A new category of medicine — digital therapeutics — is making it easier for people with diabetes to stay healthy.
More than 100 million Americans are living with diabetes or pre-diabetes, and the incidence of diabetes increases with age. This means that roughly a quarter of Medicare beneficiaries are facing this condition. Despite the prevalence of this condition, clinical resources can be few and far between, and they can be especially challenging to access for those who are at higher risk for poor outcomes.
Individuals with diabetes are at higher risk of developing other serious conditions including stroke, kidney disease, neuropathy, high blood pressure, and foot and eye complications. Troublingly, serious racial, economic, and geographic disparities exist in the prevalence of and outcomes for this condition.
Current treatments and resources have been unable to sufficiently address these unmet medical needs. However, a quickly evolving category of medicine has emerged that could help mitigate many of these substantial gaps in care.
The future of healthcare
Digital therapeutics (DTx) deliver therapeutic interventions directly to patients using scientifically developed, evidence-based, and clinically evaluated software to treat, manage, and prevent diseases and disorders. DTx products are subject to rigorous patient-centered core principles, an industry code of ethics, and product development best practices. DTx products can be used independently, alongside medications, or in tandem with clinician-delivered therapy.
They differ from pure lifestyle, wellness, adherence, diagnostic, and telehealth products, and they’re distinct from the over 350,000 digital health apps available online. The term “digital therapeutic” only applies to products that deliver therapeutic interventions to prevent, manage, or treat a medical disorder or disease; incorporate best practices relating to product design, clinical evaluation, usability, and data security; and are reviewed by regulatory bodies as required to support product claims regarding risk, efficacy, and intended use.
As clinicians, healthcare systems, employers, and insurers continue integrating these products into patient care, digital therapeutics will increasingly influence the delivery and consumption of healthcare around the nation and world.
A transformative option
The portability and scalability of DTx products uniquely position them as a transformative option for people with diabetes to better understand their health and gain a sense of control over their condition. Pew Research indicates that a large majority of the U.S. population owns a smartphone — even among older adults — and this number is likely to increase.
Since most DTx interventions are delivered at least in part through Android and iOS smartphones or tablets, few technical barriers exist to the implementation and scalability of DTx products in a multitude of settings. As such, digital therapeutics have the ability to provide patients with asynchronous support and therapy when they are actively experiencing symptoms or are unable to immediately access their healthcare providers.
The Digital Therapeutics Alliance (DTA) provides a library of DTx products that includes several tools to help patients manage diabetes, including BlueStar, d-Nav, Dario, and Insulia. Users of these tools say that digital technology and automated insulin management puts them at ease, takes the guesswork out of insulin dosing, and helps them be more compliant with the responsibilities of diabetes management.
Digital therapeutics also address some patient access issues, since physicians can monitor and analyze their patients’ blood sugar readings remotely and can more easily recommend changes in therapy or dose without the demands of patient time and expense. Research on these products has shown the impact they could have, especially if they’re made more widely available. The tools listed in DTA’s library have demonstrated success at lowering glucose levels and reducing total healthcare costs.
Given that many individuals with diabetes may not have local clinician support or the educational support necessary to manage their condition, providing wider access to DTx products may empower people with diabetes and reduce the current racial, economic, and geographic disparities in outcomes. Unfortunately, Medicare currently does not have a defined benefit category for DTx products, even though many have demonstrated strong records of health improvement and cost savings. Comprehensive, multi-faceted solutions are necessary to achieve better healthcare outcomes for people with diabetes.
It is crucially important that a key component of these plans includes the expansion of digital therapeutic coverage and patient access. We encourage legislators to direct CMS to expand access to DTx products by formally recognizing DTx products and codifying coverage, as well as expanding coding and payment systems to include the provision of these interventions.