Research Article | Open Access
Liam M. Fisk, Aaron J. Le Compte, Geoffrey M. Shaw, J. Geoffrey Chase, "Improving Safety of Glucose Control in Intensive Care using Virtual Patients and Simulated Clinical Trials", Journal of Healthcare Engineering, vol. 3, Article ID 249039, 16 pages, 2012. https://doi.org/10.1260/2040-2222.214.171.1245
Improving Safety of Glucose Control in Intensive Care using Virtual Patients and Simulated Clinical Trials
Despite the potential clinical benefits of normalizing blood glucose in critically ill patients, the risk of hypoglycemia is a major barrier to widespread clinical adoption of accurate glycemic control. To compare five glucose control protocols, a validated insulin-glucose system model was employed to perform simulated clinical trials. STAR, SPRINT, UNC, Yale and Glucontrol protocols were assessed over a medical-surgical intensive care unit patient cohort. Results were interpreted separately for patients with low to high sensitivity to insulin, and low to high variability in metabolic state. STAR and SPRINT provided good glucose control with risk of severe hypoglycemia less than 0.05% across all patient groups. UNC also achieved good control for patients with low and medium levels of insulin sensitivity (SI), but risk of severe hypoglycemia was raised for patients with high SI. Glucontrol showed degradation of performance for patients with high metabolic variability.
- J. S. Krinsley, “Association between hyperglycemia and increased hospital mortality in a heterogeneous population of critically ill patients,” Mayo Clin Proc, vol. 78, pp. 1471–1478, 2003.
- D. E. Griesdale, R. J. de Souza, R. M. van Dam et al., “Intensive insulin therapy and mortality among critically ill patients: a meta-analysis including NICE-SUGAR study data,” CMAJ, vol. 180, pp. 821–827, 2009.
- S. Bagshaw, R. Bellomo, M. Jacka et al., “tACM. The impact of early hypoglycemia and blood glucose variability on outcome in critical illness,” Critical Care, vol. 13: R91, 2009.
- M. Egi, R. Bellomo, E. Stachowski, C. J. French, and G. Hart, “Variability of blood glucose concentration and short-term mortality in critically ill patients,” Anesthesiology, vol. 105, pp. 244–252, 2006.
- J. S. Krinsley, “Glycemic variability: a strong independent predictor of mortality in critically ill patients,” Crit Care Med, vol. 36, pp. 3008–3013, 2008.
- G. Van den Berghe, P. J. Wouters, R. Bouillon et al., “Outcome benefit of intensive insulin therapy in the critically ill: Insulin dose versus glycemic control,” Crit Care Med, vol. 31, pp. 359–366, 2003.
- J. G. Chase, G. Shaw, A. Le Compte et al., “Implementation and evaluation of the SPRINT protocol for tight glycaemic control in critically ill patients: a clinical practice change,” Critical Care, vol. 12: R49, 2008.
- J. S. Krinsley, “Effect of an intensive glucose management protocol on the mortality of critically ill adult patients,” Mayo Clin Proc, vol. 79, pp. 992–1000, 2004.
- J. G. Chase, C. G. Pretty, L. Pfeifer et al., “Organ failure and tight glycemic control in the SPRINT study,” Crit Care, vol. 14: R154, 2010.
- J. S. Krinsley and R. Jones, “Cost analysis of intensive glycemic control in critically ill adult patients,” Chest, vol. 129, pp. 644–650, 2006.
- G. Van den Berghe, P. J. Wouters, K. Kesteloot, and D. E. Hilleman, “Analysis of healthcare resource utilization with intensive insulin therapy in critically ill patients,” Crit Care Med, vol. 34, pp. 612–616, 2006.
- R. S. Wiener, D. C. Wiener, and R. J. Larson, “Benefits and risks of tight glucose control in critically ill adults: a meta-analysis,” JAMA, vol. 300, pp. 933–944, 2008.
- E. S. Moghissi, M. T. Korytkowski, M. DiNardo et al., “American Association of Clinical Endocrinologists and American Diabetes Association consensus statement on inpatient glycemic control,” Diabetes Care, vol. 32, pp. 1119–1131, 2009.
- J. Lin, D. Lee, J. Chase, C. Hann, T. Lotz, and X. Wong, “Stochastic Modelling of Insulin Sensitivity Variability in Critical Care,” Biomedical Signal Processing & Control, vol. 1, pp. 229–242, 2006.
- G. Van den Berghe, A. Wilmer, G. Hermans et al., “Intensive insulin therapy in the medical ICU,” N Engl J Med, vol. 354, pp. 449–461, 2006.
- G. Van den Berghe, P. Wouters, F. Weekers et al., “Intensive insulin therapy in the critically ill patients,” N Engl J Med, vol. 345, pp. 1359–1367, 2001.
- A. J. Le Compte, C. G. Pretty, J. Lin, G. M. Shaw, A. Lynn, and J. G. Chase, “Impact of variation in patient response on model-based control of glycaemia in critically ill patients,” Comput Methods Programs Biomed, 2011.
- P. R. Black, D. C. Brooks, P. Q. Bessey, R. R. Wolfe, and D. W. Wilmore, “Mechanisms of insulin resistance following injury,” Ann Surg, vol. 196, pp. 420–435, 1982.
