FreeStyle Libre 3 (Select) — Glucose Monitoring Sensor: ABBOTT
ABOT3
Presentation
The FreeStyle Libre Select 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 and automatically sends readings every minute to the FreeStyle Libre 3 reader or the FreeStyle Libre 3 app via Bluetooth.
Information
Product details & mandatory information
Continuous glucose monitoring, without finger pricks
The FreeStyle Libre Select 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 in real time on the reader or smartphone.
24/7 monitoring for 15 days
Once activated, the sensor measures glucose every minute and records data every 5 minutes, with a 15-day rolling memory. The data generated includes the complete glucose profile: current value, trend arrow, variability and recent 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 10 metres of the sensor.
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 Select sensor is compatible with the FreeStyle Libre 3 reader and the FreeStyle Libre 3 app. It is activated with a simple scan (NFC) of the reader or smartphone, after which data is transmitted automatically, with no further scanning required.
EAN: 3664592000175
LPPR code: 1164815 (Interstitial glucose self-monitoring, 1 sensor, Abbott, FreeStyle Libre Select)
Medical device class: IIb
Note: FreeStyle Libre Select is a medical device. Seek advice from your healthcare professional. Please read the instructions for use carefully before use.
Technical specifications
Specification |
Value |
Glucose measurement method |
Amperometric electrochemical sensor |
Glucose result range |
40 to 500 mg/dL |
Sensor size |
5 mm high, 35 mm in diameter |
Sensor weight |
5 grams |
Power source |
1 silver oxide battery |
Sensor life |
Up to 15 days |
Memory |
15 days (glucose measured every minute, recorded every 5 minutes) |
Transmission range |
10 metres without obstruction |
Operating temperature |
Between 10 °C and 45 °C |
Applicator storage temperature |
Between 4 °C and 25 °C |
Relative humidity (operating and storage) |
Between 10 % and 90 % without condensation |
Water resistance |
IP27: immersion up to 1 metre for a maximum of 30 minutes |
Operating and storage altitude |
Between - 381 metres and 3048 metres |
Radio frequency |
BLE 2.402 to 2.480 GHz; GFSK; EIRP 4.6 dBm |
Indications
The FreeStyle Libre Select continuous 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 by scanning with the FreeStyle Libre 3 reader or app. Wait 60 minutes before the first reading. 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.
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).
Not compatible with automated insulin delivery pumps: unlike the FreeStyle Libre 3 Plus sensor, the FreeStyle Libre Select is not compatible with automated insulin delivery systems (hybrid closed-loop / closed-loop pumps, for example mylife™ YpsoPump® / mylife Loop or Omnipod® 5). It is intended for people treated with insulin injections (pen) or with an open-loop pump. People using or planning to use an automated insulin delivery pump should choose the FreeStyle Libre 3 Plus sensor instead.
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
