Dexcom G4 Professional User's Guide download pdf (Page 184)

184 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System

Participants used the System for seven days. Thirty-six participants

each wore 2 sensors. Sensors were calibrated approximately once

every 12 hours, using the self-monitoring blood glucose (SMBG)

meter values obtained from the LifeScan

OneTouch

Ultra

2 meter.

Throughout the 7-day wear period, the sensor was calibrated with an

averageof2ngersticksperday(approximatelyonceevery12hours).

All subjects were evaluated in a controlled clinic environment on Day

1, Day 4, and Day 7 of the 7-day wear period. While using the System

in the clinic, participants had their blood glucose measured every 15

minutes with a reliable laboratory method, the Yellow Springs Instrument

2300 STAT Plus™ Glucose Analyzer. This instrument is referred to as

the “YSI.” Readings from the System were reported every 5 minutes

and paired with YSI values in order to characterize how well the System

readings agreed with laboratory standard blood glucose results. The

remainder of the study took place at home, the System performance

was also paired with the comparative LifeScan OneTouch Ultra 2 meter

results, and that is referred to as the ‘SMBG’.

Agreement

Agreement between the System and blood glucose values is

characterized using paired System and YSI values. The System and

YSI results were compared by pairing the YSI blood glucose value to

a System glucose reading that occurred immediately after the YSI was

collected.

The agreement of the System to blood glucose value was assessed by

calculatingthepercentageofSystemreadingsthatwerewithin15%,

20%,30%,40%andgreaterthan40%oftheYSIvalues.Forreadings

less than or equal to 80 mg/dL (4.4 mmol/L) the absolute difference

in mg/dL (mmol/L) between the two glucose results was calculated.

For values greater than 80 mg/dL (4.4 mmol/L) the absolute percent

difference(%)fromtheYSIvalueswascalculated.Thepercentages

oftotalreadingswithin15mg/dL(0.8mmol/L)or15%,20mg/dL(1.1

mmol/L)or20%,30mg/dL(1.7mmol/L)or30%,40mg/dL(2.2mmol/L)

or40%orgreaterthan40mg/dL(2.2mmol/L)or40%werethen

calculated in Table 1-A and Table 1-B.

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Dexcom G4 Professional User's Guide Page 184