Randomized evaluation of glycemic control in the medical intensive care unit using real-time continuous glucose monitoring (REGIMEN Trial)

Diabetes Technology and Therapeutics

Volumn 17, Issue 12, 2015, Pages 889-898

  De Block, Christophe E M ^a   Gios, Jens ^b   Verheyen, Nina ^a   Manuel Y Keenoy, Begoña ^c   Rogiers, Peter ^d   Jorens, Philippe G ^b   Scuffi, Cosimo ^e   Van Gaal, Luc F ^a  

^a UNIVERSITY OF ANTWERP   (Belgium)

^b ANTWERP UNIVERSITY HOSPITAL   (Belgium)

^c UNIVERSITY OF ANTWERP   (Belgium)

^d MIDDELHEIM HOSPITAL   (Belgium)

^e Menarini Ricerche SpA   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

GLUCOSE; INSULIN; ANTIDIABETIC AGENT; GLYCOSYLATED HEMOGLOBIN; HEMOGLOBIN A1C PROTEIN, HUMAN;

AGED; APACHE; ARTICLE; BLOOD GLUCOSE METER; BLOOD GLUCOSE MONITORING; CLINICAL ARTICLE; CONTROLLED STUDY; CRITICALLY ILL PATIENT; DIABETIC PATIENT; EVALUATION STUDY; FEMALE; GLUCOSE BLOOD LEVEL; GLYCEMIC CONTROL; HUMAN; HYPOGLYCEMIA; INSULIN INFUSION; INSULIN TREATMENT; INTENSIVE CARE UNIT; MALE; MEASUREMENT ACCURACY; OUTCOME ASSESSMENT; PILOT STUDY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; REAL TIME CONTINUOUS GLUCOSE MONITORING; RISK REDUCTION; SEQUENTIAL ORGAN FAILURE ASSESSMENT SCORE; BELGIUM; BLOOD; CLINICAL TRIAL; COHORT ANALYSIS; DEVICES; DRUG EFFECTS; HYPERGLYCEMIA; INCIDENCE; METABOLISM; MICRODIALYSIS; MIDDLE AGED; MULTICENTER STUDY; PHYSIOLOGIC MONITORING; SINGLE BLIND PROCEDURE; SUBCUTANEOUS TISSUE;

AGED; APACHE; BELGIUM; COHORT STUDIES; FEMALE; GLUCOSE; HEMOGLOBIN A, GLYCOSYLATED; HUMANS; HYPERGLYCEMIA; HYPOGLYCEMIA; HYPOGLYCEMIC AGENTS; INCIDENCE; INSULIN; INSULIN INFUSION SYSTEMS; INTENSIVE CARE UNITS; MALE; MICRODIALYSIS; MIDDLE AGED; MONITORING, PHYSIOLOGIC; PILOT PROJECTS; SINGLE-BLIND METHOD; SUBCUTANEOUS TISSUE;

EID: 84948775532     PISSN: 15209156     EISSN: 15578593     Source Type: Journal    
DOI: 10.1089/dia.2015.0151     Document Type: Article

References (44)

