Determination of Alarm Performance

160

Section 18

Appendix B: Specifications

18 Appendix B: Specifications (con’t)

The threshold alarm is characterized below. The projected alarm performance has not been established.

The performance of low and high glucose alarms was assessed in an in-clinic study using 58 subjects with type 1 diabetes wearing one FreeStyle Navigator sensor on the arm and one sensor on the abdomen. FreeStyle Navigator continuous data were masked from the subjects and investigators and the alarms were not turned on. During 50 hours the subjects’ venous glucose was tested with a YSI 2300 Stat Plus glucose analyzer at 15 minute intervals. Arm and abdomen data were pooled in the alarm analysis. Alarm performance was evaluated in a retrospective analysis of the study data. As alarm performance was developed retrospectively, your results may vary from those reported below.

Definitions:

Hypoglycemic event – two or more successive YSI measurements below the alarm threshold or one YSI measurement 6 mg/dL below the alarm threshold.

Hyperglycemic event – two or more successive YSI measurements above the alarm threshold or one YSI measurement 6% above the alarm threshold.

True Threshold Alarm – a threshold alarm that occurred ± 30 minutes from the start of a hypoglycemic or hyperglycemic event

True Alarm Rate – the percentage of time the glucose level was beyond the threshold and an alarm was activated

	Events Detected by True Threshold Alarms	X 100
	Total Events	X 100
	Total Events

Missed Alarm Rate – the percentage of time the glucose level was beyond the threshold and an alarm was not activated

	Events Not Detected by True Threshold Alarms	X 100
	Total Events	X 100
	Total Events

False Threshold Alarm – a threshold alarm that occurred when a YSI measurement within ± 30 minutes was not beyond the threshold setting

False Alarm Rate – the percentage of time an alarm occurred when glucose level was not beyond the threshold setting

	False Threshold Alarms	X 100
	Total Threshold Alarms	X 100
	Total Threshold Alarms

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PRT03831-xxx specifications

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Arkon PRT03831-xxx manual Determination of Alarm Performance, Definitions

Models: PRT03831-xxx

18 Appendix B: Specifications (con’t)