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ART05005-REV-4

Appendix A: Clinical Study for Palm and Finger Test

A clinical study was conducted to compare glucose readings using blood from the

finger and blood from the palm at the base of the thumb. Forty-one subjects with

type 1 diabetes were given a glucose challenge to raise glucose to a hyperglycemic

state and then given subcutaneous insulin to reduce glucose to a normal or

hypoglycemic state. The differences between readings from the finger and palm at

the base of the thumb sites for all glucose levels and for low glucose levels are

summarized below.

Table A.1. Clinical Trial Glucose Readings

Range

Number of

Test Pairs

Average

Difference

Standard

Deviation

All Tests

43-477 mg/dL

(2.4-26.5 mmol/L)

1309 -2.1% 12.7%

Low Glucose

43-69 mg/dL

(2.4-3.8 mmol/L)

1.9 mg/dL

(0.3 mmol/L)

9.0 mg/dL

(0.5 mmol/L)