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Validity and reliability of a handheld blood glucose monitor during exercise and an oral glucose tolerance test

The purpose of the present study was
to examine the validity and reliability of the handheld Nova Max Plus blood
glucose monitor during an oral glucose tolerance test and 60-minute bout of
exercise. Thirty subjects (mean age±SD=22.3±1.9 years; body mass=77.6±14.2 kg)
volunteered for an oral glucose tolerance test or 60-minute treadmill test. Blood
glucose concentrations were measured from the fingertip at six time points
during both tests. The reference method of blood glucose analysis was the
Yellow Springs Instruments (YSI) 2300. Our results indicated that the blood
glucose values provided by the Nova Max Plus were significantly (p<.05) greater
than the YSI 2300 at all-time points of the oral glucose tolerance test and
treadmill test. In addition, the Nova Max Plus exhibited an overall mean
absolute relative deviation (±SD) of 9.0 (±7.0) and did not meet the 95% accuracy
requirements of ISO 15197:2013. The Bland-Altman plot for constant error (YSI
2300 – Nova Max Plus) versus the reference method (YSI 2300) indicated an
average negative bias (-8.2 mg·dL-1) that increased (r=-0.23)
at higher blood glucose values. Intra-device reliability analyses for the Nova
Max Plus demonstrated the ICC was R=0.99
and CV=3.0%, with no mean differences between the test and retest values. These
findings suggested that the Nova Max Plus provided highly reliable, yet
inaccurate blood glucose values compared to the YSI 2300 during the dynamic
conditions associated with an oral glucose tolerance test and exercise.