A New, Wireless-enabled Blood Glucose Monitoring System That Links to a Smart Mobile Device: Accuracy and User Performance Evaluation

Christiansen, Mark P.; Greene, Carmine; Pardo, Scott; Warchal-Windham, Mary Ellen; Harrison, Bern; Morin, Robert; Bailey, Timothy S.

doi:10.1177/1932296817691301

Cited by 25 publications

(11 citation statements)

References 12 publications

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“…The other three systems showed slightly better accuracy results for study personnel measurements compared to lay-user measurements. Different studies showed that accuracy achieved by trained study personnel is often better than accuracy achieved by lay-persons [ 11 , 12 , 26 , 27 ]; however, only few user performance evaluations were performed on the basis of procedures described in ISO 15197:2013 [ 25 , 26 , 28 – 30 ].…”

Section: Discussionmentioning

confidence: 99%

User Performance Evaluation of Four Blood Glucose Monitoring Systems Applying ISO 15197:2013 Accuracy Criteria and Calculation of Insulin Dosing Errors

et al. 2018

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IntroductionThe international standard ISO 15197:2013 requires a user performance evaluation to assess if intended users are able to obtain accurate blood glucose measurement results with a self-monitoring of blood glucose (SMBG) system. In this study, user performance was evaluated for four SMBG systems on the basis of ISO 15197:2013, and possibly related insulin dosing errors were calculated. Additionally, accuracy was assessed in the hands of study personnel.MethodsAccu-Chek® Performa Connect (A), Contour® plus ONE (B), FreeStyle Optium Neo (C), and OneTouch Select® Plus (D) were evaluated with one test strip lot. After familiarization with the systems, subjects collected a capillary blood sample and performed an SMBG measurement. Study personnel observed the subjects’ measurement technique. Then, study personnel performed SMBG measurements and comparison measurements. Number and percentage of SMBG measurements within ± 15 mg/dl and ± 15% of the comparison measurements at glucose concentrations < 100 and ≥ 100 mg/dl, respectively, were calculated. In addition, insulin dosing errors were modelled.ResultsIn the hands of lay-users three systems fulfilled ISO 15197:2013 accuracy criteria with the investigated test strip lot showing 96% (A), 100% (B), and 98% (C) of results within the defined limits. All systems fulfilled minimum accuracy criteria in the hands of study personnel [99% (A), 100% (B), 99.5% (C), 96% (D)]. Measurements with all four systems were within zones of the consensus error grid and surveillance error grid associated with no or minimal risk. Regarding calculated insulin dosing errors, all 99% ranges were between dosing errors of − 2.7 and + 1.4 units for measurements in the hands of lay-users and between − 2.5 and + 1.4 units for study personnel. Frequent lay-user errors were not checking the test strips’ expiry date and applying blood incorrectly.ConclusionsData obtained in this study show that not all available SMBG systems complied with ISO 15197:2013 accuracy criteria when measurements were performed by lay-users.Trial RegistrationThe study was registered at ClinicalTrials.gov (NCT02916576).FundingAscensia Diabetes Care Deutschland GmbH.Electronic supplementary materialThe online version of this article (10.1007/s13300-018-0392-6) contains supplementary material, which is available to authorized users.

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Section: Discussionmentioning

confidence: 99%

User Performance Evaluation of Four Blood Glucose Monitoring Systems Applying ISO 15197:2013 Accuracy Criteria and Calculation of Insulin Dosing Errors

et al. 2018

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“…As required by ISO 15197:2013, glucose measurements were performed in a controlled environment by trained personnel, so that results may not be completely representative of the accuracy as perceived by diabetes patients. BGMS often show more accurate results in the hands of trained professionals than in the hands of lay-users, 16-22 and ambient conditions like temperature are also known to possibly affect the measurement results. 23,24 In addition, transport and storage conditions might differ from those experienced by users, because meters, test strips, and control solution were provided by the manufacturer, and thus procured through different channels than those available to users.…”

Section: Discussionmentioning

confidence: 99%

Assessment of System Accuracy, Intermediate Measurement Precision, and Measurement Repeatability of a Blood Glucose Monitoring System Based on ISO 15197

