IN BRIEF The traditional approach to integrating new therapies involves long, expensive roadmaps with evidence generation required for multiple stakeholders, most notably regulators and clinicians. More recently, new technologies such as insulin delivery systems and continuous glucose monitoring devices have become mainstream without complete clinical evidence being available when they were first introduced. There is tremendous enthusiasm from investors, industry, and people with diabetes regarding the potential of digital health to add value to diabetes care, and this enthusiasm exists despite a paucity of high-quality clinical evidence from traditional randomized clinical trials. Moreover, the potential of diabetes digital health technologies has been recognized by the U.S. Food and Drug Administration and other regulators, who are changing their approaches to allow easier, earlier access to diabetes software and devices. This wager that digital health will add value makes sense.

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Digital health can be defined simply as the concept of health care meeting the Internet. In practical terms, this consists of (1) a wearable (or implanted) sensor with wireless communication, (2) a smartphone to receive the information, and (3) software (known as a mobile application or an app) to process the information. Overall, a common function of digital health technology is to provide some type of picture or interpretation of the data, or decision support, or in some cases, even an automatic action in the body triggered by the software. The aim of digital health is to facilitate the four purposes of health care: diagnosis, monitoring, treatment, and prevention. Digital health can be useful to support the first two purposes and can lead to changes in behavior (such as adopting a healthy lifestyle or supporting healthy engagement with medications) to support the second two purposes. The benefits of digital health depend on the perspective of the stakeholder, including patients, health care professionals, and payers. Digital health tools need to demonstrate usability, clinical benefit, economic benefit, security, and safety to satisfy various stakeholders. 1 Exciting Times These are exciting times for digital health systems for diabetes. Many novel digital health tools, such as wearable/portable/implantable sensors and companion software to provide information, decision support, or even control of a drug delivery system are being developed. 2,3 Data from the investment, academic, and regulatory communities indicate that there is a recent surge of interest in digital health as a paradigm for treating diabetes and other chronic diseases. Going forward, four trends could lead to significant advances in digital health moving to becoming mainstream in diabetes care. These trends include (1) increasing financial investment in digital health technology development, (2) accelerating execution of new ideas and technologies for digital health from academia and industry, (3) more streamlined regulation of the digital health industry by the Food and Drug Administration (FDA), and (4) increasing use of real-world data (RWD) collection by mobile apps to support clinical research (the latter to facilitate the input of data directly by participants, which can also be linked to electronic health data supporting traditional clinical trials, pragmatic trials, observational studies, and registries). Together these trends augur well for the use of digital health tools.

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TNDigital health tools have the potential to help improve the lives of people living with diabetes and those who care for them. In the opening session, four leaders in the field of diabetes apps spoke about their digital solutions, key partners and considerations in the development process, how they provided evidence and evaluated the success of their apps, and the importance of aligning financial incentives for users, health care providers, and payers. The panel discussed three barriers to adoption of digital health and provided potential solutions. First, different users have different needs, and apps cannot provide a single solution for multiple situations. In AbstractThe purpose of developing mobile applications for diabetes is generally to: (1) provide enhanced access to timely information for patients, health care professionals, and researchers; (2) facilitate remote monitoring and diagnosis of patients, often based on information delivered by wearable devices; (3) provide decision support to assist patients in selecting treatment; or (4) deliver timely recommendations for treatment to increase adherence to prescribed therapy. There is a perception that mobile applications can provide meaningful clinical benefits, however, there is only sparse convincing evidence to support this belief at the present time. Compounding this problem is the short life span of digital software, such that if a traditional type of randomized controlled trial is conducted on a product, by the time the study has been designed, approved by an IRB, conducted, and analyzed, the product might have significantly changed to a next generation system. Because of great interest in establishing what are the potential benefits, metrics of success, and appropriate components of mobile applications for diabetes, Diabetes Technology Society and William Sansum Diabetes Center launched the Digital Diabetes Congress, March 7-8, 2017, in San Francisco. This report contains summaries of the meeting's 12 sessions. Each summary was written by the session's moderator who helped develop the session prior to the event and keep it on track during the event. This meeting report presents a summary of how 57 panelists, speakers, and moderators, who are leaders in digital health, see the current and future landscape of digital health tools applied to diabetes.