1. De Block C, Manuel-y-Keenoy B, Rogiers P, et al.: Glucose control and use of continuous glucose monitoring in the intensive care unit: a critical review. Curr Diabetes Rev 2008;4:234-244.
2. Kavanagh BP, McCowen KC: Glycemic control in the ICU. N Engl J Med 2010;363:2540-2546.
3. Van den Berghe G, Wouters P, Weekers F, et al.: Intensive insulin therapy in the critically ill patients. N Engl J Med 2001;345:1359-1367.
4. Van den Berghe G, Wilmer A, Hermans G, et al.: Intensive insulin therapy in the medical ICU. N Engl J Med 2006; 354:449-461.
5. Brunkhorst FM, Engel C,Bloos F,etal.: German Competence Network Sepsis (SepNet). Intensive insulin therapy and pentastarch resuscitation in severe sepsis. N Engl JMed 2008; 358:125-139.
6. Preiser JC, Devos P, Ruiz-Santana S, 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 2009;35: 1738-1748.
7. Finfer S, Chittock DR, Su SY, et al.: Intensive versus conventional glucose control in critically ill patients. N Engl J Med 2009;360:1283-1297.
8. Egi M, Bellomo R, Stachowski E, et al.: Variability of blood glucose concentration and short-term mortality in critically ill patients. Anesthesiology 2006;105:244-252.
9. Krinsley JS: Glycemic variability: a strong independent predictor of mortality in critically ill patients. Crit Care Med 2008;36:3008-3013.
10. Meyfroidt G, Keenan DM, Wang X, et al.: Dynamic characteristics of blood glucose time series during the course of critical illness: effects of intensive insulin therapy and relative association with mortality. Crit Care Med 2010;38:1021-1029.
11. Hermanides J, Vriesendorp TM, Bosman RJ, et al.: Glucose variability is associated with intensive care unit mortality. Crit Care Med 2010;38:838-842.
12. Jacobi J, Bircher N, Krinsley J, et al.: Guidelines for the use of an insulin infusion for the management of hyperglycemia in critically ill patients. Crit Care Med 2012;40:3251-3276.
13. Kanji S, Singh A, Tierney M, et al.: Standardization of intravenous insulin therapy improves the efficiency and safety of blood glucose control in critically ill adults. Intensive Care Med 2004;30:804-810.
14. Wilson M, Weinreb J, Hoo GW: Intensive insulin therapy in critical care: a review of 12 protocols. Diabetes Care 2007;30:1005-1011.
15. Shetty S, Inzucchi SE, Goldberg PA, et al.: Adapting to the new consensus guidelines for managing hyperglycemia during critical illness: the updated Yale insulin infusion protocol. Endocr Pract 2012;18:363-370.
16. Holzinger U, Warszawska J, Kitzberger R, et al.: Real-time continuous glucose monitoring in critically ill patients: a prospective randomized trial. Diabetes Care 2010;33:467-472.
17. De Block C, Manuel-y-Keenoy B, Van Gaal L, et al.: Intensive insulin therapy in the intensive care unit: assessment by continuous glucose monitoring. Diabetes Care 2006;29:1750-1756.
18. Holzinger U, Warszawska J, Kitzberger R, et al.: Impact of shock requiring norepinephrine on the accuracy and reliability of subcutaneous continuous glucose monitoring. Intensive Care Med 2009;35:1383-1389.
19. Logtenberg SJ, Kleefstra N, Snellen FT, et al.: Pre-and postoperative accuracy and safety of a real-time continuous glucose monitoring system in cardiac surgical patients: a randomized pilot study. Diabetes Technol Ther 2009;11:31-37.
20. Brunner R, Kitzberger R, Miehsler W, et al.: Accuracy and reliability of a subcutaneous continuous glucose-monitoring system in critically ill patients. Crit Care Med 2011;39:659-664.
21. Siegelaar SE, Barwari T, Hermanides J, et al.: Microcirculation and its relation to continuous subcutaneous glucose sensor accuracy in cardiac surgery patients in the intensive care unit. J Thorac Cardiovasc Surg 2013;146:1283-1289.
22. Knaus WA, Draper EA, Wagner DP, et al.: APACHE II: a severity of disease classification system. Crit Care Med 1985;13:818-829.
23. Vincent JL, Moreno R, Takala J, et al.: The SOFA (Sepsis-related Organ Failure Assessment) score to describe organ dysfunction/failure. Intensive Care Med 1996;22:707-710.
