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MannKind and One Drop Partner to Launch the A-One Clinical Trial

02:35 EDT 7 Aug 2017 | PR Newswire

NEW YORK and VALENCIA, Calif., Aug. 7, 2017 /PRNewswire/ -- MannKind Corporation (NASDAQ: MNKD) (TASE: MNKD) and One Drop today announced the first step of their collaboration with the launch of the A-ONE study, a randomized controlled trial investigating the use of Afrezza® inhaled insulin and One Drop's integrated digital diabetes care platform.

In May 2017, MannKind and One Drop announced a memorandum of understanding to explore collaborations related to One Drop | Premium (i.e., One Drop | Mobile app, One Drop | Chrome meter and test strips, One Drop | Experts coaching service) and Afrezza®, MannKind's inhaled rapid-acting mealtime insulin. One goal of the collaboration is to identify ways of simplifying the complexity of starting and staying on mealtime insulin along with Customized Coaching to help people achieve their A1C goals.

Appropriate people with type 2 diabetes who meet inclusion criteria will be randomized to one of two treatment arms:  Afrezza® with One Drop | Premium – or – One Drop | Premium alone. Changes in hemoglobin A1C, quality of life, self-care, treatment satisfaction, and other metrics will be assessed.  People with type 2 diabetes interested in learning more should email Aone@onedrop.today.

Dr. Raymond Urbanski, Chief Medical Officer of MannKind Corporation, said, "This study is intended to evaluate whether combining a solutions-oriented digital disease management platform like One Drop with an innovative drug like Afrezza® will provide patients with an improved ability to manage their diabetes."

"One Drop is a unique, fully integrated solution with the prospects of a huge health benefit," says Dr. Chandra Osborn, VP of Health and Behavioral Informatics at One Drop. "We know each piece of the puzzle works, and now we want to see how well they work together. With 9 peer-reviewed outcomes shared at medical meetings and a paper in press at JMIR Diabetes, One Drop is committed to delivering the most effective diabetes management solution in the market. The combination of One Drop with inhaled insulin could offer consumers, health care providers, and payers a potentially powerful solution with unprecedented benefits."

"Diabetes technology is evolving in a very exciting way," said Jeff Dachis, CEO and Founder of One Drop. "But not surprisingly for the vast majority of people with diabetes worldwide, expensive sensors, automated insulin delivery solutions, or call center approaches to care can create barriers and challenges to effective disease management. However, we are excited to evaluate whether a completely integrated digital diabetes therapeutics platform — encompassing evidence-based interventions, ADA-recognized diabetes education and coaching, wireless blood glucose tracking, user-centered design, robust data science, and an innovative pharmaceutical product like MannKind's Afrezza — can deliver improved health outcomes at a fraction of the cost of current standards of care."

At this year's American Diabetes Association 77th Scientific Sessions, Evidation Health Inc. reported results of a non-randomized study evaluating the One Drop | Mobile app and One Drop | Experts coaching service. In only 3 months, people with type 2 diabetes reduced their A1c by [1]:

  • .90% among study completers
  • 1.00% among active users who used the app and messaged a coach at least once
  • 1.32% among active users with baseline A1c ≥ 9.0%

Leveraging data collected in-app, One Drop reported that these users [2]:

  • reduced carbohydrate intake by >10 grams per meal;
  • increased activity by 25 minutes per week;
  • decreased average blood glucose by 29 mg/dL (a 1.00% A1c reduction);
  • reduced glycemic variability; and
  • increased the percentage of in-range blood glucose values.

_______________
1 Kumar S., et al. Impact of a diabetes mobile app with in-app coaching on glycemic control. Late-breaking peer-reviewed poster presentation at the 77th Annual Meeting of the American Diabetes Association; San Diego, CA, USA, June 2017.
2 Osborn C.Y., et al The One Drop mobile app with in-app coaching improves blood glucose and self-care. Peer-reviewed poster presentation at the 77th Annual Meeting of the American Diabetes Association; San Diego, CA, USA, June 2017.

ABOUT MANNKIND CORPORATIONMannKind Corporation (TASE: MNKD) focuses on the discovery, development and commercialization of therapeutic products for patients with diseases such as diabetes. MannKind maintains a website at www.mannkindcorp.com to which MannKind regularly posts copies of its press releases as well as additional information about MannKind. Interested persons can subscribe on the MannKind website to e-mail alerts that are sent automatically when MannKind issues press releases, files its reports with the Securities and Exchange Commission or posts certain other information to the website. For more information on Afrezza, please visit www.afrezza.com.

ABOUT ONE DROPOne Drop (Informed Data Systems Inc.) is a digital health company harnessing the power of mobile computing and data science to transform the lives of everyone with diabetes worldwide.

The One Drop platform is evidence-based and clinically effective. It brings affordable, accessible diabetes care to everyone with diabetes and a smartphone, as well as their insurers and health care providers. One Drop's current offerings include:

  • One Drop | Chrome: One Drop's FDA-approved, CE-certified Bluetooth wireless blood glucose monitoring system, which meets the highest standards of clinical accuracy and wirelessly transmits blood glucose data to the cloud via the One Drop | Mobile app for iOS and Android.
  • One Drop | Plus: One Drop's newest subscription offerings, providing 50 to 100 blood glucose test strips per month for One Drop | Chrome and unlimited coaching via One Drop | Experts, starting at $13 per month.
  • One Drop | Premium: One Drop's unlimited subscription, providing unlimited blood glucose test strips for One Drop | Chrome and unlimited coaching via One Drop | Experts, starting at $33 per month.
  • One Drop | Experts: One Drop's 24/7, on-demand, digital diabetes education and coaching service, available as a standalone subscription, starting at $11 per month.* Each One Drop | Experts subscriber has his/her own "Expert" (Certified Diabetes Educator) available 24/7 for guidance, support, and anytime care. Experts deliver personalized digital therapeutics programs, including ADA-recognized diabetes education, 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 personalized behavioral guidance when subscribers need it most — no appointments necessary.
  • One Drop | Mobile: One Drop's free, 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 people with diabetes and their healthcare providers, allowing both to see relationships between specific health behaviors and health outcomes. One Drop | Mobile 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 | Professional: One Drop's HIPPA-compliant enterprise solution for insurers, healthcare provider networks, self-insured employers, and drug/device manufacturers seeking to dramatically improve health outcomes and lower the cost of caring for people with diabetes. One Drop | Professional delivers real-time data, real-time messaging, custom branding, custom content delivery, custom educational support, EMR/EHR integration, and the most affordable, effective, turnkey diabetes solution in market.

One Drop | Chrome is sold exclusively by One Drop (iOS, Android, and http://onedrop.today/), Amazon (http://www.amazon.com), and Apple (http://store.apple.com). One Drop's consumer subscription services are available for purchase in-app (iOS and Android) and at http://onedrop.today. The One Drop | Mobile solution is available for free download worldwide (iOS and Android). For more information, contact just@onedrop.today.

*The American Diabetes Association recognizes this education service as meeting the National Standards for Diabetes Self-Management Education and Support.

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SOURCE One Drop

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