M P Francescato1, M Geat, G Stel, S Cauci. 1. Department of Medical and Biological Sciences, School of Medicine, University of Udine, Udine, Italy. maria.francescato@uniud.it
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.
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.
Authors: Ruth S Weinstock; Suzan Bristol; Andrew Armenia; A Chris Gesswein; B Wayne Bequette; John P Willis Journal: J Diabetes Sci Technol Date: 2012-11-01