Digital therapeutics (DTx) is a new concept of medical technology that has emerged in foreign countries in recent years, and has developed rapidly during the new crown pneumonia epidemic. The core of digital therapy is the prevention, treatment and management of specific diseases driven by highly intelligent medical software.
In April 2020, the U.S. Food and Drug Administration (FDA) issued emergency approval guidance for digital therapeutics for the treatment of mental illness, significantly accelerating the availability of DTx products Approval and speed to market [1].
my country’s National Medical Products Administration (NMPA) also opened a digital therapy approval channel in 2020.
What is digital therapy?
The Digital Therapeutics Alliance defines DTx as: evidence-based, clinically proven software for the treatment, management and prevention of disease[2].
In terms of product form, the core of DTx is computer software, which can be used with hardware, but the core functions are driven by software.
Digital therapy has applications in the fields of psychiatry, nervous system, respiratory system, endocrine, cardiovascular, ophthalmology, skin, digestive system and other diseases. Among them, the intervention, treatment and management of chronic diseases and psychiatric diseases are the most important application areas of digital therapy.
Two important features of digital therapy
DTx is still essentially a combination of computer technology and medical technology, but compared with the well-known digital medical and smart medical care, DTx also has two important characteristics[3]:
It is a disease-specific intervention
Its efficacy is evidence-based
DTx can be divided into three categories: prevention, treatment, and management according to its technical principles and its role in disease intervention, covering three important scenarios in the evolution of a patient’s condition.
Prevention products, mainly aimed at users who have not occurred but belong to high-risk groups, can effectively prevent the occurrence of diseases by providing detection functions and preventive measures.
In January 2016, NeuroTrack launched a product called Neurotrack Imprint, which uses eye tracking technology to identify the extent of damage to the hippocampus in the human brain, allowing earlier detection of patients Whether there is a risk of cognitive decline, once identified, Neurotrack will propose treatment options such as diet, exercise, sleep, stress management and cognitive training, which can help promote the prevention and prevention of cognitive impairment diseases such as Alzheimer’s disease. treat.
(Image source: neurotrack official website)
(Image source: neurotrack official website)
Aiming at the management of inhaled drug doses in patients with chronic lung disease, Propeller Health of the United States has developed a respiratory health management application product. The product has a matching hardware, which is a small sensor that fits into the top of the inhaler. Every time a patient with bronchial asthma or chronic obstructive pulmonary disease uses the device, the sensor will collect a large amount of data, send it to the mobile APP, and then collect it in the background. The algorithm will perform big data mining, and then accurately push the personalized diagnosis and treatment recommendations to the user [4] , 5].
(Photo source: propeller health official website)
These products are mainly used in the fields of neurological, psychological and rehabilitation medicine. The products themselves are part of the treatment plan and can produce definite therapeutic effects after the patient’s use. Such products usually use DTx-loaded software or hardware products to intelligently interact with patients through algorithms to improve patients’ cognition and behavior, thereby achieving therapeutic effects.
In 2017, the US FDA approved the first DTx software for the treatment of drug addiction, ReSET, allowing it to be marketed in prescription form as an adjunctive treatment for drug addiction[6] , the software developed by Pear Therapeutics, a leader in digital therapeutics, was pre-marketed in a 12-week, 399-patient clinical multicenter study.
Study results show higher rates of alcohol and marijuana withdrawal in patients using the product compared to a control group (not using ReSET)40.3% (17.6% in the control group), and no related adverse reactions occurred.
Due to the novelty of this product, the FDA adopted a “de novo premarket review” approval pathway. This event is seen as a milestone for DTx to officially enter the public eye.
(Image credit: Pear Therapeutics product ReSETTM)
In June 2020, the US FDA approved the marketing of a video game called EndeavorRx for the treatment of attention deficit hyperactivity disorder in children aged 8-12 [7]. The product has been shown in multiple clinical studies to significantly improve children’s attention scores and academic performance without serious adverse reactions. EndeavorRx thus became the first video game backed by clinical randomized controlled trial data and officially approved for medical prescription.
(Image source: EndeavorRx page)
The EndeavorRx game’s core technology is the Selective Stimulus Management Engine (SSMETM) software, which utilizes video game-specific sensory stimuli and motor challenges to activate the nervous system through the human senses to improve patient perception. know function. This game uses artificial intelligence to adjust the difficulty of the game in real time, that is, the “dose” is adjusted in real time, from one “dose” to the next “dose”, from one patient to another, it is different. Dosing varies from person to person, which is also an advantage of digital therapy.
Management products are mainly used for patients with a clear diagnosis. By guiding patients to self-manage the conditions and factors that affect the progression of the disease, improve patient compliance, thereby improving the treatment effect, controlling the disease, reducing complications, etc.
Voluntis’ digital therapy product, Oleena software, is FDA-authorized for managing oncology-related symptoms and monitoring patients remotely. By analyzing and judging the symptoms of cancer patients, we provide patients with self-management of adverse reactions during tumor treatment and guidance for timely medical treatment.
