Presentation

The FreeStyle Libre 2 Plus is a continuous interstitial glucose monitoring sensor that requires no fingertip pricking. Worn on the back of the upper arm, it measures glucose levels day and night for up to 15 days. Readings are sent automatically every minute to the FreeStyle LibreLink app, or viewed by scanning the sensor with the FreeStyle Libre 2 reader.

Information

Product details & mandatory information

Continuous glucose monitoring, without finger pricks

The FreeStyle Libre 2 Plus puts an end to the constraints of traditional glucose monitoring. No more fingertip pricking: the discreet, easy-to-apply sensor measures glucose in the interstitial fluid and displays results on the reader or smartphone.

24/7 monitoring for 15 days

Once activated, the sensor measures glucose every minute and keeps an 8-hour rolling memory. The data generated includes the complete glucose profile: current value, trend arrow, variability and the last 8 hours of history, helping users better understand how their glucose changes and anticipate fluctuations.

Optional alarms for greater peace of mind

The sensor features a data transmission system that generates optional low-glucose, high-glucose and signal-loss alarms. When activated, these alarms alert the user as soon as the glucose level crosses the defined threshold, provided the reader or smartphone remains within 6 metres of the sensor.

Compatible with the Omnipod 5 insulin pump

The FreeStyle Libre 2 Plus is approved for use with the Omnipod 5 automated insulin delivery system (tubeless hybrid closed-loop). Paired with an active Pod, it enables Automated Mode, in which the Pod adjusts insulin delivery every 5 minutes based on the sensor readings.

Water-resistant and comfortable for daily life

With an IP27 protection rating, the sensor withstands immersion in water up to one metre for a maximum of 30 minutes. It therefore keeps working in the shower, in the swimming pool or during physical activity. Small (5 mm high, 35 mm in diameter) and lightweight (5 grams), it is easy to forget throughout the day.

Compatibility

The FreeStyle Libre 2 Plus sensor is compatible with the FreeStyle Libre 2 reader and the FreeStyle LibreLink app. With the app, data is transmitted automatically every minute, with no scanning. With the reader, a scan (sensor held within 4 cm) is required to display the glucose level. It is also compatible with the Omnipod 5 automated insulin delivery system.

Note: first-generation FreeStyle Libre readers are not compatible with this sensor.

EAN: 3664592000168

LPPR code: 1123259 (Interstitial glucose self-monitoring, 1 sensor, Abbott, FreeStyle Libre 2 Plus)

Medical device class: IIb

Note: FreeStyle Libre 2 Plus is a medical device. Seek advice from your healthcare professional. Please read the instructions for use carefully before use.

Technical specifications

Indications

The FreeStyle Libre 2 Plus flash glucose monitoring system is indicated for measuring glucose levels in the interstitial fluid in people (aged 2 years and older) with diabetes mellitus, including pregnant women. It is designed to replace blood glucose measurement in diabetes management, including insulin dosing. Use in children (aged 2 to 12 years) is limited to those supervised by a caregiver who is at least 18 years old.

Instructions for use

Apply the sensor only to the back of the upper arm, on an area of skin free of scars, moles, stretch marks or bumps, and at least 2.5 cm away from an insulin injection site. Clean the skin with plain soap, dry it, then wipe with an alcohol pad and allow to air dry. Prepare the applicator, apply the sensor firmly to the prepared site, then activate it with the FreeStyle LibreLink app (NFC scan) or the FreeStyle Libre 2 reader (held within 4 cm). Wait 60 minutes before the first reading. With the reader, scan the sensor regularly: the rolling memory is 8 hours, beyond which the earliest data is lost. Remove the sensor after 15 days by slowly peeling back the edge of the adhesive.

Storage and usage advice

Store the applicator between 4 °C and 25 °C.

Keep out of reach of young children: the system contains small parts that may be hazardous if swallowed.

Remove the sensor before any magnetic resonance imaging (MRI) examination.

Do not ignore symptoms that may be due to low or high glucose. If symptoms do not match the displayed result, or if a result is suspected to be inaccurate, confirm with a fingertip blood glucose test and consult a healthcare professional.

Glucose alarms should not be used on their own: interpret them together with the current glucose level, the trend arrow and the graph. To receive them, the reader or smartphone must remain within 6 metres of the sensor.

Use of the system has not been evaluated in people on dialysis, in people under 2 years of age, or with implanted medical devices (for example a pacemaker).

In the event of significant skin irritation under or around the sensor, remove the sensor, stop using it and consult a healthcare professional.

The removed sensor and the applicator must be disposed of in accordance with local regulations in force. Used FreeStyle Libre sensors can be recycled.

Kit contents

1 sensor (15-day wear time), 1 sensor applicator, the product instructions.

Manufacturer information

ABBOTT France S.A.S — Abbott Diabetes Care

40-48, rue d'Arcueil

CP 10457

94593 RUNGIS CEDEX

FRANCE