TatvaCare Clinical Trials: Advancing Digital Health

At TatvaCare, we are dedicated to validating the impact of our digital therapeutics on patient health through rigorous clinical trials, we test and refine our solutions, ensuring they meet the highest standards of efficacy and safety.

Each study is designed to produce measurable, scientifically-backed results that support better health outcomes for chronic conditions such as Diabetes, Obesity, COPD, and more

Why Clinical Trials are Important for DTx?

Digital therapeutics provide innovative solutions for chronic conditions, but their potential must be validated with robust evidence. At TatvaCare, we conduct these trials not just to prove efficacy and safety but to refine and optimize our MyTatva care programs.

These studies allow us to:

  • Personalize Care More Effectively: By studying diverse populations, we gather insights to tailor MyTatva interventions for individual patient needs.
  • Measure Real-World Impact: Our trials help us validate that MyTatva care programs improve health outcomes in everyday settings.
  • Build Trust and Credibility: With scientifically-backed results, healthcare providers and patients can confidently adopt MyTatva as a reliable tool in managing chronic conditions.

Every trial reflects our dedication to improving lives through digital, patient-centric solutions.

Clinical Trial Process: Transforming Insights into Care

Our trials are not just about data; they are about advancing the care journey for every MyTatva user. Here’s how we ensure excellence in our process:

1

Protocol Development

Each trial is guided by a detailed protocol that outlines objectives, methods, and assessment criteria.

2

Sampling and Participant Selection

We select participants who represent real-world users of MyTatva. This diversity helps us refine personalized care plans, ensuring they are effective across varying demographics and health conditions.

3

Intervention Design

Our digital therapeutic interventions, tailored to each participant, include personalized diet and exercise plans, virtual consultations with our in-house healthcare professionals, and access to real-time support.

4

Data Collection and Monitoring

We use both patient-reported outcomes and data from wearables (like smartwatches and BCA devices) to gather objective and reliable health data.

5

Outcome Measurement and Analysis

Health metrics and vitals are tracked over time to evaluate the impact of interventions. Statistical analysis helps us interpret results and verify clinical benefits.

Ethical Standards and Regulatory Compliance

At TatvaCare, our commitment to ethics and safety drives every clinical trial. We adhere to national and international research standards, ensuring patient privacy and data security. Each trial is reviewed by institutional ethics committees to maintain the integrity of our research and the trust of our participants.

Patient-Centric Approach to Clinical Trials

Our clinical trials are designed to prioritize patient comfort, convenience, and transparency. Here’s how we support our participants:

Informed Consent

We ensure that all participants fully understand the study details, including potential benefits, risks, and their rights. Each participant is guided through the consent process before beginning the trial.

Support and Accessibility

Participants have access to ongoing support through virtual consultations with TatvaCare’s in-house team, regular check-ins, and progress tracking.

User-Friendly Technology

The MyTatva app and integrated wearable devices make health management easy and engaging. Participants can track their own progress and stay informed about their health improvements, fostering a sense of achievement and motivation.

Our Vision for the Future of Healthcare

Our clinical trials go beyond validation—they pave the way for the future of healthcare. MyTatva programs are designed to create a paradigm shift in chronic and metabolic condition management, empowering patients to take charge of their health.

Through continuous research and innovation, we aim to integrate digital therapeutics into mainstream care, making personalized health management accessible to all. Our trials are a testament to our unwavering commitment to improving patient lives through science and technology.

Product (Code) Indication Discovery Development Study Publication
RESET (MyT001) Non Alcoholic Fatty Liver Disease (NAFLD)

Discovery

GLIDE (MyT002) Diabetes

Discovery

BREATHE (MyT003) Chronic Obstructive Pulmonary Disease (COPD)

Discovery

MyT004 Metabolic Disorder

Discovery

MyT005 Hypertension

Discovery

MyT006 Dyslipidemia

Discovery

MyT007 Congestive Heart Failure (CHF)

Discovery

MyT008 Uterine Fibroid

Discovery

MyT009 Breast Cancer

Discovery

MyT010 Obesity

Discovery

MyT011 Polycystic Ovary Syndrome (PCOS)

Discovery

MyT012 Prostate Cancer

Discovery

MyT013 Male sexual wellness

Discovery

MyT014 Woman health

Discovery

MyT015 Endometriosis

Discovery

BREATHE DTx

Board of Respiratory Experts for Advanced Therapeutic Health Ecosystem

Objective

To understand the impact of lifestyle modification in diet and exercise delivered by MyTatva application in the management of patients with COPD.

