OBJECTIVE - To evaluate the accuracy, comfort, and ease of use of a new aut
omated device for blood glucose monitoring using the arm as an alternative
sampling site.
RESEARCH DESIGN AND METHODS- These studies use an automated hand-held devic
e that applies a small vacuum, lances the skin, transfers blood onto an ele
ctrochemical test strip, and measures glucose. Patients who had type 1 or t
ype 2 diabetes and had received no prior training using this device were re
cruited from five diabetes clinics. Testing was performed by the patients u
sing this device and by trained healthcare professionals. Blood glucose was
measured by 354 patients: from the arm using the device, from the finger u
sing a laboratory reference instrument, and from the finger using the devic
e via the secondary test port. Each patient completed a questionnaire ratin
g the level of pain and ease of use of the device.
RESULTS - Blood glucose results in samples obtained from the arm with the a
utomated device agreed well with finger stick plasma glucose results using
a reference instrument (regression slope 0.98, intercept 0.01 mmol/l [0.1 m
g/dl], r = 0.96). Error grid analysis showed that 100% of the measurements
fell within zones A and B. In the survey, 60% of the patients reported that
arm testing with the automated device was "painless;" another 31% of the p
atients stated that it was "much less painful," and 6% of patients consider
ed using the device "less painful" than finger-stick testing. In a survey c
ontaining 15 questions for rating the ease of use with a scale of 1 to 6, t
he overall mean rating was 5.5.
CONCLUSIONS- The automated device is easy to use and provides accurate gluc
ose results; 97% of the patients found it less painful than finger-stick te
sting.