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INNOSC Theranostics and
Pharmacological Sciences Digital therapeutics for obesity management

Lifestyle intervention represents the cornerstone of excluding interventions that rely solely on short message
treatment for obesity. It is a multicomponent strategy services, telephone calls, or online web-based servers. The
that encompasses lifestyle or behavioral training, dietary objective of this mini-review is to evaluate the current state
change, and an increase in physical activity. Apart from and the future potential of prescription DTx (PDTs) in
lifestyle intervention, a few drugs have been approved obesity management.
for the management of obesity, complementing
lifestyle modifications. These drugs such as orlistat, 2. Current landscape of PDTs in obesity
naltrexone/bupropion, liraglutide, lorcaserin, and management
phentermine/topiramate work to strengthen the patient’s 2.1. Definition and scope
urge to modify their eating behaviors and produce an
energy deficit. However, these drugs pose the additional 2.1.1. PDTs
risk of side effects of which the patient should be aware. PDTs include a class of evidence-based, software-driven
Apart from this, nowadays, patients have surgical options, interventions designed to treat, manage, or prevent
such as gastric banding, sleeve gastrectomy, and Roux- medical conditions. Unlike general wellness applications,
en-Y gastric bypass. Since lifestyle intervention is the PDTs require a prescription from a healthcare provider,
central pillar for managing obesity, digital therapeutics underscoring the need for their clinical validation and
(DTx) with their key focus on improving the lifestyle of regulatory oversight. These therapeutic applications
patients are gaining momentum. 3 deliver therapeutic interventions directly to patients using
DTx refer to the application of high-quality software smartphones, tablets, and other digital devices, integrating
programs to prevent, manage, or treat a medical disorder or seamlessly into daily life and offering continuous,
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disease. Recently, DTx has surfaced as a novel strategy for personalized care. The workflow of PDT solutions is
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managing chronic diseases that are amenable to behavioral depicted in Figure 1.
modifications. In response to the COVID-19 public health 2.2.2. Regulatory aspects and approval processes
emergency, the U.S. Food and Drug Administration (FDA)
has relaxed rules to expand access to digital health devices The regulatory landscape for PDTs is rigorous, ensuring that
that can be used for remote monitoring and management these digital interventions meet high standards of safety
of diseases. Table 1 presents various definitions of DTx. and efficacy. In the United States, the FDA plays a pivotal
5
At present, DTx products are mainly applied to conditions role in the approval process of PDTs. The FDA’s Digital
that are modifiable through behavior change, such as Health Software Precertification (Pre-Cert) Program is
obesity and type 2 diabetes mellitus. For instance, Welldoc designed to streamline the evaluation of software-based
Communications offers diabetes management software for medical devices, fostering innovation while maintaining
mobile phones that connects to web-based data analytics, rigorous standards. This program assesses software
creating an interactive platform for real-time information developers based on five excellence principles: product
and analysis between patients and healthcare providers. quality, patient safety, clinical responsibility, cybersecurity
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Other companies in the digital healthcare space for responsibility, and proactive culture. 12
diabetes and weight management include Noom, Livongo, To gain FDA approval, PDTs undergo a comprehensive
Omada, Voluntis, and Lark. evaluation that includes clinical trials to demonstrate their
This mini-review examines evidence-based therapeutic safety and effectiveness. This process is similar to that for
interventions powered by high-quality software programs, traditional pharmaceuticals and medical devices. PDT

Table 1. Definitions of digital therapeutics based on institutions 7

Institute Definition of digital therapeutics
European data protection DTx are evidence-based therapeutic interventions driven by software to prevent, manage, or treat a medical disorder or
supervisor disease. In other words, DTx are patient-facing software applications that help patients treat, prevent, or manage a disease
and that have a proven clinical benefit. 8
Ministry of food and drug DTx are software, which can be used as a medical device to provide evidence-based therapeutic intervention to patients
safety, South Korea for prevention, control, or treatment of medical disabilities and/or diseases. DTx are applied to patients who require
therapeutic intervention. 9
Digital therapeutics DTx deliver medical interventions directly to patients using evidence-based, clinically evaluated software to treat, manage,
alliance and prevent a broad spectrum of diseases and disorders. 10
Abbreviation: DTx: Digital therapeutics.

Volume 7 Issue 4 (2024) 2 doi: 10.36922/itps.4042