11 Sites

50 Participants

12 weeks

Population

Adults over 40 with moderate to severe COPD, FEV1 between 40% and 80%, no exacerbations in the past 12 months.

EC: Independent Ethics Committee approval with Protocol number C2A03255
CTRI: CTRI/2023/09/057886
MyT program: BREATHE
Devices: Digital Spirometer (Alveofit), Wearable fitness tracker

Outcomes Measured

Clinical Outcomes:

FEV1: Mean increase of 0.062 L

FVC: Mean increase of 0.115 L

Distance Covered in 6-Minute Walk: Mean increase of 118.95 meters

Quality of Life Outcomes:

St. George’s Respiratory Questionnaire (SGRQ) Total Score: Mean reduction of 14.98 points

COPD Assessment Test (CAT) Score: Mean reduction of 3.24 points

RESET DTx

Reducing liver inflammation through Exercise Sleep and Eating Transformation

Objective

To assess the impact of lifestyle modifications, including diet, exercise, and Cognitive Behavioural Therapy (CBT), delivered by the MyTatva application in managing patients with Non-alcoholic Fatty Liver Disease (NAFLD).

3 Sites

22 Participants

12 weeks

Population

Patients with NAFLD, BMI between 25 kg/m² and 40 kg/m², willing to use digital health tools

EC: Independent Ethics Committee approval with Protocol number MTNAFLD120324
CTRI: CTRI/2024/07/070859
MyT program: RESET
Devices: Body Composition Analyzer (BCA), Smartwatch

Outcomes Measured

Clinical Outcomes:

Weight: Mean reduction of 6.99 kg

BMI: Mean reduction of 2.18 kg/m²

Muscle Mass: Mean reduction of 0.72 kg

Subcutaneous Fat: Mean reduction of 1.26%

Visceral Fat: Mean reduction of 2.16%

Quality of Life Outcomes:

Increased consumption of nutrient-rich foods like fruits, vegetables, and lean proteins

Significant reduction in refined foods, fried foods, sweets, highsalt snacks, and restaurant meals, contributing to healthier dietary habits

GLIDE DTx

Glycemic Lifestyle Intervention in Diabetes Empowerment Program

Objective

To assess the impact of lifestyle modifications, including diet, exercise, and Cognitive Behavioural Therapy (CBT), delivered by the MyTatva application in managing patients with Non-alcoholic Fatty Liver Disease (NAFLD).

1 Site

27 Participants

12 weeks

Population

Patients with Type 2 Diabetes Mellitus (T2DM), HbA1c >6.5%, aged 18 or older

EC: Independent Ethics Committee approval with Protocol number MTD120324
CTRI: CTRI/2024/08/071850
MyT program: GLIDE
Devices: Body Composition Analyzer (BCA), Smartwatch

Outcomes Measured

Clinical Outcomes:

HbA1c Reduction: Reduced by an average of 0.99%

Fasting Blood Sugar: Decreased by an average of 54.46 mg/dL

Postprandial Blood Sugar: Decreased by 124.62 mg/dL

Total Cholesterol: mean reduction of 2.07 mg/dL

Weight: mean reduction of 2.84 kg

BMI: mean decrease of 1.21 kg/m²

Body Fat Percentage: mean reduction of 1.37%

Triglycerides: mean reduction of 1.3 mg/dL

Quality of Life Outcomes:

Improvement in lifestyle adherence, reduced frequency of eating out, enhanced engagement with personalized health interventions