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  • Title: Accuracy of a portable glucose meter and of a Continuous Glucose Monitoring device used at home by patients with type 1 diabetes.
    Author: Francescato MP, Geat M, Stel G, Cauci S.
    Journal: Clin Chim Acta; 2012 Jan 18; 413(1-2):312-8. PubMed ID: 22032826.
    Abstract:
    BACKGROUND: Patients with diabetes are recommended to self-monitor their blood glucose levels also at home. Accuracy of a hand-held glucometer and a Continuous Glucose Monitoring (CGM) device were comparatively evaluated. METHODS: Venous blood samples (for reference laboratory determinations; n=428) were collected from 18 type 1 patients (35-65 years old), immediately followed by capillary measurement (Bayer ContourLink meter) and CGM readings (Medtronic Paradigm). RESULTS: Laboratory values did not differ statistically from ContourLink and CGM readings, mean difference (±SD) being -0.05±1.06 mmol/L and 0.10±1.84 mmol/L glucose, respectively. A bias ((value-reference)/reference×100) ≥15% was observed in 27.7% and 54.9% of cases, respectively. Notably, below 3.9 mmol/L glucose (hypoglycemic threshold), an absolute error>0.8 mmol/L was found in 78.9% and 94.1% of cases. The absolute errors of the CGM device were inversely related to the rate of glucose change (r=0.598, p<0.001). CONCLUSIONS: A very large error was observed at the extreme glycemic values, which may lead to erroneous therapy. Consequently, performance of future portable glucometers should be focused in particular under hypo- and hyper-glycemia. Moreover, integrated CGM devices should not disregard the effect of the rate of blood glucose change on the sensor readings.
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