The Evolving Role of Prescription Digital Therapeutics in Diabetes Care

Despite tremendous advancements in the treatment of diabetes, the incidence of diabetes continues to soar, with the most recent CDC statistics for diabetes reporting 37.3 million (representing an estimated 11.3% of the US population with 28.7 million diagnosed and 8.5 million undiagnosed and an estimated 96 million individuals are also classified as prediabetic.¹ In addition to medications and lifestyle modifications (diet, exercise, weight loss, smoking cessation, etc) as integral components of diabetes treatments, researchers have also explored the use of digital interventions to improve clinical outcomes among patients with diabetes, and some of these are available via prescription digital therapeutics (PDTs). Studies have also shown that there is a growing use of digital technology in health care as an innovative tool for patient education and the management and routine monitoring of chronic diseases, including diabetes.²

Findings from a recent publication in Applied Science revealed a positive correlation between digital interventions and effective glycemic improvement by encouraging self-management and personalizing treatment plans and goals, potentially improving patient compliance and clinical outcomes.²

The American Diabetes Association Standards of Care in Diabetes 2023 indicates that digital coaching and digital self-management interventions can successfully provide diabetes self-management education and support.³ The use of PDTs continues to expand for various conditions as a valuable tool for managing diabetes. Awareness about the availability and evolving roles of PDTs in diabetes care is critical to expanding their use in clinical practice.

A study published in Current Medical Research and Opinion showed that the use of digital therapeutic applications has the potential to enhance patient compliance, thus promoting improved clinical outcomes, and decrease the health and economic burdens associated with diabetes management by offering the opportunity for patients to actively participate in their care, encourage lifestyle modifications, provide comprehensive medical care, and periodic monitoring of glycemic status based on patient need.⁴

Another study published in the Indian Journal of Occupational & Environmental Medicine listed examples of the advantages of using digital technology for diabetes, including being a cost-effective tool that improves patient accessibility to treatment, provides a patient-centered approach to care, and offers valuable information to clinicians and patients for the management and monitoring of multiple aspects of diabetes including HbA1c, fasting blood glucose and postprandial blood glucose.⁵

In a recent publication by Modern Healthcare entitled, Digital Therapies: The Missing Piece in Diabetes Care, authors indicated that efficacious management of medical conditions such as T2DM and other cardiometabolic conditions are contingent upon modifying lifestyle changes such as diet and exercise.⁶ The authors wrote, “Digital connectivity could provide the missing piece to that puzzle – offering a near ubiquitous, affordable and reactive way to deliver behavioral therapies to people living with conditions that can be mitigated by behavioral changes.”⁶

Examples of PDTs that have been approved or cleared by the US FDA as a component of therapy for diabetes include the following:^7,8

• Insulia Diabetes Management Companion (Voluntis SA)
• IsageRX
• D-Nav system (Hygieia Inc.)
• BlueStar Rx System (WellDoc Inc.)
• Glooko Mobile Insulin Dosing System (Glooko Inc.)
• Go Dose System (Eli Lilly and Company)
• My Dose Coach (Sanofi Inc.)

In a recent publication, authors indicated that the majority of digital platforms are centered on mobile applications for insulin titration and dosing optimization, utilizing technology platforms that are algorithm‐based technologies that can assist clinicians and patients via assessment and routine monitoring of patient data while also providing effective management of diabetes that are also patient-centered.^8,9

In July 2023, the FDA approved AspyreRx™, a prescription digital behavioral therapeutic device designed to provide cognitive behavioral therapy as an adjunctive therapy to other treatments for diabetes in individuals aged 18 years and older with T2DM.10 AspyreRxTM is prescribed in 90-day increments through a mobile application in a weekly, step-by-step process to enhance glycemic control.¹⁰ The approval was based on data from a phase 3 trial (ClinicalTrials.gov Identifier: NCT04886388) comprised of 669 patients with T2DM and an HbA1c of 7 to <11%. The results of the trial were published in Diabetes Care.¹¹ The trial met its primary and secondary endpoints, and results demonstrated considerable reductions in HbA1c levels compared to a control group receiving standard of care and a control app. The researchers indicated that patients in the AspyreRx arm had a considerably lower HbA1c at 90 days compared to the control group.11 Additionally, one in two individuals attained an average HbA1c decrease of 1.3% after 180 days of use, and on average, subjects who used the PDT also experienced improved fasting blood glucose, reduced systolic blood pressure, reduced weight, improved mood, improved quality of life scores, lower medication utilization and fewer diabetes-related risks compared to subjects who did not use the PDTs.¹⁰Click here for more information.

