One Drop Announces FDA Clearance and One Drop | Premium Launch in US, UK, and EU

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Company announces FDA clearance and CE mark approval of mobile blood glucose monitoring system One Drop | Chrome, and the official launch of its monthly subscription service, One Drop | Premium, available for orders in the US, UK and EU immediately.

December 6, 2016 — New York — One Drop today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance and Conformité Européene (CE) mark approval for One Drop | Chrome, a beautiful blood glucose monitoring system that marries modern design with advanced medical and mobile technology. One Drop | Chrome is available as part of One Drop | Premium, the first-ever monthly subscription service to provide affordable, accessible diabetes care — unlimited blood glucose testing supplies and 24/7 live in-app support from diabetes experts — all for less than a monthly co-pay.

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

One Drop is not only changing the look and feel of diabetes devices — it’s providing affordable, accessible, and effective diabetes care at scale. Today, diabetes affects almost 500 million people worldwide and costs $825 billion per year due to direct costs, healthcare services, loss of productivity, and disability. Globally, healthcare costs continue to outpace inflation. These expenses steadily increase the financial burden of diabetes on both individuals and governments, exacerbating health outcomes by placing essential treatment out of reach for millions of people.

One Drop | Premium directly reduces these costs. For $39.95 or less per month (without insurance), the One Drop | Premium monthly subscription service provides:

  • One Drop | Chrome with Unlimited Testing Supplies: One Drop | Chrome not only meets the highest standards of accuracy, but it also wirelessly transmits blood glucose data directly to the cloud via the One Drop | Mobile app for iOS and Android. Unlimited blood glucose test strips are delivered on-demand directly to the doors of One Drop | Premium subscribers — no prescriptions, no insurance, no appointments, and no hassles.
  • One Drop | Experts for Anytime Care: One Drop | Experts moves diabetes education out of the clinic and into the lives of people with diabetes. Each One Drop | Premium subscriber has his/her own “Expert” (Certified Diabetes Educator) available 24/7 for guidance, support, and anytime care. Experts deliver personalized digital therapeutics programs to help people with diabetes define and achieve their health management goals. Subscribers can communicate with their Experts anytime via in-app chat; all data recorded in the app is available to Experts in real-time, allowing them to provide relevant behavioral guidance in the moments when subscribers need it most. No appointments necessary.
  • One Drop | Mobile: One Drop | Mobile is an award-winning, cloud-based diabetes management solution delivered entirely via mobile app on iOS and Android. One Drop | Mobile provides real-time and historical blood glucose data and analytics to subscribers and their healthcare providers, allowing both to see relationships between specific health behaviors and health outcomes. One Drop | Mobile also includes a fully-featured Apple WatchOS app for logging and analyzing diabetes data on the go. One Drop | Mobile is the only diabetes management platform that offers comprehensive self-care, peer-support, and expert support all in one place.

One Drop | Chrome will be sold exclusively by One Drop (http://onedrop.today/) and Apple (http://store.apple.com). One Drop is accepting orders immediately for both One Drop | Chrome and One Drop | Premium in-app and online (US, UK, and EU) and has already begun shipping to US customers. One Drop | Chrome will be available via the Apple Store online (US only) in mid-December.

One Drop | Mobile has been available for free in the App Store since April 2015 and on Google Play since September 2016, and can be downloaded here:

The iOS app is now available in four different languages — English, Spanish, Chinese, and Arabic — and is used by people with diabetes in 195 countries worldwide. It has quickly become the most powerful, elegant, comprehensive, and fully-integrated diabetes management solution in the market, serving as a natural hub for all diabetes-related health data. Full integration with Apple HealthKit allows One Drop | Mobile users to sync blood glucose, fitness, nutrition, and other health data from thousands of apps and devices, including:

  • Dexcom, One Touch, Accu-Chek, Agamatrix, iHealth, Dario
  • Apple Watch, Garmin, Fitbit, Nike+, UP by Jawbone, Misfit, Pebble, Withings
  • My Fitness Pal, Lose it!, Lark, Weight Watchers, Human, Strava

One Drop plans to bring the same rich, integrated mobile experience to Android users via integration with Google Fit, as well as other Android-based health data platforms, in 2017.

