CGM continuous glucose monitoring system FreeStyle Libre 3

with subcutaneous sensorsmartphone-basedpatch

Overview
The FreeStyle Libre 3 system is a continuous glucose monitoring (CGM) system comprising patient‑applied sensors (FreeStyle Libre 3 Plus and Libre 3 options) and the Libre app. It streams real-time glucose readings to compatible smartphones and provides on-demand readings for clinical and self‑management use.

Key product information
The FreeStyle Libre 3 Plus sensor is a 15‑day, patient‑applied sensor designed for application to the back of the upper arm. The sensor requires a 60‑minute warm-up after insertion and streams glucose values directly to a compatible mobile device when used with the Libre app. The system supports optional audible and/or visual alarms for high and low glucose notifications.

Clinical and operational features

• Application and wear: Patient‑applied to the upper arm; designed for minimal discomfort during insertion.
• Sensor duration: 15 days of wear for FreeStyle Libre 3 Plus sensor.
• Alarms and alerts: Optional high/low glucose alarms (notifications require alarms enabled and the sensor within range of the reading device).
• Data access: Continuous streaming to compatible smartphones; historical glucose data available through the app and compatible cloud services.

Compatibility & apps
The Libre app must be downloaded to view sensor readings on a smartphone. App compatibility is limited to specific mobile devices and operating systems; device compatibility and registration with LibreView may be required for cloud access and clinician data sharing.

Eligibility & programs
Certain patients may qualify for sample or voucher programs for FreeStyle Libre 3 Plus or FreeStyle Libre 2 Plus sensors; eligibility criteria, age limits and program availability vary by region and payer policies (including Medicare where applicable).

Safety & usage notes
The sensor is water‑resistant up to 1 meter for up to 30 minutes; do not immerse longer than 30 minutes. Fingerstick blood glucose tests may be required if sensor readings and symptoms do not match or when prompted within the first 12 hours of sensor use. Alarm notifications are received only when alarms are enabled and the sensor is in range of the reading device. Individual results may vary; this information does not replace professional medical advice.

Technical specifications

• Included items: Libre 3 Plus sensor, Libre 3 sensor (model variations), Libre app and, depending on configuration, a Libre 3 reader.
• Sensor wear time: 15 days (FreeStyle Libre 3 Plus sensor).
• Application site: Back of the upper arm; patient‑applied.
• Warm‑up time: 60 minutes required after sensor insertion.
• Water resistance: Up to 1 m for up to 30 minutes; do not immerse longer than 30 minutes.
• Pediatric clearance: Libre 3 cleared for children 4 years and older; Libre 3 Plus cleared for children 2 years and older (regional approvals may vary).
• Alarms: Optional high/low glucose alarms; notifications require alarms enabled and sensor within range.
• Accuracy: Proven accuracy reported in published data and product documentation.
• Connectivity: Streams readings to compatible smartphones via the Libre app; device/OS compatibility required.
• Additional notes: Fingersticks may be required if readings and symptoms disagree or when the Check Blood Glucose symbol appears within the first 12 hours.