- F. Suhaimi, A. Le Compte, J. C. Preiser et al., “What makes tight glycemic control tight? The impact of variability and nutrition in two clinical studies,” J Diabetes Sci Technol, vol. 4, pp. 284–298, 2010.
- A. Le Compte, J. G. Chase, A. Lynn et al., “Blood Glucose Controller for Neonatal Intensive Care: Virtual Trials Development and First Clinical Trials,” Journal of Diabetes Science and Technology, vol. 3, pp. 1066–1081, 2009.
- S. Korsatko, M. Ellmerer, L. Schaupp et al., “Hypoglycaemic coma due to falsely high point-of-care glucose measurements in an ICU-patient with peritoneal dialysis: a critical incidence report,” Intensive Care Med, vol. 35, pp. 571–572, 2009.
- S. S. Braithwaite, R. Edkins, K. L. Macgregor et al., “Performance of a dose-defining insulin infusion protocol among trauma service intensive care unit admissions,” Diabetes Technol Ther, vol. 8, pp. 476–488, 2006.
- P. A. Goldberg, M. G. Roussel, and S. E. Inzucchi, “Clinical Results of an Updated Insulin Infusion Protocol in Critically Ill Patients,” Diabetes Spectrum, vol. 18, pp. 188–191, 2005.
- J. C. Preiser, P. Devos, S. Ruiz-Santana et al., “A prospective randomised multi-centre controlled trial on tight glucose control by intensive insulin therapy in adult intensive care units: the Glucontrol study,” Intensive Care Med, vol. 35, pp. 1738–1748, 2009.
- A. Evans, G. M. Shaw, A. Le Compte et al., “Pilot proof of concept clinical trials of Stochastic Targeted (STAR) glycemic control,” Ann Intensive Care, vol. 1: 38, 2011.
- R. Hovorka, J. Kremen, J. Blaha et al., “Blood Glucose Control by a Model Predictive Control Algorithm with Variable Sampling Rate Versus a Routine Glucose Management Protocol in Cardiac Surgery Patients: A Randomized Controlled Trial,” J Clin Endocrinol Metab, vol. 92, pp. 2960–2964, 2007.
- J. G. Chase, F. Suhaimi, S. Penning et al., “Validation of a model-based virtual trials method for tight glycemic control in intensive care,” Biomed Eng Online, vol. 9: 84, 2010.
- C. E. Hann, J. G. Chase, J. Lin, T. Lotz, C. V. Doran, and G. M. Shaw, “Integral-based parameter identification for long-term dynamic verification of a glucose-insulin system model,” Comput Methods Programs Biomed, vol. 77, pp. 259–270, 2005.
- W. A. Knaus, E. A. Draper, D. P. Wagner, and J. E. Zimmerman, “APACHE II: a severity of disease classification system,” Crit Care Med, vol. 13, pp. 818–829, 1985.
- J. Lin, N. N. Razak, C. G. Pretty et al., “A physiological Intensive Control Insulin-Nutrition-Glucose (ICING) model validated in critically ill patients,” Comput Methods Programs Biomed, vol. 102, pp. 192–205, 2011.
- S. Penning, A. J. Le Compte, K. T. Moorhead et al., “First pilot trial of the STAR-Liege protocol for tight glycemic control in critically ill patients,” Comput Methods Programs Biomed, 2011.
- X. W. Wong, I. Singh-Levett, L. J. Hollingsworth et al., “A novel, model-based insulin and nutrition delivery controller for glycemic regulation in critically ill patients,” Diabetes Technol Ther, vol. 8, pp. 174–190, 2006.
- J. G. Chase, G. M. Shaw, J. Lin et al., “Targeted glycemic reduction in critical care using closed-loop control,” Diabetes Technol Ther, vol. 7, pp. 274–282, 2005.
- M. Vogelzang, Horst ICvd, and M. W. Nijsten, “Hyperglycaemic Index as a Tool to Assess Glucose Control: A Retrospective Study,” Crit Care, vol. 8, pp. R122–R127, 2004.
- E. A. Ryan, T. Shandro, K. Green et al., “Assessment of the severity of hypoglycemia and glycemic lability in type 1 diabetic subjects undergoing islet transplantation,” Diabetes, vol. 53, pp. 955–962, 2004.
- F. J. Service, G. D. Molnar, J. W. Rosevear, E. Ackerman, L. C. Gatewood, and W. F. Taylor, “Mean amplitude of glycemic excursions, a measure of diabetic instability,” Diabetes, vol. 19, pp. 644–655, 1970.
- D. Aragon, “Evaluation of nursing work effort and perceptions about blood glucose testing in tight glycemic control,” Am J Crit Care, vol. 15, pp. 370–377, 2006.
- I. Mackenzie, S. Ingle, S. Zaidi, and S. Buczaski, “Tight glycaemic control: a survey of intensive care practice in large English hospitals,” Intensive Care Med, vol. 31: 1136, 2005.
- T. Lonergan, A. LeCompte, M. Willacy et al., “A simple insulin-nutrition protocol for tight glycemic control in critical illness: development and protocol comparison,” Diabetes Technol Ther, vol. 8, pp. 191–206, 2006.
Copyright © 2012 Hindawi Publishing Corporation. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.