18 appendix b: specifications, Detection of low glucose, Detection of high glucose – Abbott Freestyle PRT03831-xxx User Manual
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18 Appendix B: Specifications
(con’t)
Detection of Low Glucose
See Table 7 below for detection of low glucose. As an example, when the threshold alarm was set at 70 mg/dL
(during the day), 56 % of the low glucose events were detected by FreeStyle Navigator.
Table 7. Low Glucose Detection
DAY
NIGHT
Low Alarm
Setting (mg/dL)
Day True
Alarms*
Day Missed
Alarms**
Day False
Alarms***
Night True
Alarms*
Night Missed
Alarms**
Night False
Alarms***
% (n/N
†
)
% (n/N)
% (n/N)
% (n/N)
% (n/N)
% (n/N)
65
46 (56/121)
54 (65/121)
19 (18/95)
80 (12/15)
20 (3/15)
41 (11/27)
70
56 (98/176)
44 (78/176)
16 (21/132)
79 (19/24)
21 (5/24)
40 (14/35)
75
59 (130/219)
41 (89/219)
9 (15/161)
72 (23/32)
28 (9/32)
37 (14/38)
85
61 (189/308)
39 (119/308)
7 (17/228)
65 (22/34)
35 (12/34)
33 (14/43)
* True Alarms are the percentage of time the glucose level was below the threshold and an alarm was activated.
** Missed Alarms are the percentage of time the glucose level was below the threshold and an alarm was not activated.
*** False Alarms are the percentage of time an alarm occurred but the glucose level was not below the threshold setting.
†
n/N is the (n)umber of observations divided by the total (N)umber.
Detection of High Glucose
See Table 8 for detection of high glucose. As an example, when the threshold alarm was set at 240 mg/dL
(during the day), 78 % of the high glucose events were detected by FreeStyle Navigator.
Table 8. High Glucose Detection
DAY
NIGHT
High Alarm
Setting (mg/dL
Day True
Alarms*
Day Missed
Alarms**
Day False
Alarms*
Night True
Alarms**
Night Missed
Alarms***
Night False
Alarms***
% (n/N
†
)
% (n/N)
% (n/N)
% (n/N)
% (n/N)
% (n/N)
180
89 (561/630)
11 (69/630)
11 (68/628)
69 (29/42)
31 (13/42)
7 (3/44)
240
78 (295/376)
22 (81/376)
12 (47/393)
41 (12/29)
59 (17/29)
25 (7/28)
270
70 (193/274)
30 (81/274)
12 (32/265)
21 (3/14)
79 (11/14)
36 (5/14)
300
61 (117/192)
39 (75/192)
12 (20/161)
12 (1/8)
88 (7/8)
33 (1/3)
* True Alarms are the
percentage of time the glucose level was above the threshold and an alarm was activated.
** Missed Alarms are the percentage of time the glucose level was above the threshold and an alarm was not activated.
*** False Alarms are the pe
rcentage of time an alarm occurred but the glucose level was not above the threshold setting.
†
n/N is th
e (n)um
ber of observations divided by the total (N)umber
.
Section 18
161
Appendix B: Specifications