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Profil Institute and mySugr Collaborate to Advance Evidence-Based Clinical Validation of Diabetes mHealth Solutions

Companies to conduct a development program to investigate the clinical value and health economics of mySugr's portfolio of digital health solutions for diabetes management

Profil Institute for Clinical Research, a science-driven clinical research organization (CRO) focused exclusively on metabolic diseases, and mySugr, a leading diabetes mobile app developer, announced today a partnership to design and conduct a clinical research and development program for mySugr's portfolio of diabetes mobile health applications.

Under the terms of the agreement, the companies plan to jointly design and execute a development program aimed at enhancing and validating the clinical and health economic impact of mySugr's digital health solutions for diabetes management.  As part of a multi-year plan, the companies plan to generate, analyze and publish data from prospective and retrospective studies to increase evidence-based research in the field of mobile health app development.

mySugr's Logbook is widely recognized as one of the most successful mobile health apps for diabetes with a rapidly growing user base of more than 700,000 registered users worldwide.  The company's portfolio of digital diabetes solutions showcases a stand-out user experience that combines therapy management and motivational gaming components to inspire patient engagement, while its Logbook and Importer apps seamlessly integrate with a growing number of medical devices, including Roche's Accu-Chek® Connect family.

Profil Institute is a leading early phase CRO focused exclusively on metabolic diseases.  Its experience encompasses every clinically relevant drug class in diabetes and more than 280 clinical research projects, including studies for most of the diabetes medications and devices on the market today.

"Patients already understand the positive impact of mySugr's digital health solutions on their diabetes therapy. However, digital diabetes therapy still lacks a clear clinical interpretation of the vast amount of data generated. We need to better understand the exact impact of digital tools by examining evidence-based outcomes to determine where we can add even more value to diabetes therapy," said Frank Westermann, CEO of mySugr.  "We're excited to partner with the team at Profil Institute, an organization that shares our passion and deep commitment to making a difference in the lives of people with diabetes. With its successful and long-standing track record at the forefront of diabetes innovation, Profil Institute was the obvious partner-of-choice as we embark on groundbreaking research of digital diabetes therapy. Together, we're driving change."

"mHealth and telemedicine have the potential to improve the quality of clinical care across a wide range of chronic disorders.  This is particularly true for diabetes, where patients themselves are often required to collect, integrate, analyze, share and respond to a wide range of personal health data," said Dr. Marcus Hompesch, Chairman and CEO of Profil Institute.  "Clinical data from well-designed studies will be crucial in demonstrating the impact of digital health on health outcomes, resulting in greater opportunities for mobile apps to be useful for broader medical care situations.  We're pleased to join forces with mySugr in the clinical validation of their mobile app technology, which has already proven to be a powerful companion tool for patient engagement."

About mySugr GmbH
Founded in 2012, by people with diabetes for people with diabetes, mySugr has offices in Vienna, Austria and San Diego, California. They create innovative digital health solutions for people with diabetes to minimize the daily struggles and challenges in diabetes management. True to their motto, "we make diabetes suck less," mySugr becomes a loyal companion by providing comprehensive care through app-based services during the often lonely and confusing times between doctor visits. Their products are characterized by the intelligent combination of design, technology, and diabetes expertise to help people better manage their blood sugar and live happier healthier lives. Particularly well-known is mySugr Logbook, which is available in 51 countries and 13 languages. Often called the world's most popular diabetes app, Logbook focuses on passive data collection through connected devices, insulin dose calculations (approved for use in Europe), and simplified reporting for effective therapy management with clinicians. For more information, please visit mysugr.com.

About Profil Institute for Clinical Research, Inc.
Profil Institute is full-service clinical research organization (CRO) focused on diabetes, obesity and NAFLD/NASH. The company was developed at the heart of diabetes research with its scientists hailing from top research and academic institutes, amongst them the World Health Organization Collaborating Center of Diabetes at Heinrich-Heine University, National Institutes of Health, Sanford-Burnham Research Institute, and the Salk Institute for Biological Studies.  Profil Institute's team of experts in clinical development work with clients throughout the U.S., Europe and Asia to support their metabolic drug and device candidates from IND/CTA and NDA/ANDA regulatory filing to final report publication and licensing support. The company's experience in early phase clinical research for metabolism is unparalleled, having completed more phase I/II diabetes studies in the U.S. than any other provider(1), encompassing every clinically relevant drug class in diabetes and more than 280 clinical research projects.  More information can be found at profilinstitute.com.

(1)    U.S. clinical trial data in diabetes, showing that Profil Institute's early phase facility in Chula Vista has completed more Ph I/II T1DM and T2DM studies in the U.S. than any other clinical research site, provided by Citeline's SiteTrove, a service offered by Informa Pharma Intelligence, April 2016

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