Abbott FreeStyle Libre 3 User Manual

Sensor Accuracy Over Time
The Sensor can be worn for up to 14 days. The percentage of System readings
within YSI values and the Mean Absolute Relative Difference (MARD) is presented
for the following different wear periods in Tables 6a and 6b: Beginning (Adult: 198
Subjects, Day 1, 2 or 3; Pediatric: 75 Subjects, Day 1, 2 or 3) Early Middle (Adult: 124
Subjects, Day 7 or 8; Pediatric: 63 Subjects, Day 7 or 8), Late Middle (Adult: 86
Subjects, Day 9 or 12; Pediatric: 67 Subjects, Day 9 or 12), and End (Adult: 97
Subjects, Day 13 or 14; Pediatric: 64 Subjects, Day 13 or 14). For values 70 mg/dL
and above, the percentage of readings within 15%, 20%, and 40% of the YSI value
was calculated. For values below 70 mg/dL, the percentage of readings within
15 mg/dL, 20 mg/dL, and 40 mg/dL of the YSI value was calculated.
Table 6a: Sensor Accuracy Relative to YSI over the wear duration (Adult;
n=200)
Table 6b: Sensor Accuracy Relative to YSI over the wear duration (Pediatric*;
n=168)
* Includes children 6-17 years of age. No YSI measurements were obtained for children 4-5 years of age.
Sensor Wear Duration
The Sensor can be worn for up to 14 days. To estimate how long a Sensor will work
over the wear duration, 101 Sensors were evaluated to determine how many days
of readings each Sensor provided. Of the 101 Sensors, 68.3% lasted until the final
DOC44383_rev-C 1:14pm 22-SEP-2021

Abbott FreeStyle Libre 3 Specifications

General

Sensor Type	Continuous Glucose Monitoring (CGM)
Sensor Wear Duration	14 days
Connectivity	Bluetooth
App Compatibility	FreeStyle Libre 3 app (iOS and Android)
Data Update Frequency	Every minute
Warm-up Time	60 minutes
Accuracy	MARD (Mean Absolute Relative Difference) of 7.9%
Calibration	Factory calibrated
Battery Life	Sensor lasts for 14 days, no battery replacement required
Data Storage	8 hours of data stored on the sensor
Alerts	High and low glucose alerts
Measurement Range	40 to 400 mg/dL (2.2 to 22.2 mmol/L)