Investigation of the Accuracy of 18 Marketed Blood Glucose Monitors

Klonoff, David C.; Parkes, Joan Lee; Kovatchev, Boris; Kerr, David; Bevier, Wendy C.; Brazg, Ronald; Christiansen, Mark P.; Bailey, Timothy S.; Nichols, James H.; Kohn, Michael A.

doi:10.2337/dc17-1960

Cited by 117 publications

(99 citation statements)

References 11 publications

(10 reference statements)

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“…These findings are different from previous recent studies that showed similar measurements for the two methods [10,11,14,22]. Nonetheless, searching the available literature for a comparison with the present results was difficult because most studies on the accuracy of the point-ofcare devices compared capillary (finger stick) glucose measurements with the glucose measures, and were performed in inpatient settings [23]. The present results may be affected by the fact that glucose meters are calibrated to account for differences between capillary blood and venous blood.…”

Section: Discussioncontrasting

confidence: 99%

Utility of point‐of‐care vs reference laboratory testing for the evaluation of glucose levels

et al. 2019

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Aims To assess the level of agreement between point-of-care and laboratory reference glucose values in defining glycaemic status.Methods We analysed 1292 overweight/obese, non-institutionalized participants, aged 40-65 years, in the San Juan Overweight Adults Longitudinal Study. Fasting venous blood glucose was determined using a point-of-care Bayer Contour Blood Glucose Meter and by Vitros System 250 instrument (laboratory). American Diabetes Association thresholds were used to classify participants into normoglycaemia (< 5.6 mmol/l), prediabetes (5.6 to 6.9 mmol/l), or diabetes groups (≥ 7 mmol/l).Results Bland-Altman plot analysis showed a slope of 0.04 (P=0.002) for the regression between the mean difference and the average of the two methods. The slopes were significantly different from zero among people with normoglycaemia (b=-0.57, P<0.001), and prediabetes (b=-0.75, P<0.001) but not among people with diabetes (b=-0.02, P=0.68). When the prediabetes and diabetes groups were merged into one group, the slope was 0.01, and the glucose values remained similar using the two methods (P=0.76).Conclusion Point-of-care blood glucose measurement may be useful to screen people with diabetes, and to assess glucose among individuals with diabetes where blood can be drawn, but laboratory tests are unavailable or untimely.

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Section: Discussioncontrasting

confidence: 99%

Utility of point‐of‐care vs reference laboratory testing for the evaluation of glucose levels

et al. 2019

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“…International Organization for Standardization (ISO) and US Food and Drug Administration (FDA) standards require accuracy within 20% of the actual value in 95% of samples with glucose levels ≥75 mg/dL and ±15 mg/dL for glucose levels <75 mg/dL [12]. A recent analysis by the Diabetes Technology Society Blood Glucose Monitor System (BGMS) Surveillance Program revealed that only 6 of 18 commercially available SMBG meters met those standards [15]. In contrast, continuous glucose monitoring (CGM) devices take interstitial glucose readings every 5 minutes and provide a trend analysis.…”

Section: Challenges Of Accurately Measuring Glucose Levelsmentioning

confidence: 99%

Management of hypoglycemia in older adults with type 2 diabetes

Freeman

2019

Postgraduate Medicine

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Treatment of older adults with type 2 diabetes (T2D) is complex because they represent a heterogeneous group with a broad range of comorbidities, functional abilities, socioeconomic status, and life expectancy. Older adults with T2D are at high risk of recurring hypoglycemia, a condition associated with marked morbidity and mortality, because their counter-regulatory mechanism to hypoglycemia is attenuated, and recurring hypoglycemic episodes can lead to hypoglycemia unawareness. In addition, polypharmacy, a result of multiple chronic comorbidities (including heart disease, stroke, and chronic kidney disease), can increase the risk of severe hypoglycemia, especially when patients are taking sulfonylureas or insulin. Often the signs of hypoglycemia are nonspecific (sweating, dizziness, confusion, visual disturbances) and are mistaken for neurological symptoms or dementia. Consequences of hypoglycemia include acute and long-term cognitive changes, cardiac arrhythmia and myocardial infarction, serious falls, frailty, and death, often resulting in hospitalization, which come at a high economic cost. The American Diabetes Association has recently added three new recommendations regarding hypoglycemia in the elderly, highlighting individualized pharmacotherapy with glucose-lowering agents with a low risk of hypoglycemia and proven cardiovascular safety, avoidance of overtreatment, and simplifying treatment regimens while maintaining HbA1c targets. Thus, glycemic goals can be relaxed in the older population as part of individualized care, and physicians must make treatment decisions that best serve their patients' circumstances. This article highlights the issues faced by older people with T2D, the risk factors for hypoglycemia in this population, and the challenges faced by health care providers regarding glycemic management in this patient group.

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“…Moreover, SMBG may not be feasible (or desirable) at work or school, and it is susceptible to user error due to poor testing technique, inadequate blood sample, presence of contaminating substances on fingers, and other factors (32), all of which can lead to primarily falsely high, but also low, readings. Additionally, postmarketing data on the accuracy and consistency of commercially available SMBG systems demonstrated that many did not meet recommended standards (33).…”

Section: Smbgmentioning

confidence: 99%

Clinical Implications of Real-time and Intermittently Scanned Continuous Glucose Monitoring

Argento²,

et al. 2018

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Two types of continuous glucose monitoring (CGM) systems are now available: real-time CGM (rtCGM) and intermittently scanned (isCGM). Current rtCGM systems automatically transmit a continuous stream of glucose data to the user, provide alerts and active alarms, and transmit glucose data (trend and numerical) in real time to a receiver, smart watch, or smartphone. The current isCGM system provides the same type of glucose data but requires the user to purposely scan the sensor to obtain information, and it does not have alerts and alarms. Both CGM technologies have significant advantages over self-monitoring of blood glucose; however, differences in the features and capabilities of the two approaches must be considered when guiding patient selection of the system that meets their individual needs.

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Investigation of the Accuracy of 18 Marketed Blood Glucose Monitors

Abstract: Cleared BGMs do not always meet the level of analytical accuracy currently required for regulatory clearance. This information could assist patients, professionals, and payers in choosing products and regulators in evaluating postclearance performance.

Cited by 117 publications

References 11 publications

Utility of point‐of‐care vs reference laboratory testing for the evaluation of glucose levels

Utility of point‐of‐care vs reference laboratory testing for the evaluation of glucose levels

Management of hypoglycemia in older adults with type 2 diabetes

Clinical Implications of Real-time and Intermittently Scanned Continuous Glucose Monitoring

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