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Are digital therapeutics the answer to diabetes management?
Exploring the interventional role of DTx in endocrine disorders
While the burden of chronic disease is increasing steadily worldwide, the ability of healthcare professionals to keep pace with this rising burden is declining. In response, digital therapeutics (DTx) are reducing this burden by enabling clinicians to monitor their patients remotely and in real-time, while also empowering the patient to become an active participant in their health and disease management.
What are digital therapeutics?
An article in Diabetology & Metabolic Syndrome describes digital therapeutics as “therapeutic interventions that are driven by high-quality software programs to prevent, manage, or treat a medical disorder” (Rassi-Cruz et al., 2022). These technologies hold the power and potential to drastically improve patient outcomes from certain chronic diseases. DTx applications use various web and/or cloud platforms to create personalized and rapid care management of chronic conditions such as diabetes. Accordingly, the DTx market is multiplying as the health care industry responds to the evolving digital world.
Digital therapeutics and endocrine disorders
Endocrine disorders offer a significant opportunity for the use of digital therapeutics. How DTx can manage and/or treat diseases varies depending on the condition, but overall, they give patients the tools they need to become active members of their healthcare teams and provide patients and their clinicians with real-time data (e.g., weight or blood glucose levels) they can act upon for better disease management. If used correctly, DTx can operate in conjunction with a treatment plan that likely includes medications, in-person visits, and therapies, among other essential services and interventions. With continued adherence to prescribed treatment and follow-up via DTx, patients may be able to stop or alter parts of their treatment plans if the disease response is favorable.
Diabetes management
Today, clinicians and patients have a variety of DTx options to manage diabetes, including BlueStar®, the DIABEO System, Livongo®, and Tidepool Loop. Each of these applications employ rapid point-of-care management for the treatment of diabetes, but DTx applications have many functions, including peer-to-peer or peer-to-coach interactions, and real-time and individualized recommendations for insulin dosing based on recorded blood sugar values. (Ramakrishnan et al., 2021). For patients managing obesity via lifestyle modifications, digital therapeutics offer an easily accessible and powerful treatment method with the ability to monitor and adjust body weight, food diaries, and glucose and medication adherence.
Cost considerations
The need for digital technologies to aid in the management of chronic diseases has increased significantly in the past several years. The COVID-19 pandemic highlighted the urgency for technologies such as these, as patients were suddenly unable or too fearful to leave their homes for medical care. In 2021, global digital health funding rose to $57.2 billion, a 79% growth over the previous year (Adatia et al., 2023). Much of this funding funnels into digital therapeutics.
Despite an increase in funding for these therapies, insurance coverage is still lagging. Recent surveys show that only about 40% of payers have something in place specifically for digital therapeutics, while 50% of payers don’t have a strategy at all (Asimopoulos, 2022). While insurance companies are still deciding if and how they will cover DTx, in December 2022, Congress introduced a bill to support the coverage of digital therapeutics, stating that this step would “make it easier for clinicians to prescribe innovative new technologies, such as digital health devices and mHealth apps” (Wicklund, 2022).
The cost of digital applications, insurance coverage, and reimbursement is one side of the equation; the flip side shows that employing DTx can reduce healthcare costs by keeping patients out of the hospital and reducing adverse events due to more consistent and comprehensive follow-up via DTx.
Regulatory compliance
The use of DTx is becoming more prevalent; similarly, the regulatory components surrounding the application of these products are still evolving. Digital therapies fall under the Software as a Medical Device (SaMD) category from a regulatory standpoint. Since technology is evolving at warp speed, the parameters surrounding enforcement and regulation still require clarification.
Clinician and patient perspective
According to the Digital Therapeutics Alliance, DTx products “address a range of disease states and provide a wide variety of software-based interventions.” DTx products can benefit clinicians and patients in various ways, for instance, by providing better patient outcomes, saving on costs and time spent in busy clinics, increasing compliance and adherence, and supporting 360-degree patient care. While there is an expected learning curve with new technologies, once patients and clinicians become proficient in their use, DTx platforms can benefit both parties significantly.
The future of digital therapeutics
Healthcare is constantly advancing with the employment of evolving technology. With applications and platforms like DTx, patients can feel empowered to participate in and further their health as they take ownership of their care. Likewise, the current use of DTx in endocrinology provides some of the best use cases for applying DTx technologies to endocrine disorders in the future. Patients can partially manage disease processes from a distance. And with real-time updates on markers such as blood glucose levels and weight fluctuations, clinicians can make up-to-date and accurate changes to therapy plans tailored to each patient.
The future of healthcare is evolving in exciting ways every day, and the DTx treatment options in endocrinology are just the tip of the iceberg for what is to come.
References
Adatia, C., Dreischmeier, R., Shah, S., & Sharma, K. (2023, Jan 27). The health benefits and business potential of digital therapeutics. McKinsey and Company. https://www.mckinsey.com/industries/life-sciences/our-insights/the-health-benefits-and-business-potential-of-digital-therapeutics.
Asimopoulos, M. (2022, March 30). Payer considerations for evaluation, coverage, and reimbursement of digital therapeutics. First Report Managed Care. https://www.hmpgloballearningnetwork.com/site/frmc/conference-coverage/payer-considerations-evaluation-coverage-and-reimbursement-digital.
Digital Therapeutics Alliance. (2023). Trustworthy and effective therapy options. https://dtxalliance.org/value-of-dtx/clinicians/.
Golden, S.H., Robinson, K.A., Saldanha, I., Anton, B., & Ladenson, P.W. (2009). Prevalence and incidence of endocrine and metabolic disorders in the United States: a comprehensive review. Journal of Clinical Endocrinology and Metabolism, 94(6), 1853-1878. https://doi.org/10.1210%2Fjc.2008-2291.
Ramakrishnan, P., Yan, K., Balijepalli, C., & Druyts, E. (2021). Changing face of healthcare: digital therapeutics in the management of diabetes. Current Medical Research and Opinion, 37(12), 2089-2091. https://doi.org/10.1080/03007995.2021.1976737.
Rassi-Cruz, M., Valente, F., Caniza, M.V. (2022). Digital therapeutics and the need for regulation: how to develop products that are innovative, patient-centric and safe. Diabetes and Metabolic Syndrome, 14(48). https://doi.org/10.1186/s13098-022-00818-9.
Wicklund, E. (2022, Dec 16). Senators introduce bill to support coverage of digital therapeutics. Shelley Moore Capito. https://www.capito.senate.gov/news/in-the-news/senators-introduce-bill-to-support-coverage-of-digital-therapeutics.