Abbott’s Libre 2 CGM approved by the FDA

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Abbott’s Libre 2 CGM, approved in Europe since October 2019, received FDA approval for use in the U.S. on June 15, 2020.

  • Approved for adults and children ages 4 years and older who have diabetes.
  • Measures glucose levels every minute, rather than every 5 minutes with other CGMs.
  • Still not a full CGM. Alerts sound on the receiver/wanding device for high or low readings. The user then scans the sensor with the wanding device to see the glucose.
  • Abbott is developing a future version (Libre 3?) that provides a continuous stream of data, including glucose readings, without any sensor-scanning. This would allow integration into Automated Insulin Delivery (AID) systems.
    • Competition to Libre 2 includes Dexcom’s next-gen G7, developed with Verily/Google. This mini-sized no-calibration, 14-day, low cost, throwaway CGM should be released later in 2020.
    • Medtronic had planned to use a 7-day, calibrate-only-on-the-first-day Guardian sensor for use with the 780 pumps, but is expected to readjust these plans.
  • Carries the iCGM (interoperable CGM) designation from the FDA. This allows it to eventually operate with pumps like Tandem t:slim (mid-2020) and Omnipod Horizon software (late 2020) that have previously achieved the interoperable designation from the FDA, as well as the Bigfoot Asante hybrid pump (2023) and smart insulin pens like Companion Diabetes InPen.
  • Highly accurate with a mean absolute relative difference (MARD) of 9.2% in adults and 9.7% in children. (lower is better). Its accuracy is similar to the Dexcom G6 iCGM and better than the Medtronic Guardian 3.
  • Shown to substantially improve A1c levels in both Type 1 and Type 2 diabetes.
  • The user can choose sound or vibrate for alerts, loss of connection with the receiver, and adjust thresholds for high and low glucose.
  • List price is $54 for each 14-day sensor and $70 for the reusable handheld reader, identical to the current Libre with 4 days longer wear. (Pharmacies often discount these retail prices.) Cost is roughly one third that of other CGMs. Those with commercial insurance may pay as little as $10 for 2 sensors, 4 weeks of readings.
  • High-dose vitamin C (> 500 mg/day) may falsely raise sensor readings. Acetaminophen (Tylenol, etc.) does not affect readings.
  • Remove the sensor before MRI, CT scans, X-rays, or diathermy treatments.

Read the full release here.

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