24. Rodbard D: The challenges of measuring glycemic variability. J Diabetes Sci Technol 2012;6:712-715.
25. Service FJ, Molnar GD, Rosevear JW, et al.: Mean amplitude of glycemic excursions, a measure of diabetic instability. Diabetes 1970;19:644-655.
26. McDonnell CM, Donath SM, Vidmar SI, et al.: A novel approach to continuous glucose analysis utilizing glycemic variation. Diabetes Technol Ther 2005;7:253-263.
27. Molnar GD, Taylor WF, Ho MM: Day to day variation of continuously monitored glycemia: a further measure of diabetic instability. Diabetologia 1972;8:342-348.
28. Kovatchev BP, Cox DJ, Gonder-Frederick LA, et al.: Assessment of risk for severe hypoglycemia among adults with IDDM: validation of the Low Blood Glucose Index. Diabetes Care 1998;21:1870-1875.
29. Kovatchev BP, Shields D, Breton M: Graphical and numerical evaluation of continuous glucose sensing time lag. Diabetes Technol Ther 2009;11:139-143.
30. Clarke WL, Cox D, Gonder-Frederick LA, et al.: Evaluating clinical accuracy of systems for self-monitoring of blood glucose. Diabetes Care 1987;10:622-628.
31. Parkes JL, Slatin SL, Pardo S, et al.: A new consensus error grid to evaluate the clinical significance of inaccuracies in the measurement of blood glucose. Diabetes Care 2000;23:1143-1148.
32. Schaupp L, Plank J, Köhler G, et al.: Prediction of glucose concentration in post-cardiothoracic surgery patients using continuous glucose monitoring. Diabetes Technol Ther 2011;13:127-134.
33. Krinsley JS, Preiser JC: Time in blood glucose range 70 to 140 mg/dl >80% is strongly associated with increased survival in non-diabetic critically ill adults. Crit Care 2015;19:179.
34. Juneja R, Roudebush C, Kumar N, et al.: Utilization of a computerized intravenous infusion program to control blood glucose in the intensive care unit. Diabetes Technol Ther 2007;9:232-240.
35. Morris AH, Orme J Jr, Truwit JD, et al.: A replicable method for blood glucose control in critically ill patients. Crit Care Med 2008;36:1787-1795.
36. Chase JG, Shaw G, Le Compte A, et al.: Implementation and evaluation of the SPRINT protocol for tight glycaemic control in critically ill patients: a clinical practice change. Crit Care 2008;12:R49.
37. van Herpe T, Mesotten D, Wouter PJ, et al.: LOGIC-insulin algorithm-guided versus nurse-directed blood glucose control during critical illness. The LOGIC-1 single-center, randomized, controlled clinical trial. Diabetes Care 2013;36:188-194.
38. Kulnik R, Plank J, Pachler C, et al.: Evaluation of implementation of a fully automated algorithm (enhanced model predictive control) in an interaction infusion pump system for establishment of tight glycemic control in medical intensive care unit patients. J Diabetes Sci Technol 2008;2:963-970.
39. Boyd JC, Bruns DE: Effects of measurement frequency on analytical quality required for glucose measurements in intensive care units: assessments by simulation models. Clin Chem 2014;60:644-655.
40. Wilinska ME, Hovorka R: Glucose control in the intensive care unit by use of continuous glucose monitoring: what level of measurement error is acceptable? Clin Chem 2014;60:1500-1509.
41. Van Herpe T, De Moor B, Van den Berghe G, et al.: Modeling of effect of glucose sensor error on insulin dosage and glucose bolus computed by LOGIC-insulin. Crit Chem 2014;60:1510-1518.
42. Finfer S, Wernerman J, Preiser JC, et al.: Clinical review: consensus recommendations on measurement of blood glucose and reporting glycemic control in critically ill adults. Crit Care 2013;17:229.
43. Brunner R, Adelsmayr G, Herkner H, et al.: Glycemic variability and glucose complexity in critically ill patients: a retrospective analysis of continuous glucose monitoring data. Crit Care 2012;16:R175.
44. De Block CEM, Manuel-y-Keenoy B, Rogiers P, et al.: Intensive insulin therapy in the intensive care unit: assessment by continuous glucose monitoring. Response to Radermecker. Diabetes Care 2006;29:2763-2764.