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System accuracy evaluation of 18 CE-marked current-generation blood glucose monitoring systems based on EN ISO 15197:2015
  1. Stefan Pleus,
  2. Annette Baumstark,
  3. Nina Jendrike,
  4. Jochen Mende,
  5. Manuela Link,
  6. Eva Zschornack,
  7. Cornelia Haug,
  8. Guido Freckmann
  1. Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH, Universität Ulm, Ulm, Germany
  1. Correspondence to Stefan Pleus; stefan.pleus{at}idt-ulm.de

Abstract

Objective Accuracy 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 methods The 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.

Results In 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%.

Conclusions This 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 number NCT03737188.

  • accuracy
  • blood glucose monitors
  • blood glucose self-monitoring
  • health care research
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Footnotes

  • Contributors SP substantially contributed to conception and design, analysis, interpretation of data, critically reviewed the article, and gave final approval for the article. AB substantially contributed to conception and design, interpretation of data, critically reviewed the article, and gave final approval for the article. NJ substantially contributed to conception and design, acquisition of data, interpretation of data, critically reviewed the article, and gave final approval for the article. JM substantially contributed to conception and design, analysis, interpretation of data, drafted the article, and gave final approval for the article. ML substantially contributed to acquisition of data, critically reviewed the article, and gave final approval for the article. EZ substantially contributed to acquisition of data, critically reviewed the article, and gave final approval for the article. CH substantially contributed to conception and design, interpretation of data, critically reviewed the article, and gave final approval for the article. GF substantially contributed to conception and design, interpretation of data, critically reviewed the article, and gave final approval for the article. All authors take responsibility for the decision to submit and publish the manuscript.

  • Funding This study was funded by Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Germany; LifeScan Scotland Limited, UK; Ascensia Diabetes Care Deutschland GmbH, Germany; Roche Diabetes Care GmbH, Germany; i-SENS GmbH, Germany; Beurer GmbH, Germany; AgaMatrix Europe Limited, UK. Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Germany (IDT) was responsible for study design, data collection, evaluation of results, and preparation of this article. No other funding parties were involved in study design; collection, analysis, and interpretation of data; writing the report; or the decision to submit the report for publication.

  • Competing interests GF is general manager of the IDT, which carries out clinical studies on the evaluation of BG meters and medical devices for diabetes therapy on its own initiative and on behalf of various companies. GF/IDT have received speakers’ honoraria or consulting fees from Abbott, Ascensia, Dexcom, LifeScan, Menarini Diagnostics, Metronom Health, Novo Nordisk, Roche, Sanofi, Sensile, and Ypsomed. SP, AB, NJ, JM, ML, EZ, and CH are employees of IDT; no competing financial interests exist.

  • Patient consent for publication Obtained.

  • Ethics approval The study protocol was part of a study series approved by the responsible Ethics Committee (“Ethikkommission bei der Landesärztekammer Baden-Württemberg”, ethics committee at the state chamber of medicine in Baden-Württemberg), approval number MP-2015-009, and exempted from approval by the German Federal Institute for Drugs and Medical Devices (BfArM).

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement No data are available. Individual, deidentified participant data will not be shared.

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