Because of One Drop | Mobile’s seamless user experience and deep data integration, in just 18 months, One Drop | Mobile users have already contributed over 100,000,000 health data points toward better understanding diabetes. Cumulatively, One Drop users have logged in 2,000,000 times, spent more than 3,000,000 minutes in the app tracking blood glucose, medication, food, and physical activity, and are adding to the rapidly growing numbers of cloud-based health data that is paving the way for medical progress.

One Drop has also conducted a preliminary analysis of recent data collected from people with diabetes using One Drop | Mobile and One Drop | Experts for four consecutive weeks. This data shows that these users:

  • Consistently tracked their food and blood glucose over time
  • Increased their average number of in-range blood glucose readings by 40%
  • Reduced their average percentage of high blood glucose readings from 18.5% to 3.7%
  • Reduced their average blood glucose value from 185 mg/dL (A1c 8.1%) to 158 mg/dL (A1c 7.1%)

“It’s crucial that any diabetes solution drives evidence-based results,” said Dachis. “With One Drop | Premium, we are delivering a well-designed, evidence-based diabetes solution that offers accessible, affordable, scalable, comprehensive care to anyone, anywhere in the world. In doing so, we empower everyone with diabetes to make better choices, lead fuller lives, and achieve meaningful improvements in their health outcomes.”

About One Drop
One Drop (Informed Data Systems Inc.) is a digital health company harnessing the power of mobile computing and data science to empower people with diabetes to live healthier lives. The One Drop | Mobile solution is available for free worldwide. One Drop | Premium is a consumer subscription service available for purchase in-app (iOS and Android) and at http://onedrop.today/. One Drop also offers enterprise solutions to insurers, health care provider networks, and self-insured employers to dramatically lower the cost of caring for people with diabetes. For more information, contact just@onedrop.today

Press Contact
Rachel M. Sanchez


About the Author

Rachel Sánchez-Madhur
Living with T1D for 22+ years. Low-carb foodie, wine enthusiast, yogi, and dog-lover. Consumer Marketing, Strategy, and Customer Success at One Drop.


  1. James
    Posted on January 31, 2017 at 3:43 pm

    I like what your doing but it cost way to much. My copay is only 25 so it’s not cheaper. We pay for tons of stuff that is almost 500 a year.

  2. Britt
    Posted on December 13, 2016 at 6:19 pm

    With the new technological advances , with all of the new data and work with the FDA … is there any outlook on a carbohydrate .. correction .. planned exercise type .. “Bolus wizard” Calculator that could be integrated into the One Drop app ? That would make this the ultimate in ultimate of apps for total management.

  3. Matt Clausen
    Posted on December 13, 2016 at 3:24 pm

    Loved the article and I am very interested in this! You mentioned that the cost of the One Drop service is less without insurance: “One Drop | Premium directly reduces these costs. For $39.95 or less per month (without insurance).”

    Is that implying that the One Drop membership fee would be covered by insurance? I’m trying to do a cost analysis to see if it’s cheaper than what I’m paying now. Thanks!

    • Mary Elizabeth
      Mary Elizabeth Says :
      Posted on December 18, 2016 at 8:52 pm

      Hi Matt – thanks for getting in touch! Right now, One Drop | Premium is direct to consumer. Our goal, though, is to work with insurers to eventually get these costs paid for by insurance.

  4. Andrew Stivelman
    Posted on December 12, 2016 at 9:01 pm

    When will this come to Canada? I’m a great fan of OneDrop and am waiting eagerly to be able to use these products. Thanks.

  5. Nancy Hearn
    Posted on December 9, 2016 at 4:46 pm

    I ordered my chrome late yesterday. I hit a c instead of a d in my iclou’d’.com address. I did not see it until after I ordered it. I immediately submitted an email but have not heard a word back yet. I am so excited and ready to get the chrome.

    I wanted you to know how lucky you are to have Jeff Dachis who I think is an amazing leader! He spoiled me by returning emails so quicklyin the beginning, but I know you are probably all busy like crazy with rollout at Christmas time.

    I hope I did not upset the system or the applecart! I will be patient. I promise!