Dexcom stelo Manual page 98

Concurrence of Stelo Glucose Biosensor and comparator
method
Table 2 describes (column percent), for each range of YSI values, what percentage of
paired Biosensor readings was in the same glucose range (shaded) or in glucose
ranges above and below the paired YSI values. For example, Table 2 shows that when
YSI values are within 70 to 120 mg/dL, you can expect your Biosensor readings to be
within 70 to 120 mg/dL 85.1% of the time.
Table 2. Concurrence of Biosensor readings and YSI values by YSI Glucose
Range (n=130)
Biosensor Glucose Range (mg/dL)
(Column %)
<70
70–120
121–160
161–200
201–250
>250
Total
1
Biosensor readings are within 40-400 mg/dL, inclusive.
92
Comparator Glucose Values (mg/dL)
<70 70–120
1,432 410
(72.9%) (6.9%) (0.0%)
532 5,029
(27.1%) (85.1%) (14.7%)
469
---
(7.9%) (75.0%)
3
---
(0.1%) (10.2%)
--- ---
--- ---
1,964 5,911
121– 161– 201–
160 200
1
---
506 13
(0.6%) (0.0%)
2,584 468
(21.5%) (1.1%)
353 1,487
(68.5%) (22.2%)
1 204 1,350
(0.0%) (9.4%) (67.4%)
--- ---
(9.2%)
3,445 2,172 2,003
>250
250
--- ---
1 3
(0.1%)
23 3
(0.1%)
444 33
(0.7%)
697
(14.1%)
185 4,196
(85.1%)
4,932