Page 90 - ITPS-7-4

INNOSC Theranostics and
Pharmacological Sciences Digital therapeutics for obesity management

validated intervention strategies into DTx is crucial for with stringent regulations like General Data Protection
enhancing their efficacy. Regulation and HIPAA is essential to safeguarding
In a study by Strombotne et al., 2 years of virtual sensitive health information. Robust encryption protocols,
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coaching and ketogenic diet led to a significant reduction in anonymization techniques, and transparent data handling
BMI and monthly usage of diabetes medication in diabetic practices are critical for maintaining patient trust and
patients. In addition, involving healthcare professionals, regulatory compliance.
including doctors, nurses, psychologists, and trainers, 4.1.4. Accessibility and equity
in the development of DTx can ensure the reliability and
effectiveness of these interventions. The accessibility of PDTs remains constrained by factors
including cost barriers and varying levels of digital
3.3.1.6. Target populations literacy among diverse populations. Addressing these
Most DTx focusing on lifestyle modifications or eating- disparities requires proactive efforts to reduce costs,
related issues have primarily concentrated on adults. Despite improve user education, and ensure equitable access to
the correlation between childhood/adolescent obesity DTx solutions. Collaboration between stakeholders in
and adult metabolic diseases, there is a notable scarcity healthcare, technology, and policy sectors is essential for
of studies examining DTx interventions in youths. For advancing accessibility and fostering inclusive healthcare
effective treatment of children and young adults, involving delivery through PDTs.
their caregivers or guardians in the intervention process 4.2. Limitations with DTx use in hospital settings
is deemed more effective in achieving positive clinical
outcomes. Similarly, involving families in interventions Despite extensive efforts to develop various types of DTx,
aimed at older adults, who often contend with existing their integration into clinical settings remains incomplete
metabolic or psychiatric conditions, is recommended due to several limitations. Presently, two significant
to enhance the success of DTx approaches. In addition, concerns hindering the scalability and effectiveness of
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clinicians are advised to tailor strategies according to DTx are low user engagement and insufficient efficacy.
specific target symptoms such as major depressive disorder, Next, akin to traditional pharmaceuticals, DTx must
eating disorders, diabetes, or hypertension. undergo RCTs as part of the approval process to
confirm their safety and efficacy before they reach the
4. Challenges and limitations market. However, DTx software can be updated and
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4.1. Challenges adjusted in response to FDA guidance at any time,
unlike traditional pharmaceuticals. Cybersecurity and
4.1.1. Regulatory and approval challenges data rights present additional challenges that hinder
The regulatory landscape for PDTs in obesity management widespread adoption of DTx. One potential solution
presents significant hurdles, varying widely across different involves forming partnerships between industries
regions. Obtaining approval involves navigating complex and academic institutions; for instance, companies
processes that differ in requirements and timelines between developing successful DTx collaborate with academic
jurisdictions. Harmonizing these regulations globally is groups to ensure scientific rigor, in scenarios similar to
crucial for ensuring timely access to innovative therapies how traditional pharmaceuticals are developed.
and fostering broader adoption in healthcare systems.
5. Future directions
4.1.2. User engagement and adherence
The future of PDTs in obesity and diabetes management is
Effective engagement and sustained adherence pose poised for significant advancements, driven by emerging
substantial challenges for PDTs in obesity management. technologies and personalized medicine. Innovations
Issues such as user motivation, interface design, and in technologies such as AI, augmented reality (AR), and
personalized feedback mechanisms influence long-term virtual reality (VR) are set to transform PDTs, offering more
participation. Strategies incorporating behavioral science immersive and engaging interventions. AI can enhance
principles, real-time feedback, and gamification are the personalization of treatment plans by analyzing
being explored to enhance user engagement and promote vast amounts of user data, while AR and VR can create
adherence to PDTs. interactive experiences that make lifestyle changes more
engaging. Wearable technology is also advancing rapidly,
4.1.3. Data privacy and security providing continuous, real-time health data that can be
Concerns regarding the privacy and security of patient seamlessly integrated with PDTs to offer more precise and
data loom large in the adoption of PDTs. Compliance timely interventions.

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