Method Comparison/User Evaluation of the i-SENS Self-Monitoring Blood Glucose / β-Ketone System

Glucose Testing of Subject Plasma Samples

The subject capillary plasma samples will be tested in duplicate. If the average of replicates 1\&2 do not fall within range (within 4% for readingsabove100mg/dL or 4 mg/dL for samples less than or equal to 100mg/dL) the sample will be run a third time and the 2 average replicate readings that fall within range (4% for readings above 100mg/dL or 4 mg/dL for samples less than or equal to 100mg/dL) will be recorded as evaluable. In general, duplicates will be averaged for each subject. If the sample is insufficient or missing and have only a single YSI value, it will be used as the YSI determination. If none of the 3 average replicates fall within (4% for readings above 100mg/dL or 4 mg/dL for samples less than or equal to 100mg/dL) will be recorded as non-evaluable. If the YSI autocals between subject sample duplicates, then another YSI 2747 standard will be run before completing the subject sample cycle.

Time frame: Within 20 minuates of centrifugation

β-Ketone Testing of Subject Plasma Samples

The subject capillary plasma sample will be tested in duplicate using Rx Imola analyzer. If the measured values differ by \> 0.075 mmol/L at ketone \< 1.5 mmol/L or \> 5% at ketone ≥ 1.5 mmol/L, the sample will be run a third time and the 2 average replicate readings that fall within range will be recorded as evaluable. In general, duplicates will be averaged for each subject. If the sample is insufficient or missing and has only a single Rx Imola value, it will be used as the Rx Imola determination. If none of the 3 average replicates fall within \> 0.075 mmol/L at ketone \< 1.5 mmol/L or \> 5% at ketone ≥ 1.5 mmol/L for readings, it will be recorded as non-evaluable.