Evaluation of the Effects of Insufficient Blood Volume Samples on the Performance of Blood Glucose Self-Test Meters

Pfützner, Andreas; Schipper, Christina; Ramljak, Sanja; Flacke, Frank; Sieber, Jochen; Forst, Thomas; Musholt, Petra B.

doi:10.1177/193229681300700612

Cited by 24 publications

(14 citation statements)

References 15 publications

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“…Underfilling the test strip can introduce errors >20% in some BGMs. In another study, only 5 of 31 glucose meters were able to maintain 100% accuracy (either giving the correct reading or rejecting the reading appropriately) when test strips were deliberately underfilled (160).…”

Section: What Impacts Accuracy?mentioning

confidence: 99%

American Association Of Clinical Endocrinologists And American College Of Endocrinology 2016 Outpatient Glucose Monitoring Consensus Statement

et al. 2016

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Section: What Impacts Accuracy?mentioning

confidence: 99%

American Association Of Clinical Endocrinologists And American College Of Endocrinology 2016 Outpatient Glucose Monitoring Consensus Statement

et al. 2016

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“…A limiting aspect of this study is that glucose measurements in a controlled laboratory environment by healthcare professionals or well-trained study personnel, as outlined by ISO 15197 clause 6.3, tend to lead to more accurate results than lay-user measurements 32 33. Deviations between experts’ measurement results and those of lay-users can be traceable to device specific requirements (eg, insufficient blood volume)34 and/or to non–device-specific sources of error (eg, contamination of puncture site with glucose-containing substances) 35 36…”

Section: Discussionmentioning

confidence: 99%

System accuracy evaluation of 18 CE-marked current-generation blood glucose monitoring systems based on EN ISO 15197:2015

Pleus

Baumstark

Jendrike

et al. 2020

BMJ Open Diab Res Care

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ObjectiveAccuracy of 18 current-generation blood glucose monitoring systems (BGMS) available in Europe was evaluated applying criteria adapted from EN ISO 15197:2015 with one reagent system lot. BGMS were selected based on market research data.Research design and methodsThe BGMS ABRA, Accu-Chek Guide, AURUM, CareSens Dual, CERA-CHEK 1CODE, ContourNext One, eBsensor, FreeStyle Freedom Lite, GL50 evo, GlucoCheck GOLD, GlucoMen areo 2K, GluNEO, MyStar DoseCoach, OneTouch Verio Flex, Pic GlucoTest, Rightest GM700S, TRUEyou, and WaveSense JAZZ Wireless were tested using capillary blood from 100 different subjects and assessing the percentage of results within ±15 mg/dL (0.83 mmol/L) or 15% of comparison method results for BG concentrations below or above 100 mg/dL (5.55 mmol/L), respectively. In addition, the minimal deviation from comparison method results within which ≥95% of results of the respective BGMS were found was calculated.ResultsIn total, 14 BGMS had ≥95% of results within ±15 mg/dL (0.83 mmol/L) or ±15% and 3 BGMS had ≥95% of results within ±10 mg/dL (0.55 mmol/L) or ±10% of the results obtained with the comparison method. The smallest deviation from comparison method results within which ≥95% of results were found was ±7.7 mg/dL (0.43 mmol/L) or ±7.7%; the highest deviation was ±19.7 mg/dL (1.09 mmol/L) or ±19.7%.ConclusionsThis accuracy evaluation shows that not all CE-labeled BGMS fulfill accuracy requirements of ISO 15197 reliably and that there is considerable variation even among BGMS fulfilling these criteria. This safety-related information should be taken into account by patients and healthcare professionals when making therapy decisions.Trial registration numberNCT03737188.

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“…As every blood glucose meter is slightly different, no two tests of the same droplet of blood are likely to produce the same result. This is partly attributable to the large array of interfering factors which may influence the results, including blood oxygen concentrations and humidity , haematocrit , temperature and altitude , but also the fact that no technology is 100% accurate, with measurement biases of between (‐) 14.1% and (+) 12.4%, common within the glucose monitors currently in use within the NHS . For this reason, we defined ‘clinical equivalence’ as the ability to conform to the recently updated international standard for meter accuracy currently adopted by the NHS, the Conformité Européene ISO‐15197:2013 guidelines for blood glucose measurement.…”

Section: Methodsmentioning

confidence: 99%

Promoting health and reducing costs: a role for reform of self‐monitoring of blood glucose provision within the National Health Service

et al. 2015

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The study uncovered considerable variation in the price paid by the National Health Service for self-monitoring of blood glucose, which could not be explained by the availability of advanced meter features. A standardized approach to self-monitoring of blood glucose prescribing could achieve significant efficiency savings for the National Health Service, whilst increasing overall utilisation and improving safety for those currently using systems that fail to meet acceptable standards for measurement accuracy.

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Evaluation of the Effects of Insufficient Blood Volume Samples on the Performance of Blood Glucose Self-Test Meters

Cited by 24 publications

References 15 publications

American Association Of Clinical Endocrinologists And American College Of Endocrinology 2016 Outpatient Glucose Monitoring Consensus Statement

American Association Of Clinical Endocrinologists And American College Of Endocrinology 2016 Outpatient Glucose Monitoring Consensus Statement

System accuracy evaluation of 18 CE-marked current-generation blood glucose monitoring systems based on EN ISO 15197:2015

Promoting health and reducing costs: a role for reform of self‐monitoring of blood glucose provision within the National Health Service

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