User Guide CGM
Attachment D Technical Information 78
• Potential for improved quality of life
■ Decreased ngerstick testing, Increased ease of glucose
monitoring
■ Decreased manual record keeping
■ Increased ability to identify and treat hypoglycemia;
■ Increased reassurance for those fearful of hypoglycemia during
sleep, sports, driving etc
• Reduced limitations of ngerstick blood glucose tests:
■ CGM overcomes some limitations of ngerstick blood glucose
monitoring include: inconvenience; physical intrusiveness of
"poking" multiple times daily; limited single “point-in-time” glucose
measurement; missed data (between meals, overnight, with sports
or with asymptomatic hypo/hyperglycemia).
■ CGM provides real-time blood glucose readings throughout the
day, using the device as close to daily as possible could provide
real-time, dynamic glucose information, increase tighter glycemic
control and result in fast, proactive response, therefore enable
maximal clinical benet to the user.
D.2. Product Specications
Sensor
Sensor glucose assay method
Amperometric electrochemical sensor
Sensor glucose result range
36.0 mg/dL – 450.0 mg/dL (2.0–25.0 mmol/L)
Sensor life
Up to 15 days
Shelf life
Up to 1 year
Storage and transport temperature
2°C to 30°C (36°F to 86°F)
Storage and transport humidity
10% - 90% Relative humidity
Operating temperature
10°C to 42°C (50°F to 108°F)
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