Could Susceptibility to Low Hematocrit Interference Have Compromised the Results of the NICE-SUGAR Trial?

Cembrowski, George S.; Tran, Dai Q.; Slater-MacLean, Linda; Chin, Dat; Gibney, R. T. Noel; Jacka, Michael J.

doi:10.1373/clinchem.2010.146217

Cited by 27 publications

(20 citation statements)

References 6 publications

(1 reference statement)

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“…Contrary, when using a handheld blood glucose meter measuring capillary blood, the proportion of data points outside the allowed error zone rose to 27%. The rise in mortality rate in patients on intensive insulin therapy in the NICE-SUGAR may thus be related to the use of variable blood sampling sites and inaccurate blood glucose meters unsuitable for use in critically ill patients [29]. Simulation modeling for tight glycemic control has revealed that large dosing errors occur often when a total error of 20% is accepted for glucose meters [30].…”

Section: Is Nice-sugar Evidence Against Blood Glucose Control?mentioning

confidence: 99%

Glycemic Targets and Approaches to Management of the Patient with Critical Illness

Mesotten

Berghe

2011

Curr Diab Rep

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Hyperglycemia during critical illness is associated with adverse outcome. The proof-of-concept Leuven studies assessed causality, and revealed that targeting strict normoglycemia (80-110 mg/dL) with insulin improved outcome compared with tolerating hyperglycemia to the renal threshold (215 mg/dL). A large multicenter trial (NICE-SUGAR [Normoglycaemia in Intensive Care Evaluation and Survival Using Glucose Algorithm Regulation]) found an intermediate blood glucose target (140-180 mg/dL) safer than targeting normoglycemia. Differences in design and in execution of glycemic control at the bedside may have contributed to these results. In NICE-SUGAR (Normoglycaemia in Intensive Care Evaluation and Survival Using Glucose Algorithm Regulation), the blood-glucose target range in the control group was lower, there were problems to reach and maintain normoglycemia in the intervention group, and inaccurate handheld blood glucose meters and variable blood sampling sites were allowed. Inaccurate tools led to insulin-dosing errors with consequently (undetected) hypoglycemia and unacceptable blood glucose variability. Also, the studies were done superimposed upon different nutritional strategies. Thus, such differences do not allow simple, evidence-based recommendations for daily practice, but an intermediate blood glucose target may be preferable while awaiting better tools to facilitate safely reaching normoglycemia.

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Section: Is Nice-sugar Evidence Against Blood Glucose Control?mentioning

confidence: 99%

Glycemic Targets and Approaches to Management of the Patient with Critical Illness

Mesotten

Berghe

2011

Curr Diab Rep

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“…Other factors, however, may also do the same, most notably anemia, which is common in critically ill patients, and which may occur rapidly, and be large in degree. In the NICE-SUGAR study, Cembrowski [29] observed differences in sensitivity to fluctuations in hematocrit in 5 of the 7 test strip lots used at his institution and thought that falsely elevated glucose levels may have delayed recognition of true hypoglycemia in the study subjects, delaying treatment and contributing to adverse outcomes. Although there are newer POC glucose meters which use a new technique called dynamic electrochemistry [30,31] that are supposedly less sensitive to variations in hematocrit, these techniques may also be susceptible to other interferences as well.…”

Section: Problems In Inpatient Care Settingsmentioning

confidence: 99%

Interfering Factors in Quality of Glucose Measurement

Hellman¹

2014

Frontiers in Diabetes

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The use of point-of-care (POC) glucose meters has revolutionized the measurement of blood glucose, but the new technologies have also introduced challenges due to interfering factors which may affect the accuracy of the measurements. Although new regulatory standards have just been proposed, both the ISO 15197 revised standard and the two new FDA standards, none of these standards solve some of the current problems faced by the clinicians and patients. Among the most serious problems are clinical 'outliers', where the POC glucose measurement is misleading, leading to clinical errors and patient harm. In addition to the above issues, this chapter looks at the special problems of using POC glucose measurement in inpatient units and particularly in critical care settings, the impact of glucose meter accuracy in clinical decisions and the pitfalls that may occur, the distinction between total analytical error and the total error (which is usually significantly larger and more important clinically), and the problems in pediatric care which add to the complexity of ascertaining the true glucose values of the patient. We provide recommendations for changes in both regulatory bodies, both for premarket approval and postmarket monitoring of both POC glucose devices and glucose reagent strips. © 2015 S. Karger AG, BaselThe development of point-of-care (POC) glucose meters has revolutionized the measurement of blood glucose both for in-and outpatients, greatly adding to the tools available for the care of diabetes and resulting in improved clinical outcomes. But with the new technology have come challenges, for the new meters have interfering factors that need to be understood and dealt with by those who use and rely upon the information derived from POC glucose meters.The invention of the first widely used POC blood glucose measurement tool, the Dextrostix, was in 1963 [1], followed 7 years later by the Ames Reflectance Meter. The use of POC glucose meters has continued to increase every year. In 2008, more than 44 million tests were performed daily worldwide. POC glucose testing resulted in USD 8.8 billion in annual revenue in 2008 [2]. The glucose meters and strips have

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“…The degree of hematocrit interference with glucose tests strips shows lot-to-lot variation, with Hellman also wondering whether such variability might be related to the findings of adverse outcome of intensive glycemic control in NICE-SUGAR (45). Hypoglycemia is not, of course, the only issue for hospitalized diabetic patients; Hellman reviewed a Medicare identification of “things that should never happen but did,” with 14,929 episodes of diabetic ketoacidosis and hyperosmolar coma developing among hospitalized patients in 2007.…”

Section: Point-of-care Devices For Management Of Diabetesmentioning

confidence: 99%

Diabetes Treatment and Cardiovascular Safety

Bloomgarden

2011

Diabetes Care

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Could Susceptibility to Low Hematocrit Interference Have Compromised the Results of the NICE-SUGAR Trial?

Cited by 27 publications

References 6 publications

Glycemic Targets and Approaches to Management of the Patient with Critical Illness

Glycemic Targets and Approaches to Management of the Patient with Critical Illness

Interfering Factors in Quality of Glucose Measurement

Diabetes Treatment and Cardiovascular Safety

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