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September 6, 2022

New Meds and Tech from the PES Drugs & Therapeutics Committee – FreeStyle Libre 3™

New Meds and Tech from PES Drugs and Therapeutics committee

The FreeStyle Libre 3 is the third generation of Abbot Laboratories’ continuous glucose monitoring system intended for day-to-day glucose monitoring in patients with diabetes mellitus. The Food and Drug Administration (FDA) approved the product for use by individuals 4 years and older with diabetes mellitus on May 31, 2022. The device has been approved since September, 2020 in Europe.

The FreeStyle Libre 3 system consists of an integrated sensor and transmitter that sends glucose readings to a smartphone once a minute. The FreeStyle Libre 3 sensor is approximately 70% smaller than the Libre 2 sensor; about the size of two U.S. pennies stacked, whereas the FreeStyle Libre 2 sensor is about the size of two U.S. quarters stacked.1 Unlike prior FreeStyle Libre systems, the Libre 3 sensor does not need to be scanned, and there is no receiver. Each sensor lasts 14 days. Abbot’s press release noted that the Freestyle Libre 3 would be priced the same as previous generations1.

Abbot reports that the FreeStyle Libre 3 is more accurate than its previous generations with a mean absolute relative difference (MARD) of 7.9%, compared to a MARD of 9.3% for the FreeStyle Libre 2 and MARDS between 13.5% – 16.7% for the first generation FreeStyle Libre in the pediatric population.1-5 For comparison, the Dexcom G6 sensor is noted to have an overall MARD of 9.0%.6

The Libre 3 system sensor was cleared for use with FreeStyle iOS and Android mobile apps, which enables users to view glucose levels in real time, track glucose history and trends, and set up optional alarms for hypoglycemia and hyperglycemia. The integration with LibreView and LibreLinkUp allows family members and healthcare professionals to remotely monitor. 1 The FreeStyle Libre 3 sensor communicates via integrated Bluetooth with a range of up to 33 feet, which is noted to be 50% farther range compared to other continuous glucose monitors.1

REFERENCES: (last accessed on 6/24/2022):

  1. https://abbott.mediaroom.com/2022-05-31-Abbotts-FreeStyle-Libre-R-3-Receives-U-S-FDA-Clearance-Features-Worlds-Smallest,-Thinnest-and-Most-Accurate-14-Day-Glucose-Sensor
  2. Abbot Press Release. June 15 2020. https://abbott.mediaroom.com/2020-06-15-Abbotts-
    FreeStyle-R-Libre-2-iCGM-Cleared-in-U-S-for-Adults-and-Children-with-Diabetes-Achieving-
    Highest-Level-of-Accuracy-and-Performance-Standards.
  3. Massa Guy G, et al. Evaluation of the FreeStyle Libre flash glucose monitoring system in children and adolescents with type 1 diabetes. Horm Res Paediatr 2018;89(3):189-199.
  4. Edge J et al. An alternative sensor based method for glucose monitoring in children and young people with diabetes. Arch Dis Child 2017;102(6):543-549.
  5. Szadkowska A, et al. Flash glucose measurements in children with type 1 diabetes in real life settings: to trust or not to trust? Diabetes Technol Ther 2018;20(1):17-24.
  6. https://provider.dexcom.com/dexcom-cgm

Prepared on behalf of PES Drugs and Therapeutics Committee by Neha Patel DO (no disclosures) and Daniel Mak, MD (no disclosures)

Last updated: August 11, 2022

Posted in New Meds and Tech
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