Bolus Insulin Dose Error Distributions Based on Results From Two Clinical Trials Comparing Blood Glucose Monitoring Systems

Pardo, Scott; Dunne, Nancy; Simmons, David A.

doi:10.1177/1932296817713025

Cited by 4 publications

(2 citation statements)

References 14 publications

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“…However, using only well performing devices for glucose measurement is of particular importance for clinical trials as confirmed in recently published studies. 16,17 Obviously, good device accuracy is a prerequisite to ensure patient safety. However, a suboptimal device performance may lead to other study-related problems such as potential bias in endpoints, potential inconsistencies between SMBG values and HbA1c, and so forth.…”

Section: Discussionmentioning

confidence: 99%

Laboratory Evaluation of Linearity, Repeatability, and Hematocrit Interference With an Internet-Enabled Blood Glucose Meter

Demircik¹,

Kirsch

Ramljak³

et al. 2019

J Diabetes Sci Technol

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Background: In recent clinical trials, use of the MyGlucoHealth blood glucose meter (BGM) and electronic diary was associated with an unusual reporting pattern of glycemic data and hypoglycemic events. Therefore, the performance of representative BGMs used by the patients was investigated to assess repeatability, linearity, and hematocrit interference in accordance with regulatory guidelines. Method: Ten devices and 6 strip lots were selected using standard randomization and repeatability procedures. Venous heparinized blood was drawn from healthy subjects, immediately aliquoted and adjusted to 5 target blood glucose (BG) ranges for the repeatability and 11 BG concentrations for the linearity tests. For the hematocrit interference test, each sample within 5 target BG ranges was split into 5 aliquots and adjusted to hematocrit levels across the acceptance range. YSI 2300 STAT Plus was used as the laboratory reference method in all experiments. Results: Measurement repeatability or precision was acceptable across the target BG ranges for all devices and strip lots with coefficient of variation (CV) between 3.4-9.7% (mean: 5.7%). Linearity was shown by a correlation coefficient of .991; however, a positive bias was seen for BG <100 mg/dL (86% measurements did not meet ISO15197:2015 acceptance criteria). Significant hematocrit interference (up to 20%) was observed for BG >100 mg/dL (ISO15197:2015 acceptance criteria: ±10%), while the results were acceptable for BG <100 mg/dL. Conclusions: The BGM met repeatability requirements but demonstrated a significant measurement bias in the low BG range. In addition, it failed the ISO15197:2015 criteria for hematocrit interference.

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Section: Discussionmentioning

confidence: 99%

Laboratory Evaluation of Linearity, Repeatability, and Hematocrit Interference With an Internet-Enabled Blood Glucose Meter

Demircik¹,

Kirsch

Ramljak³

et al. 2019

J Diabetes Sci Technol

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“…Accurate SMBG measurement results are crucial for adequate insulin dosing decisions by patients on insulin therapy. Modelling analyses showed that inaccurate BG measurements can lead to insulin dosing errors [ 1 , 3 , 4 , 39 , 40 ] which can adversely affect glycemic control and increase the risk of long-term complications in patients on intensive insulin therapy. In this study, negative median insulin dosing errors (too small insulin doses) were calculated for three systems (A, B, D) and positive median insulin dosing errors (too high insulin doses) were calculated for one system (C).…”

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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Accuracy of five systems for self-monitoring of blood glucose in the hands of adult lay-users and professionals applying ISO 15197:2013 accuracy criteria and potential insulin dosing errors

Jendrike

Baumstark

Pleus

et al. 2018

Current Medical Research and Opinion

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Bolus Insulin Dose Error Distributions Based on Results From Two Clinical Trials Comparing Blood Glucose Monitoring Systems

Abstract: The ranges of insulin dose errors were statistically significantly smaller with EZ and CN than with all other BGMSs in this post hoc analysis. Differences in BGMS accuracy could result in clinically important differences in insulin dosing.

Cited by 4 publications

References 14 publications

Laboratory Evaluation of Linearity, Repeatability, and Hematocrit Interference With an Internet-Enabled Blood Glucose Meter

Laboratory Evaluation of Linearity, Repeatability, and Hematocrit Interference With an Internet-Enabled Blood Glucose Meter

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

Accuracy of five systems for self-monitoring of blood glucose in the hands of adult lay-users and professionals applying ISO 15197:2013 accuracy criteria and potential insulin dosing errors

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