[en] The management reporting and assessment of glycemic control lacks standardization. The use of different methods to measure the blood glucose concentration and to report the performance of insulin treatment yields major disparities and complicates the interpretation and comparison of clinical trials. We convened a meeting of 16 experts plus invited observers from industry to discuss and where possible reach consensus on the most appropriate methods to measure and monitor blood glucose in critically ill patients and on how glycemic control should be assessed and reported. Where consensus could not be reached, recommendations on further research and data needed to reach consensus in the future were suggested. Recognizing their clear conflict of interest, industry observers played no role in developing the consensus or recommendations from the meeting. Consensus recommendations were agreed for the measurement and reporting of glycemic control in clinical trials and for the measurement of blood glucose in clinical practice. Recommendations covered the following areas: How should we measure and report glucose control when intermittent blood glucose measurements are used? What are the appropriate performance standards for intermittent blood glucose monitors in the ICU? Continuous or automated intermittent glucose monitoring - methods and technology: can we use the same measures for assessment of glucose control with continuous and intermittent monitoring? What is acceptable performance for continuous glucose monitoring systems? If implemented, these recommendations have the potential to minimize the discrepancies in the conduct and reporting of clinical trials and to improve glucose control in clinical practice. Furthermore, to be fit for use, glucose meters and continuous monitoring systems must match their performance to fit the needs of patients and clinicians in the intensive care setting.
Desaive, Thomas ; Université de Liège - ULiège > Département d'astrophys., géophysique et océanographie (AGO) > Thermodynamique des phénomènes irréversibles
Van den Berghe G, Wouters P, Weekers F, Verwaest C, Bruyninckx F, Schetz M, Vlasselaers D, Ferdinande P, Lauwers P, Bouillon R. Intensive insulin therapy in critically ill patients. N Engl J Med 2001, 345:1359-1367. 10.1056/NEJMoa011300, 11794168.
Kanji S, Buffie J, Hutton B, Bunting PS, Singh A, McDonald K, Fergusson D, McIntyre LA, Hebert PC. Reliability of point-of-care testing for glucose measurement in critically ill adults. Crit Care Med 2005, 33:2778-2785. 10.1097/01.CCM.0000189939.10881.60, 16352960.
Mackenzie I, Whitehouse T, Nightingale P. The metrics of glycaemic control in critical care. Intensive Care Med 2011, 37:435-443. 10.1007/s00134-010-2103-2, 21210080.
Hoedemaekers CW, Klein Gunnewiek JM, Prinsen MA, Willems JL, Van der Hoeven JG. Accuracy of bedside glucose measurement from three glucometers in critically ill patients. Crit Care Med 2008, 36:3062-3066. 10.1097/CCM.0b013e318186ffe6, 18824915.
Scott MG, Bruns DE, Boyd JC, Sacks DB. Tight glucose control in the intensive care unit: are glucose meters up to the task?. Clin Chem 2009, 55:18-20.
Van den Berghe G, Wilmer A, Hermans G, Meersseman W, Wouters PJ, Milants I, Van Wijngaerden E, Bobbaers H, Bouillon R. Intensive insulin therapy in the medical ICU. N Engl J Med 2006, 354:449-461. 10.1056/NEJMoa052521, 16452557.
Brunkhorst FM, Engel C, Bloos F, Meier-Hellmann A, Ragaller M, Weiler N, Moerer O, Gruendling M, Oppert M, Grond S, Olthoff D, Jaschinski U, John S, Rossaint R, Welte T, Schaefer M, Kern P, Kuhnt E, Kiehntopf M, Hartog C, Natanson C, Loeffler M, Reinhart K, German Competence Network Sepsis (SepNet) Intensive insulin therapy and pentastarch resuscitation in severe sepsis. N Engl J Med 2008, 358:125-139. 10.1056/NEJMoa070716, 18184958, German Competence Network Sepsis (SepNet).
Preiser JC, Devos P, Ruiz-Santana S, Mélot C, Annane D, Groeneveld J, Iapichino G, Leverve X, Nitenberg G, Singer P, Wernerman J, Joannidis M, Stecher A, Chioléro R. 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. 10.1007/s00134-009-1585-2, 19636533.
NICE-SUGAR Study Investigators: Intensive versus conventional glucose control in critically ill patients. N Engl J Med 2009, 360:1346-1349. 10.1056/NEJMe0901507, 19318385, NICE-SUGAR Study.