Jendrike

Baumstark

Pleus

et al. 2018

J Diabetes Sci Technol

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Blood glucose monitoring systems (BGMS) are often used by diabetes patients on an insulin regimen as basis for their therapeutic decisions, like administration of insulin or rescue carbohydrates. Accuracy of the results displayed by BGMS is therefore an important issue in the use of BGMS, because only sufficiently high accuracy allows diabetes patients ade quate diabetes control.According to the International Organization for Standard ization's (ISO) standard ISO 15197:2013, which establishes minimum requirements for BGMS for selfmonitoring that should result in acceptable performance and which also describes procedures for demonstrating compliance with these minimum requirements, accuracy comprises the two concepts of trueness and precision. 1 Trueness describes how large the deviation between an average of replicate measurement results and a comparative (ie, reference) results is. Trueness is inversely related to the systematic measurement error (bias), so that maxi mum trueness is achieved in absence of bias. Precision on the 821105D STXXX10.1177/1932296818821105Journal of Diabetes Science and TechnologyJendrike et al. research-article2018Abstract Background: Analytical quality of blood glucose monitoring systems (BGMS) is an important aspect for many diabetes patients. Sufficiently high analytical quality is required for adequate diabetes therapy. Methods:In this study, system accuracy and measurement precision of a BGMS were assessed based on ISO 15197:2013. For system accuracy, this standard requires a specific glucose distribution and at least 95% of results obtained with the BGMS in capillary blood to fall within ±15 mg/dl or ±15% (at glucose concentrations <100 mg/dl or ≥100 mg/dl, respectively) of corresponding comparison method results, and at least 99% of results to be found within clinically acceptable consensus error grid (CEG) zones A and B. Based on ISO 15197:2013, intermediate measurement precision, using control solution, and measurement repeatability, using venous blood samples, were analyzed by calculation of standard deviations (SDs) and coefficients of variation (CV) at glucose concentrations <100 mg/dl or ≥100 mg/dl, respectively, although ISO 15197:2013 does not specify acceptance criteria.Results: The BGMS fulfilled system accuracy requirements with ≥99% of results within ±15 mg/dl or ±15% of the comparison method results, and 100% of results in CEG zones A and B. Intermediate measurement precision analysis showed SD ≤2.2 mg/dl and CV ≤2.3%. Analysis of measurement repeatability showed SD ≤2.1 mg/dl and CV ≤2.4%. Conclusion:System accuracy requirements of ISO 15197:2013 were fulfilled by the BGMS. As ISO 15197:2013 does not specify precision requirements, precision analysis results were compared with those reported for other BGMS in the literature and found to be similar.

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“…Recently, a new blood glucose monitoring meter, the Contour ® Next One, has been engineered, which can be linked via Bluetooth connectivity to smartphones. Christiansen et al 32 reported that this new device shows analytical and clinical accuracy and is easy to use in clinical settings among patients who have never used blood glucose monitoring devices previously.…”

Section: Perspectives and Concluding Remarksmentioning

confidence: 99%

Disruption in the diabetic device care market

Ojha

Mohammed

2018

MDER

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As diabetes mellitus (DM) has approached pandemic proportions, the pressure for effective glycemic management is mounting. The starting point for managing and living well with DM involves early diagnosis and monitoring blood glucose levels. Therefore, self-monitoring of blood glucose (SMBG) can help patients maintain their blood glucose levels within the appropriate range. The general principle behind the current SMBG method involves a finger prick test to obtain a blood drop, which is applied onto a reagent strip and read by an automated device. Novel techniques are currently under evaluation to create the next generation of painless and accurate glucose monitoring for DM. We began by outlining how the emerging technology of the noninvasive glucose monitoring devices (NIGMDs) provides both economic and clinical benefits for health systems and patients. We further explored the engineering and techniques behind these upcoming devices. Finally, we evaluated how the NIGMDs disrupt the diabetic device care market and drive health care consumerism. We postulated that the NIGMDs play a pivotal role in the implementation of next generation of diabetes prevention strategies.

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A New, Wireless-enabled Blood Glucose Monitoring System That Links to a Smart Mobile Device: Accuracy and User Performance Evaluation

Abstract: The BGMS exceeded ISO 15197:2013 accuracy criteria in the laboratory and in a clinical setting.

Cited by 25 publications

References 12 publications

User Performance Evaluation of Four Blood Glucose Monitoring Systems Applying ISO 15197:2013 Accuracy Criteria and Calculation of Insulin Dosing Errors

User Performance Evaluation of Four Blood Glucose Monitoring Systems Applying ISO 15197:2013 Accuracy Criteria and Calculation of Insulin Dosing Errors

Assessment of System Accuracy, Intermediate Measurement Precision, and Measurement Repeatability of a Blood Glucose Monitoring System Based on ISO 15197

Disruption in the diabetic device care market

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