Repeatability: N=300
Intermediate Precision: N=1000
Consumer Study
TRUEbalance was tested at diabetes clinics of a large urban area
hospital and diabetes care centers. TRUEbalance results were obtained
from 212 patients and were compared to parallel results obtained on
Yellow Springs Model 2300 STAT. This study shows that patients, when
self-testing, and laboratory professionals are able to obtain accurate
results when compared to results obtained from a laboratory system.
A clinical study was performed at an urban area hospital to compare
forearm and finger stick blood glucose results using the TRUEbalance.
TRUEbalance blood glucose tests were performed by patients self-
testing (n=100) and on patients’ blood by healthcare professionals
(n=108). Results demonstrate substantial equivalence between forearm
and finger blood glucose values when patients’ blood glucose is in
steady state and blood glucose tests are performed by patients or
healthcare professionals using the TRUEbalance.
36
Mean (mmol/L) 2.4 5.6 7.5 13.0 19.6
Mean (mg/dL) 43 100 135 234 354
SD (mmol/L)
0.14 0.17 0.23 0.47 0.68
SD (mg/dL)
2.5 3.0 4.1 8.5 12.2
CV%
6.8 3.3 3.2 3.9 3.4
Mean (mmol/L) 2.2 5.5 15.7
Mean (mg/dL) 38.7 98.2 283.5
SD (mmol/L)
0.21 0.26 0.59
SD (mg/dL)
3.7 4.6 10.6
CV%
9.5 4.7 3.7
TB_OB_GutsENG_H4IAU03.qxd:TT_OB_GutsENG.qxd 10/13/10 12:33 PM Page 36
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