Dexcom G7 Continuous Glucose Monitor Cleared by FDA for All Types of Diabetes

The prevalence of diabetes (type 1 and type 2) is projected to increase by 54 percent between 2015 and 2030, affecting almost 55 million Americans. One way diabetics manage their condition is with continuous glucose monitors (CGMs), small wearable sensors that measure blood glucose levels continuously throughout the day. Data about their glucose levels is typically sent to a wearable device or a mobile app. CGMs can alert diabetics sufficiently in advance of too high or low blood glucose levels, allowing the wearer to improve the situation with insulin, for example.

Many CGM devices are on the market and are relatively accurate and easy to use. Dexcom, Inc., a leader in diabetes care technology, develops small, wearable CGMs that send glucose information to your mobile device (e.g., a cellphone) every five minutes. Although their Dexcom G6 CGM System is currently on the market, on December 8, 2022, Dexcom announced in a press release that their new Dexcom G7 CGM System has been cleared by the US Food and Drug Administration (FDA) for use by people aged two years or older with any type of diabetes.

This FDA clearance will provide more people access to an easy-to-use and powerful diabetes management tool. Since it has been cleared as an integrated CGM system, the Dexcom G7 will be part of the most connected global CGM ecosystem. The CGM can be integrated with insulin delivery systems and connected to devices like Apple watches and popular health apps.

The Dexcom G7 is expected to launch in the US in early 2023.

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The Dexcom G7 CGM System Builds on Existing Technology

The G7 version of Dexcom’s CGM System includes the useful aspects of the predecessor G6 System, which was already small and required no finger pricks or scanning and calibration. The G7 is smaller, more discreet, and easier to use. In terms of speed, it has the fastest sensor warmup period at thirty minutes and gives users a twelve-hour grace period to replace any finished sensors.

With a MARD (mean absolute relative difference between CGM and YSI values) of 8.2 percent, the Dexcom G7 is the most accurate CGM cleared by the FDA. Dexcom G7 builds on the existing performance of older Dexcom CGMs, which have been clinically proven to reduce hyperglycemia and hypoglycemia and lower hemoglobin A1C levels.

Additionally, the mobile app for the G7 System has been simplified, has improved alert settings for enhanced safety and a redesigned receiver that is more vibrant and easier to read. Real-time glucose readings are automatically sent to compatible display devices (e.g., Apple watches, Garmin, etc.) every five minutes. Due to the improved alert settings, the Dexcom G7 is the only CGM that offers predictive alerts that recognize potentially dangerously low blood glucose incidents twenty minutes before they occur.

The sensor of the G7 System is indicated for wear on the upper arm for all patients aged two years or older, or the upper buttocks for those aged seventeen and under.

Dexcom’s Low Cost and High Efficacy for Diabetes Management

Presently, Dexcom is the most covered CGM on the market, with Dexcom users paying much less than people using other CGM brands. A third of patients pay nothing out of pocket, and most pay under forty dollars per month. The device is currently reimbursed by 97 percent of private insurance companies and Medicare across the US.

Since diabetes is projected to become more prevalent in coming years, access to affordable technology that can improve the quality of life of those affected is crucial. Dexcom is also planning to integrate the G7 device into automated insulin delivery systems, which could automate diabetes management for patients.

The Dexcom is also beneficial for families of patients that may want to stay updated about their health status, as well as healthcare professionals. Thomas Grace, MD in Findlay, Ohio, states that “the integration of Dexcom Clarity into the mobile app provides easy access to retrospective insights about a patient’s glycemic management during in person or telehealth appointments.”