Conclusion

PDTs have the potential to provide an additional tool to foster a patient-centered approach to managing diabetes while also making the patient an active partner in their day-to-day care, which in turn can improve glycemic control and reduce and/or prevent diabetes-related complications. PDTs enable patients to monitor their response to therapies via blood glucose trends, maintain accessible ranges, and improve clinical outcomes. Due to their frequent interactions with patients, pharmacists are well poised to identify patients with diabetes who may be ideal candidates for PDTs approved for diabetes and can be instrumental in augmenting awareness about these valuable tools to aid in managing diabetes.

References

1. Centers for Disease Control and Prevention. National Diabetes Statistics Report website. 2023. Accessed October 5, 2023. https://www.cdc.gov/diabetes/data/statistics-report/index.html
2. Gershoni T, Ritholz MD, Horwitz DL, Manejwala O, Donaldson-Pitter T, Fundoiano-Hershcovitz Y. Glycemic management by a digital therapeutic platform across racial/ethnic Groups: A retrospective cohort study. Applied Sciences. 2023; 13(1):431. https://doi.org/10.3390/app13010431
3. ElSayed NA, Aleppo G, Aroda VR, Bannuru RR, Brown FM, Bruemmer D, et al. On behalf of the American Diabetes Association. Facilitating positive health behaviors and well-being to improve health outcomes: Standards of care in diabetes-2023. Diabetes Care. 2023;46(Supp 1):S68-S96. doi:10.2337/dc23-S005. PMID: 36507648; PMCID: PMC9810478.
4. Ramakrishnan P, Yan K, Balijepalli C, Druyts E. Changing face of healthcare: digital therapeutics in the management of diabetes. Curr Med Res Opin. 2021;37(12):2089-2091. doi:10.1080/03007995.2021.1976737. Epub 2021 Sep 23. PMID: 34511002.
5. Singal AK, Thirumalai R. Digital therapeutics in diabetes: A significant tool to address employees' health and productivity. Indian J Occup Environ Med. 2022;26(4):205-206. doi:10.4103/ijoem.ijoem_309_22. Epub 2022 Dec 24. PMID: 37033746; PMCID: PMC10077718.
6. Appelbaum K. Digital therapies: the missing piece in diabetes care. Modern Healthcare. Published June 1, 2022. Accessed October 4, 2023. https://www.modernhealthcare.com/digital-health/digital-therapies-missing-piece-diabetes-care
7. Wang C, Lee C, Shin H. Digital therapeutics from bench to bedside. NPJ Digit Med. 2023;10;6(1):38. doi:10.1038/s41746-023-00777-z. PMID: 36899073; PMCID: PMC10006069.
8. Phan P, Mitragotri S, Zhao Z. Digital therapeutics in the clinic. Bioeng Transl Med. 2023;3;8(4):e10536. doi:10.1002/btm2.10536. PMID: 37476062; PMCID: PMC10354777.
9. Agarwal P, Mukerji G, Desveaux L, et al. Mobile app for improved self‐management of type 2 diabetes: multicenter pragmatic randomized controlled trial. JMIR Mhealth Uhealth. 2019;7(1):e10321.
10. Better Therapeutics receives FDA authorization for AspyreRx™ to treat adults with type 2 diabetes. Business Wire website. Published July 10. 2023. Accessed October 4, 2023. https://www.businesswire.com/news/home/20230710624673/en/Better-Therapeutics-Receives-FDA-Authorization-for-AspyreRx%E2%84%A2-to-Treat-Adults-with-Type-2-Diabetes
11. Hsia J, Guthrie NL, Lupinacci P, Gubbi A, Denham D, Berman MA, Bonaca MP. Randomized, controlled trial of a digital behavioral therapeutic application to improve glycemic control in adults with type 2 diabetes. Diabetes Care. 2022;45(12):2976-2981. doi:10.2337/dc22-1099. PMID: 36181554; PMCID: PMC9862458.