One Drop Announces FDA Clearance And One Drop | Premium Launches In US, UK, And EU
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.
NEW YORK, Dec. 6, 2016 /PRNewswire/ -- 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 clinical 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 (on iOS, Android, and at 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:
- iOS: http://apple.co/1IWTvGk
- Android: http://bit.ly/2gLzk6y
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 amount 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.
Photo - http://photos.prnewswire.com/prnh/20161204/445313
Photo - http://photos.prnewswire.com/prnh/20161204/445314
Photo - http://photos.prnewswire.com/prnh/20161204/445315
Logo - http://photos.prnewswire.com/prnh/20161010/427008LOGO
Share this article