15:71–6.
Maeda H, Hanazaki K. Pancreatogenic diabetes after pancreatic resection. Pancreatology. 2011;11(268–7):6.
Maeda H, Okabayashi T, Yatabe T, et al. Perioperative intensive insulin therapy using artificial endocrine pancreas in patients undergoing pancreatectomy. World J Gastroenterol. 2009;15:4111–5.
Okabayashi T, Nishimori I, Maeda H, et al. Effect of intensive insulin therapy using a closed loop glycemic control system in hepatic resection patients: a prospective randomized clinical trial. Diabetes Care. 2009;32:1425–7.
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This study was supported by the Japan Ministry of Education, Culture, Sports, Science, and Technology, The Kochi University President’s Discretionary Grant, and grant from Nikkiso CO., Ltd.
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Namikawa, T., Munekage, M., Kitagawa, H. et al. Comparison between a novel and conventional artificial pancreas for perioperative glycemic control using a closed-loop system. J Artif Organs 20, 84–90 (2017). https://doi.org/10.1007/s10047-016-0926-5
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DOI: https://doi.org/10.1007/s10047-016-0926-5