(Photo source: oleena official website)
(Photo source: oleena official website)
In China, the small shell application (application, APP) jointly developed by Zhilan Health and Professor Hou Jinlin of Southern Medical University is a hepatitis B mother-to-infant block management software designed on the basis of standardized clinical pathways , you can manage the pregnancy and delivery process of the target object through the mobile APP.
The small shell consists of a patient end and a doctor end. The modules on the patient side include pregnancy tracking reminders, hepatitis B knowledge base, online communication, and electronic medical records. The modules on the doctor side include diagnosis and treatment advice, focus, patient management, online communication, and data statistics. Through the collection, management and analysis of the detection indicators, clinical manifestations and pregnancy information of pregnant women infected with hepatitis B virus, the product provides clinicians with auxiliary diagnosis and treatment suggestions and improves patient compliance.
Studies show that the use of this software can increase the success rate of preventing mother-to-child transmission of hepatitis B to 99.7%. As a result, the Little Shell APP was successively approved by the China National Medical Products Administration for the medical device registration certificate and production license in 2019 and 2020, becoming the first DTx product approved for marketing in the field of liver disease [8,9].
In November 2020, my country’s self-developed Shukang APP was approved for marketing by the China National Medical Products Administration. It was directly issued by doctors as a prescription for patients, which opened the prelude to China’s digital therapy. .
(Photo source: Shukang official website)
Shukang APP focuses on the improvement of cardiorespiratory endurance, and performs exercise assessment and treatment for chronic diseases. It is mainly used for the treatment and prevention of chronic diseases related to the decline of cardiorespiratory endurance, including common endocrine and metabolic diseases. , cardiovascular diseases, tumors, some respiratory diseases and other at least 26 chronic diseases, as well as hypertension, diabetes, hyperuricemia, metabolic syndrome, chronic heart failure, coronary heart disease, atrial fibrillation, colorectal cancer, breast cancer , chronic obstructive pulmonary disease, and post-discharge intervention for patients with new coronary pneumonia.
In the past few years, innovation in China’s digital health sector has been largely in its infancy, with a focus on “connection” functions. 2021 is hailed as the first year of digital therapy in China, and digital therapy begins to truly enter the medical field to provide auxiliary interventions for diseases.
The development prospect of digital therapy in China is very broad, but it also faces challenges. Compared with the United States and other countries where digital therapy is relatively mature, the definition, scope and application scenarios of digital therapy have not yet been established in China. give a clear definition. As the concept gains popularity and confidence in it grows, it is believed that digital therapeutics can play a key role in reducing the prevalence of chronic diseases and leading to more preventative holistic care.
Reviewer: Bo Shining
Deputy Chief Physician, Department of Critical Care Medicine, Peking University Third Hospital
References
[1]U.S. Food & Drug Administration. Digital health innovation action plan[EB/OL]. [2021-06-30].https:https://www.fda.gov/ media/106331/download.
[2]Digital Therapeutics Alliance. A new category of medicine[EB/OL]. [2021-06-30].https:https://dtxalliance.org/understanding-dtx/ .
[3] Tong Qingxia. Current status and future of digital therapy[J]. Chinese Journal of Cardiovascular Diseases (Online Edition), 2021, 04(1): 1-5. DOI: 10.3760 /cma.j.cn116031.2021.1000085.
[4]SickleDV, BarrettM, HumbletO, et al. Randomized, controlled study of the impact of a mobile health tool on asthma SABA use, control and adherence[J]. EUR RESPlR J, 2016, 48(suppl 60): PA1018. DOI: 10.1183/13993003.congress-2016.PA1018.
[5]MerchantR, SzeflerSJ, BenderBG, et al. Impact of a digital health intervention on asthma resource utilization[J]. World Allergy Organ J, 2018, 11(1):28. DOI: 10.1186/s40413-018-0209-0.
[6]U.S. Food & Drug Administration. FDA permits marketing of mobile medical application for substance use disorder[EB/OL]. (2017-09-14)[2021-06-30] . https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-mobile-medical-application-substance-use-disorder.
[7]U.S. Food & Drug Administration. FDA permits marketing of first game-based digital therapeutic to improve attention function in children with ADHD[EB/OL].(2020-09-15) [2021-06-30].https:https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-first-game-based-digital-therapeutic-improve-attention-function- children-adhd.
[8] China Hepatitis Prevention and Control Foundation, Chinese Medical Association Infectious Diseases Branch, Chinese Medical Association Hepatology Branch. Clinical management process of hepatitis B mother-infant interruption [J]. Chinese Journal of Liver Diseases, 2017, 25(4): 254-256. DOI: 10.3760/cma.j.issn.1007-3418.2017.04.004.
[9] Liver Disease Branch of Chinese Medical Association. Consensus on clinical management of women of childbearing age infected with hepatitis B virus[J]. Chinese Journal of Hepatology, 2018, 26(3):204-208. DOI: 10.3760/cma.j.issn.1007-3418.2018.03.009.
Author: Yu Jia
Editors: Ye Yichu, Wu Jiaxiang, Ye Zhengxing
Proofreading: Wu Yihe | Typesetting: Li Yongmin
Operation: Han Ningning | Coordinator: Ye Yichu