ArticleBMJ open diabetes research & care2020
System accuracy evaluation of 18 CE-marked current-generation blood glucose monitoring systems based on EN ISO 15197:2015.
Article in BMJ open diabetes research & care, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03737188 (Institut Fuer Diabetes-Technologie Surveillance Program for Blood Glucose Monitoring Systems in Europe), which is not on this map. Cited by 23 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Institut Fuer Diabetes-Technologie Surveillance Program for Blood Glucose Monitoring Systems in Europe
Who cites it
23 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Effects of carotenoid supplementation on glycemic control: a systematic review and meta-analysis of randomized clinical trials.European journal of clinical nutrition · 2025Pooled it
- Laser-Assisted Self-Monitoring of Blood Glucose: Analytical Performance, Clinical Accuracy, and Usability of the HandyRay-Glu System.Diagnostics (Basel, Switzerland) · 2026Article
- 7. Diabetes Technology: Standards of Care in Diabetes-2026.Diabetes care · 2026Review
- Residual Safety Margin-Based Risk Stratification for Hospital-Wide POCT Glucose Meters Anchored to ISO 15197: Moving Beyond Pass-Fail.Diagnostics (Basel, Switzerland) · 2025Article
- Choosing wisely: Improving decision-making for deployment of diagnostics in primary care settings.Journal of family medicine and primary care · 2025Article
- Accuracy validation and user performance analysis of two new self-monitoring blood glucose systems.Endocrinology, diabetes & metabolism case reports · 2025Article
- Monitoring of the Analytical Performance of Four Different Blood Glucose Monitoring Systems: A Post-market Performance Follow-Up Study.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2024Article
- User Performance Evaluation and System Accuracy Assessment of Four Blood Glucose Monitoring Systems With Color Coding of Measurement Results.Journal of diabetes science and technology · 2024Article
- Society for Endocrinology guidelines for the diagnosis and management of post-bariatric hypoglycaemia.Endocrine connections · 2024Review
- Improving the Bias of Comparator Methods in Analytical Performance Assessments Through Recalibration.Journal of diabetes science and technology · 2024Article
- Quality assessment of glucose measurement with regard to epidemiology and clinical management of diabetes mellitus in Germany.Frontiers in molecular biosciences · 2024Article
- Blood glucose monitoring devices: current considerations.Australian prescriber · 2023Review
- Impact of Blood Glucose Monitoring System Accuracy on Clinical Decision Making for Diabetes Management.Journal of diabetes science and technology · 2023Article
- Updated Post-Market Surveillance of the Clinical Accuracy of a Blood Glucose Test Strip Platform.Journal of diabetes science and technology · 2023Article
- 7. Diabetes Technology: Standards of Care in Diabetes-2023.Diabetes care · 2023Review
- Mean Absolute Relative Difference of Blood Glucose Monitoring Systems and Relationship to ISO 15197.Journal of diabetes science and technology · 2022Article
- Impact of Two Different Reference Measurement Procedures on Apparent System Accuracy of 18 CE-Marked Current-Generation Blood Glucose Monitoring Systems.Journal of diabetes science and technology · 2022Article
- Do We Need the Replacement of YSI 2300? A View from the Clinical Laboratory.Journal of diabetes science and technology · 2022Article
- Self-Monitoring of Blood Glucose as an Integral Part in the Management of People with Type 2 Diabetes Mellitus.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2022Article
- Glucose biosensors in clinical practice: principles, limits and perspectives of currently used devices.Theranostics · 2022Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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 NUMBER: NCT03737188.
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