Taylor JH, Beilman GJ. Hyperglycemia in the intensive care unit: no longer just a marker of illness severity. Surg Infect (Larchmt) 2005, 6:233-245. 10.1089/sur.2005.6.233, 16128630.
Egi M, Bellomo R, Stachowski E, French CJ, Hart GK, Taori G, Hegarty C, Bailey M. Hypoglycemia and outcome in critically ill patients. Mayo Clin Proc 2010, 85:217-224. 10.4065/mcp.2009.0394, 2843109, 20176928.
Egi M, Bellomo R, Stachowski E, French CJ, Hart G. Variability of blood glucose concentration and short-term mortality in critically ill patients. Anesthesiology 2006, 105:244-252. 10.1097/00000542-200608000-00006, 16871057.
Dungan K, Chapman J, Braithwaite SS, Buse J. Glucose measurement: confounding issues in setting targets for inpatient management. Diabetes Care 2007, 30:403-409. 10.2337/dc06-1679, 17259520.
Eslami S, Taherzadeh Z, Schultz MJ, Abu-Hanna A. Glucose variability measures and their effect on mortality: a systematic review. Intensive Care Med 2011, 37:583-593. 10.1007/s00134-010-2129-5, 3058514, 21279326.
Van Herpe T, Mesotten D, Wouters PJ, Herbots J, Voets E, Buyens J, De Moor B, Van den Berghe G. 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. 10.2337/dc12-0584, 22961576.
Finkielman JD, Oyen LJ, Afessa B. Agreement between bedside blood and plasma glucose measurement in the ICU setting. Chest 2005, 127:1749-1751. 10.1378/chest.127.5.1749, 15888855.
Lyon ME, Baskin LB, Braakman S, Presti S, Dubois J, Shirey T. Interference studies with two hospital-grade and two home-grade glucose meters. Diabetes Technol Ther 2009, 11:641-647. 10.1089/dia.2009.0035, 19821756.
Boyd JC, Bruns DE. Monte Carlo simulation in establishing analytical quality requirements for clinical laboratory tests meeting clinical needs. Methods Enzymol 2009, 467:411-433.
Breton MD, Kovatchev BP. Impact of blood glucose self-monitoring errors on glucose variability, risk for hypoglycemia, and average glucose control in type 1 diabetes: an in silico study. J Diabetes Sci Technol 2010, 4:562-570. 2901032, 20513321.
Clarke WL, Cox D, Gonder-Frederick LA, Carter W, Pohl SL. Evaluating clinical accuracy of systems for self-monitoring of blood glucose. Diabetes Care 1987, 10:622-628. 10.2337/diacare.10.5.622, 3677983.
Brunner R, Kitzberger R, Miehsler W, Herkner H, Madl C, Holzinger U. Accuracy and reliability of a subcutaneous continuous glucose-monitoring system in critically ill patients. Crit Care Med 2011, 39:659-664. 10.1097/CCM.0b013e318206bf2e, 21221002.
US Department of Health and Human Services Clinical Laboratory Improvement Amendments of 1988; final rules and notice. 42 CFR Part 493. Federal Register 1992, 57:7188-7288. US Department of Health and Human Services.
Jansen RT, Slingerland RJ. SKML - quality mark for point-of-care test (POCT) glucose meters and glucose meters for home-use. Clin Chem Lab Med 2010, 48:1021-1027.
Royal College of Pathologists of Australia Quality Assurance Program Revision of Allowable Limits of Performance 2010, Royal College of Pathologists of Australia Quality Assurance Program., http://www.westgard.com/rcpa-australasian-quality-requirements.htm
Karon BS, Gandhi GY, Nuttall GA, Bryant SC, Schaff HV, McMahon MM, Santrach PJ. Accuracy of Roche Accu-Chek Inform whole blood capillary, arterial, and venous glucose values in patients receiving intensive intravenous insulin therapy after cardiac surgery. Am J Clin Pathol 2007, 127:919-926. 10.1309/6RFQCKAAJGKWB8M4, 17509989.
Sinha S, Jayaram R, Hargreaves CG. Fatal neuroglycopaenia after accidental use of a glucose 5% solution in a peripheral arterial cannula flush system. Anaesthesia 2007, 62:615-620. 10.1111/j.1365-2044.2007.04989.x, 17506743.
Oliver NS, Toumazou C, Cass AEG, Johnston DG. Glucose sensors: a review of current and emerging technology. Diabetic Med 2009, 26:197-210. 10.1111/j.1464-5491.2008.02642.x, 19317813.
