Digital Health Interventions for Diabetes: Everything to Gain and Nothing to Lose.

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.