FreeStyle Mini blood glucose results are accurate and suitable for use in glycemic clamp protocols.
OBJECTIVE
We assessed the accuracy of the FreeStyle Mini (FSM) meter for use in glycemic clamp and meal protocols in comparison with the HemoCue Glucose 201 DM Analyzer (HemoCue) and the YSI 2300 STAT Glucose Oxidase Analyzer (YSI).


METHODS
Seven volunteers with type 2 diabetes mellitus, 35-69 years old, underwent a frequently sampled meal test and a graded hyperglycemic test, on two separate days, with one of the volunteers undergoing each test twice. Samples for glucose measurements were obtained from arterialized venous blood. A total of 420 samples (with glucose levels ranging from 63 to 388 mg/dl) were available for comparison. On average, 10 measurements were available for every 5 mg/dl increment in glucose level in the range of 130-310 mg/dl. Blood glucose measurements were done on each sample with the FSM, HemoCue, and YSI.


RESULTS
FreeStyle Mini blood glucose values correlated closely with the YSI readings. Of the FSM measurements, 99.0% were within the Clarke error grid zone A; 51.3%, 84.7%, and 96.2% of the FSM readings were within 5%, 10% and 15% of the YSI values, respectively. The FSM was significantly more accurate than the HemoCue (84.7% vs 76.6% of results within 10% of the YSI results; p = .0038). The mean average relative difference of the FSM (5.8%) was also significantly lower than that of the HemoCue (6.8%; p = .0013)


CONCLUSIONS
The FSM provides accurate results and constitutes a suitable alternative for bedside blood glucose measurements in experimental procedures, helping to reduce sample size, turnaround time, and cost.
Cohen
Ohad
O
Institute of Endocrinology, Ch. Sheba Medical Center, Sackler School of Medicine, Tel Aviv University, Israel. ohad.cohen@sheba.health.gov.il
Shaklai
Sigal
S
Gabis
Ephraim
E
Pani
Michael A
MA