Detection of Low Glucose

Section 18 161

Appendix B: Specifications

18 Appendix B: Specifications (con’t)

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	Day True	Day Missed	Day False	Night True	Night Missed	Night False
Setting (mg/dL)	Alarms*	Alarms**	Alarms***	Alarms*	Alarms**	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	Day True	Day Missed	Day False	Night True	Night Missed	Night False
Setting (mg/dL	Alarms*	Alarms**	Alarms*	Alarms**	Alarms***	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 percentage of time an alarm occurred but the glucose level was not above the threshold setting.

†n/N is the (n)umber of observations divided by the total (N)umber.

OVER

PRT03831-xxx specifications

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Arkon PRT03831-xxx manual Detection of Low Glucose

Models: PRT03831-xxx

18 Appendix B: Specifications (con’t)