Digital Therapeutics in Diabetes Show Potential for Improved Disease Management

Results of a recent study suggest that research-evaluated digital therapeutics could improve aspects of diabetes management, including knowledge, physical activity, self-management, mental wellbeing, and hemoglobin A1c (HbA1c).¹ Pharmacists should be aware of these digital therapeutics, which are often used in adjunct with medication, to better understand the treatment outcomes.

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“What's interesting is prescription digital therapeutics have really blown up in the last couple of years. What's been happening is there's actually been over 5000 different studies out there that look at the effectiveness, the outcomes associated with these different types of products. When you look at them, by and large, you're going to find some positive studies, but the problem is, by and large, they have a very small number of patients that are involved with them,” Kari Franson, PharmD, PhD, BCPP, senior associate dean for academic and student affairs and professor of clinical pharmacy at USC Mann, said in an interview.²

Health care technology accessed from personal smart devices has been growing and is expected to be part of a paradigm shift in medicine and health care. Health apps are used to support medical practices or can be used to promote wellness based on prevention or management. In 2022, a federal bill was introduced called Access to Prescribing Digital Therapeutics Act, and was reintroduced in March 2023. The bill provides benefits for prescribing digital therapeutics for Medicare and Medicaid and would be limited to FDA-cleared or FDA-authorized products. There has been no update on the status of the bill.^3,4

In the current study, investigators included digital games or apps with a gaming component that were designed specifically for patients with diabetes. Digital therapeutics were designed either for children or adults or for type 1 diabetes or type 2 diabetes. Investigators identified 5079 articles, but after removing duplicates and excluding articles that did not meet inclusion criteria, 21 articles—including 23 games—were included.¹

The games were played on various platforms, with the most common being mobile phones, personal computers, game consoles, iPad, and personal robot. There were 15 T1D games for children, 7 for adults with T2D, and 1 for adults with T1D. There were several games that were categorized as action-adventure, platform games, quiz games, strategy games, augmented reality games, virtual pet games, role-playing games, and casino games, according to the study authors.¹

The authors identified the effects of the games were separated into 5 domains: HbA1c, diabetes-related education, physical activity, self-management, and mental wellbeing. Two games had a significant reduction in HbA1c­ levels, but the other 5 did not have significant effects onHbA1c­. For knowledge, 4 of 5 of the studies had differences in diabetes-related knowledge compared to the control groups.¹

For physical activity, there were 3 studies, with all 3 resulting in improvements for exercise. For 3 of 4 of the studies used to enhance self-management, self-management had a positive improvement among children and adults. In 3 studies for mental wellbeing, there were improvements in diabetes-related distress, according to the authors.¹

For the digital therapeutics in this study, most applications were readily available to patients. However, for newer therapeutics that would be prescribed, the product should have evidence in benefits and be authorized by the FDA.¹

“The reality is that prescription pretty much bypasses pharmacists. So, the provider will provide the patient the prescription, and then that is essentially a key that unlocks some sort of website for the patient to be able to access the application or the software,” Franson said. “The pharmacist really needs to be aware of what is the place of these digital therapeutics in the entire therapy plan for the patient because most often these are being used in conjunction with pharmaceutical agents that are trying to treat the disorder. They often can be helpful in monitoring improvement in that disease state so that pharmacists having access to that information can be very, very helpful.”²

REFERENCES

1. Reinders EFH, de Vries R, Wouters-van Poppel PCM, Van Riel NAW, Haak HR. Serious digital games for diabetes Mellitus: A scoping review of its current State, Accessibility, and functionality for patients and healthcare providers. Diabetes Res Clin Pract. Published online August 22, 2024. doi:10.1016/j.diabres.2024.111833

2. Pharmacy Times. Prescription Digital Therapeutics for Mental Health: Effectiveness, Challenges, and Future Trends. April 24, 2024. Accessed August 26, 2024. https://www.pharmacytimes.com/view/prescription-digital-therapeutics-for-mental-health-effectiveness-challenges-and-future-trends

3. Antrim A. Despite Lack of Consensus on Definition and Regulations, Digital Therapeutics Are Becoming General Medical Practice. Pharmacy Times. April 26, 2023. August 26, 2024. https://www.pharmacytimes.com/view/despite-lack-of-consensus-on-definition-and-regulations-digital-therapeutics-are-becoming-general-medical-practice

4. Gallagher A. Updates in Federal Legislation Addressing Digital Therapeutics, Access to Care. Pharmacy Times. October 17, 2023. Accessed August 26, 2024. https://www.pharmacytimes.com/view/updates-in-federal-legislation-addressing-digital-therapeutics-access-to-care