Digital

Therapeutics
Modules for
Hypertension

MADE BY : DR. KAVERI NIKAM

 DIGITAL THERAPEUTICS IN HYPERTENSION
 Hypertension continues to be a major contributor to global morbidity and mortality, fueled by an abundance of patients with
uncontrolled blood pressure despite the multitude of pharmacological options available. This may occur as a consequence
of true resistant hypertension, through an inability to tolerate current pharmacological therapies, or non-adherence to
antihypertensive medication. In recent years, there has been a rapid expansion of device-based therapies proposed as
novel non-pharmacological approaches to treating resistant hypertension.

 Digital therapeutics is a new approach to treat hypertension via using software  programs such as smartphone apps and/or
device algorithms. It helps users to promote lifestyle modifications in conjunction with  medically validated non-
pharmacological interventions. The app can assess the  personalities, behavior characteristics, and hypertension
determinants of each patient with hypertension to provide adequate guidance.

The management of hypertension is to lower the target BP to <130/80 mmHg

 Reductions of systolic BP by 10 mmHg and diastolic BP by 5 mmHg  have been shown to reduce stroke and heart failure
by 25%, and coronary artery disease and total mortality by 15%. Both early BP control and lower BP control over 24-hour
are essential to achieve  “zero” CVD events
Patient User Interface :
Hypertension Management
Educational Insights Plan
Articles & Videos for patient
guidance
01 04 A proposed program will be
generated & sent to the doctor.

Prescription
Life Style & Wellness Tracker With the hypertension management plan
Exercise, sleep, walk, water intake,
diet, smoking , alcohol
consumption etc.
02 05 doctor will even generate prescription (if
required) from near by patient’s pharmacy.

Patient Records & Risk

Assessment
Case history including family
history, allergies etc.
03
Doctor’s Follow up Records
06 Timely intervention and follow to
control the blood pressure levels.
Health Analytics of the patient
Doctor’s Interface: What is High Blood Pressure ?

● Digital diary/ Digital Notes should be generated for the doctor in

concise form
● User Progress
● Dashboard should show all the vitals along with history
● Easy connect between Doctor- Patient must be present.

Try these physical activities to reduce your blood pressure:

• Take a 10-15 min walk each day
• Consume low fat, low cholesterol options for lunch

Did you know that the more alcohol you drink, the higher your blood
pressure? good news is that by reducing your alcohol intake, ideally to less
than 2 drinks per day, you can effectively lower your BP.
Digital Therapeutics IoT Segmentation

By Component

Medical Systems and

Services
Devices Software

Remote Device
Management System Integration
Wearable Stationary Implanted Network Services
medical Medical Medical Bandwidth Consulting,
devices devices Devices
Application Training, And
Security Education
Data Analytics Support And
Network Security Maintenance
Services
Digital Therapeutics IoT Segmentation

 Wi-Fi
 Bluetooth Low Energy
 Cellular
By
Technology  Satellite

 Clinical Research Organizations

 Hospitals And Clinics
 Research And Diagnostic Laboratories
By End-User  Others

•Telemedicine
•Medication Management
•Clinical Operations
By •Inpatient Monitoring
Application • Connected Imaging
 A) Wearable Medical Devices for Hypertension
These wearable medical devices have censors which continuously track the activity and monitor the blood pressure.
 Smart Phone App
 Smart Watch

Application has the following 3 stages to ensure the life style modification :

Clinical evidences:
 Reduced salt intake,
 exercise or smoking cessation,
 to lower their BP based on the knowledge
Finally, in Step 3, the app encourages users to create their own strategies to lower their BP by combining some of the non-pharmacological
interventions learned in Step 2. Users will also be encouraged to evaluate and review the process and results of their individually devised plans.
Through this process, the app will allow the lifestyle plans devised by users to take root and realize the necessary behavioral changes  to reduce
BP.
 B) Stationary Medical Devices

Patient will feed base line characteristics including age, sex, gender & behavioral pattern with the help of virtual
assistant followed by home monitoring BP machine & data will be transferred to the data server/cloud via
Bluetooth or Wi-Fi. The progress on the program will be shown to the healthcare providers.
C) Implanted Medical Devices

• BackBeat CNT (Cardiac Neuromodulation Therapy), is an new approach to device-

based blood pressure management and has potential to be a primary treatment
modality for the more than two-thirds of pacemaker patients at risk from hypertension.

• High blood pressure is typically treated using drugs, but BackBeat allows even
existing cardiac implants to deliver therapy in a novel way by modulating the
bioelectronic signals associated with blood pressure control.

• It lowers BP while simultaneously modulating Autonomic Nervous System

(ANS)
-Mimics effects of multiple medications by reducing preload, afterload and
sympathetic tone
Pacemaker-Like Implant
Cleared in Europe to Lower
Blood Pressure
Limitation of Digital therapeutics

One of the biggest ones being the challenge to prove

validity until paired with clinical evidence. However, a
large number of companies follow four primary methods
for validation. These include FDA approval or clearance
for use, registered clinical trials, observational studies or
clinical trials, and Retroactive studies.
REFERENCES
Blood Pressure Lowering Treatment Trialists' Collaboration. Blood  Pressure
Lowering Treatment Trialists C. Blood pressure-lowering  treatment based on
cardiovascular risk: a meta-analysis of individual patient data. Lancet.
2014;384(9943):591-598. 

Kario, Kazuomi, Akihiro Nomura, Noriko Harada, Tomoyuki Tanigawa, Ryuhei So,
Kiyose Nakagawa, Shin Suzuki, Ayako Okura, Eisuke Hida, and Kohta Satake. "A
multicenter clinical trial to assess the efficacy of the digital therapeutics for essential
hypertension: Rationale and design of the HERB ‐DH1 trial." The Journal of Clinical
Hypertension 22, no. 9 (2020): 1713-1722.

Kaźmierczak, Jarosław, and Krzysztof Narkiewicz. "Cardiac Neuromodulation

Therapy–a novel device-based therapy for patients with hypertension and indications
for pacing."

THANK YOU