Digital therapeutics

Digital therapeutics, a subset of digital health, are evidence-based therapeutic interventions driven by high quality software programs to prevent, manage, or treat a medical disorder or disease.[1][2][3][4][5] Digital therapeutic companies should publish trial results inclusive of clinically meaningful outcomes in peer-reviewed journals.[6] The treatment relies on behavioral and lifestyle changes usually spurred by a collection of digital impetuses.[7][8] Because of the digital nature of the methodology, data can be collected and analyzed as both a progress report and a preventative measure.[9][10][11][12][13][14] Treatments are being developed for the prevention and management of a wide variety of diseases and conditions, including type II diabetes, congestive heart failure, obesity, Alzheimer's disease, dementia, asthma, substance abuse, ADHD, hypertension, anxiety, depression, and several others.[2][15][16][17][18] Digital therapeutics often employ strategies rooted in cognitive behavioral therapy.[19][20][21]

Definitions

Although digital therapeutics can be employed in numerous ways, the term can broadly be defined as a treatment or therapy that utilizes digital and often Internet-based health technologies to spur changes in patient behavior.[4][22] The use of digital products to improve health outcomes dates as far back as 2000.[10][3] The term itself has been in use since around 2012.[23] The first mention of the term in a peer-reviewed research publication was in 2015, in which Dr. Cameron Sepah formally defined the field as: "Digital therapeutics are evidence-based behavioral treatments delivered online that can increase accessibility and effectiveness of health care."[7] Digital therapeutics can be used as a standalone therapy or in conjunction with more conventional treatments like pharmacological or in-person therapy.[4][19] As of 2018, digital therapeutics continues to be an evolving field that medical professionals, students, and patients are beginning to utilize.[24]

The Digital Therapeutics Alliance states: "Digital therapeutics (DTx) deliver evidence-based therapeutic interventions to patients that are driven by high quality software programs to prevent, manage, or treat a broad spectrum of physical, mental, and behavioral conditions."[25] Digital therapeutics are different from wellness apps or medication reminders in that they require rigorous clinical evidence to substantiate intended use and impact on disease state.

It is often used as a preventive measure for patients who are at risk of developing more serious conditions. For instance, a patient with prediabetes may be prescribed digital therapeutics as a method to change their diet and behavior that could otherwise lead to a diabetes diagnosis.[7][2][16][21] Digital therapeutics can also be used as a treatment option for existing conditions. For instance, a patient with type II diabetes can use digital therapeutics to manage the disease more effectively.[2][7][16]

The methodology uses a variety of digital implements to help manage, monitor, and prevent illnesses in at-risk patients. These include mobile devices and technologies, apps, sensors, desktop computers, and various Internet of Things devices.[26] These implements can collect a wide variety of data, ranging from big to small. Digital therapeutics can theoretically collect a high volume of data from a variety of sources. It also collects "smaller" data, "capturing personalized physiological parameters, behavior patterns and social and geographical patterns that can be recorded from multiple digital sources."[9]

Methodologies

Digital therapeutics can be used for a variety of conditions. There is no single methodology used in the practice of digital therapeutics. It uses methods rooted in cognitive behavioral therapy to spur patients to make lifestyle changes. The method can be used to manage and prevent numerous conditions, including type II diabetes, Alzheimer's disease, dementia, congestive heart failure, chronic obstructive pulmonary disease, asthma, lung disease, obesity, substance abuse, ADHD, insomnia, hypertension, anxiety, depression, and others.[2][17][18][12]

Methodologies can be as simple as sending notifications designed to alter behavior to patients who are at risk of obesity or diabetes[16][2] and as complex as administering an ingestible radio tag that communicates with an external sensor to monitor the efficacy of a given medication.[4] Diabetes and obesity prevention and management is a major focus in the field of digital therapeutics.[27][11] Connected devices like insulin pumps, blood glucose meters, and wearable gadgets can all send data to a unified system. The therapy also uses self-reported data like diet or other lifestyle factors.[2][7] It is also often used to monitor the potential for heart and lung conditions and change behaviors like smoking, poor diet, or a lack of exercise.[26][2]

Digital therapeutics can also be used to treat patients with psychological and neurological symptoms. For example, patients with disorders like ADHD, depression, and anxiety can receive cognitive behavioral therapy via their mobile devices.[19] One study looked at the efficacy of avatar-based therapeutic interventions to reduce depressive symptoms.[15] Another study analyzed seven clinical trials to demonstrate the efficacy of a digital therapeutic in significantly reducing blood pressure.[17] A preliminary study suggested that a mobile mindfulness app may be able to decrease acute stress while improving mood. [28]

Outcomes

The general consensus among researchers in the field of digital therapeutics is that the discipline requires more clinical data and investigation to be fully evaluated.[3][24] A variety of studies have been conducted to evaluate the efficacy and impact of behavior change techniques that utilize a digital platform, however.[7][3][12][27] In a meta-analysis of 85 such studies comprising a total sample size of over 43,000 participants, researchers discovered that digital therapeutics have a "statistically small but significant effect on health-related behavior." The study also showed that a broader use of theory, behavior change techniques, and modes of delivery (especially regular notifications) improved the efficacy of a given program.[3]

Individual studies have also showed some benefits for patients. For instance, a diabetes prevention program using digital therapeutics saw participants lose an average of 4.7% of baseline body weight after 1 year (4.2% after 2 years) and undergo a 0.38% reduction in A1c levels after 1 year (0.43% after 2 years).[7] Another weight loss pilot program using digital therapeutics reported a mean weight loss of 13.5 pounds (or 7.3% of baseline) with a significant average drop in both systolic and diastolic blood pressure (18.6 mmHg and 6.4 mmHg respectively). The study also saw a slight but statistically insignificant drop in total cholesterol, LDL, triglycerides, and A1c.[27]

See also

References
  1. https://www.dtxalliance.org/dtxproducts/
  2. Kvedar, Joseph C.; Fogel, Alexander L.; Elenko, Eric; Zohar, Daphne (March 2016). "Digital medicine's march on chronic disease" (PDF). Nature Biotechnology. 34 (3): 239–246. doi:10.1038/nbt.3495. PMID 26963544. Retrieved 19 October 2016.
  3. Webb, Thomas L.; Joseph, Judith; Yardley, Lucy; Michie, Susan (17 February 2010). "Using the Internet to Promote Health Behavior Change: A Systematic Review and Meta-analysis of the Impact of Theoretical Basis, Use of Behavior Change Techniques, and Mode of Delivery on Efficacy". Journal of Medical Internet Research. 12 (1): e92. doi:10.2196/jmir.4052. PMC 4409647. PMID 25863515. Retrieved 21 October 2016.
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  6. https://www.dtxalliance.org/wp-content/uploads/2018/09/DTA-Report_DTx-Industry-Foundations.pdf
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