ArticleJournal of diabetes science and technology2018
Evaluation of Hematocrit Influence on Self-Monitoring of Blood Glucose Based on ISO 15197:2013: Comparison of a Novel System With Five Systems With Different Hematocrit Ranges.
Article in Journal of diabetes science and technology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
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3 citing papers in PubMed.
- 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
- Comparative Accuracy Evaluation of a Blood Glucose Meter With Novel Hematocrit Correction Technology, With Three Currently Used Commercially Available Blood Glucose Monitoring Systems.Journal of diabetes science and technology · 2019Article
- Evaluation of Hematocrit Influence on Measurements With a Novel Self-Monitoring of Blood Glucose System Based on ISO 15197:2013.Journal of diabetes science and technology · 2018Article
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2 authors.
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Abstract
introductionISO 15197:2013 recommends testing procedures and acceptance criteria for the evaluation of influence quantities such as hematocrit on measurement results with systems for self-monitoring of blood glucose (SMBG). In this study, hematocrit influence was evaluated for a novel SMBG system (system A) and five other systems with different hematocrit ranges based on ISO 15197:2013.
methodsTest procedures were performed with one test strip lot for each system. Each system was tested within the hematocrit range indicated in the manufacturer's labeling (system A: 10-65%, B: 15-65%, C: 20-60%, D: 35-60%, E: 30-60%, F: 30-55%). According to ISO 15197:2013, clause 6.4.2, venous blood samples were used for the evaluation of hematocrit influence. The evaluation was performed for three glucose concentration categories (30-50 mg/dL, 96-144 mg/dL, and 280-420 mg/dL). For each glucose concentration category, at least five different hematocrit levels were investigated.
resultsThe novel system A and systems B, E, and F complied with the tested lot with the defined criteria and showed ≤10 mg/dL and ≤10% difference between the test sample and the respective control sample with a hematocrit value of 42% ± 2% for BG concentrations <100 mg/dL and ≥100 mg/dL, respectively. Two systems showed >10% difference at glucose concentrations ≥100 mg/dL.
conclusionsRemarkable hematocrit influence within the labeled hematocrit range was obtained in two systems with the tested reagent system lot. Adequate SMBG systems should be carefully chosen by patients and their health care professionals, particularly for patients with increased and decreased hematocrit values.
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