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 CORPORATION
MannKind 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 DROP
One 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