Which continuous glucose monitors (CGMs) have been FDA approved for the management of type 1 diabetes mellitus (DM), and what is a flash glucose monitoring system?

Updated: Oct 08, 2021
  • Author: Romesh Khardori, MD, PhD, FACP; Chief Editor: George T Griffing, MD  more...
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In December 2016, Dexcom’s G5 Mobile Continuous Glucose Monitoring System became the first CGM to win FDA approval as a replacement for finger-stick testing for determination of insulin doses, although twice-daily finger-stick testing was still required for calibration. [126]

In March 2018, the FDA approved Medtronic’s stand-alone CGM, Guardian Connect, which eschews use of a receiver and makes data viewable via a smartphone display alone. Receiving CGM data through its smartphone app, the device works with an artificial intelligence app to assess glucose level response to various factors, including an individual’s food intake, insulin dosages, and daily routines. The approval was made for patients with diabetes aged 14-75 years. [124]

In June 2018, the FDA approved the Eversense Continuous Glucose Monitoring system (Senseonics), the first continuous glucose monitoring system with a fully implantable glucose sensor, for persons aged 18 years or older with diabetes. Using a fluorescence-based sensor that a physician implants subcutaneously in the patient's upper arm (via an office procedure), the device has a transmitter that is worn above the sensor, with the CGM employing a mobile app to show glucose values and trends. In addition, the app alerts the patient to high and low glucose values, with the transmitter also emitting on-body vibration alerts. The device is intended for adjunctive use, with fingerstick monitoring and twice-daily calibrations required. The implant lasts for up to 3 months before needing replacement. [127, 128]

Flash glucose monitoring

Another technology, flash glucose monitoring, stores data in a wearable sensor that can be scanned for this information via a dedicated receiver or smartphone. [115] The FreeStyle Libre Flash Glucose Monitoring System (Abbott Diabetes Care), approved by the FDA in September 2017, allows patients to reduce the number of required finger-stick tests by measuring glucose levels using a self-applied sensor inserted into the back of the upper arm. [126]

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