One Drop gets FDA, CE Mark for blood glucose monitoring system and subscription plan

By Heather Mack
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New York-based One Drop has received FDA clearance for its mobile blood glucose monitoring system, One Drop Chrome. The system consists of the Chrome Meter lancing device, test strips and a companion app, and is also now officially available with a monthly subscription service called One Drop Premium. People in the United States, UK and European Union can start ordering the $39.95 subscription service immediately. 

One Drop Chrome wireless transmits blood glucose data directly to the cloud via the One Drop app, which is available on both iOS and Android. Subscribers get unlimited test strips delivered to their door on-demand without the need for insurance or appointments. On the companion app, users with type 1, type 2 or pre-diabetes can log a variety of information: glucose, diet, activity and insulin. Users can share that information anonymously with a community of users, and the platform also offers users actionable insights based on their data.

Premium subscribers also get their own certified diabetes educator coach, who is available 24/7 via in-app chat. All user data is available to the coaches in real time in order to help them give users relevant behavioral guidance.

The goal is to make it hassle-free and affordable for anyone with diabetes to manage their condition, and Dachis has previously told MobiHealthNews that design was a key part of the development of the system, in large part to reduce the stigma of using a medical device in everyday life.

“One Drop is designed by people with diabetes and for people with diabetes,” One Drop CEO and Founder Jeff Dachis said in a statement. “We’re transforming the diabetes management experience by designing empowering, beautiful products love to use, while also delivering outstanding evidence-based results.”

Preliminary studies of One Drop’s app and coaching services showed users consistently tracking their food and blood glucose over time, which resulted in an increased average number of in-range blood glucose readings, and a reduction in their average percentage of high blood glucose readings.

The One Drop Chrome system and subscription service comes about a year after the direct-to-consumer app debuted on iOS. The app was then made available to Android in October while the company was awaiting FDA clearance. The One Drop App, which can integrate with Apple Health to sync data from other apps and devices including CGMs and Bluetooth-enabled meters, has been used by people in 190 countries, comprising over 85 million points of data. The Chrome system will be sold exclusively on the One Drop website and via Apple.