We’re thrilled to launch our first-ever clinical trial of TruDxPc

Study Identification

• Protocol ID: TRHW-DX-001

• Brief Title: Truway Diagnostic Tools in Primary Care

• Acronym: TruDxPC

• Study Type: Interventional

• Official Title: Evaluation of Truway Health-Sourced Portable Diagnostic Devices for Early Detection of Chronic Conditions in Outpatient Primary Care Settings: A Prospective Interventional Study

• Record Verification Date: October 2025

• Recruitment Status: Enrolling by invitation

Timeline

• Study Start Date: October 1, 2025 (anticipated)

• Primary Completion Date: October 1, 2028 (anticipated)

• Study Completion Date: October 1, 2028 (anticipated)

Sponsors & Regulatory Oversight

• Sponsor: Truway Health, Inc.

• U.S. FDA-Regulated Drug: Yes

• U.S. FDA-Regulated Device: Yes (unapproved/uncleared)

• Post Prior to Approval/Clearance: Yes

• Pediatric Postmarket Surveillance: Yes

• IND/IDE: No

• Product Exported from U.S.: Yes

• IRB Review: Exempt

• Data Monitoring Committee: Yes

Brief Summary

This prospective, open-label interventional trial will enroll 200 adults (ages 18–75) at risk for diabetes or cardiovascular disease. Participants at a New York primary care site (with planned expansion to Miami) will be randomized 1:1 to either:

• Intervention Arm: Use Truway Health’s portable ultrasound and blood glucose monitor alongside standard care

• Control Arm: Receive standard primary care diagnostics without Truway devices

Over a six-month period, we will assess whether TruDxPC improves early detection rates, diagnostic accuracy (e.g., HbA1c thresholds, imaging biomarkers), and patient outcomes compared to standard practice.

Objectives & Endpoints

Primary Objective

• Determine sensitivity and specificity of Truway portable devices for early detection of chronic conditions.

Secondary Objectives

• Compare time to diagnosis and clinical workflow efficiency.

• Analyze cost-effectiveness and health economics impact.

• Measure patient adherence and satisfaction.

• Collect clinician usability feedback.

Endpoints

• Primary: Diagnostic accuracy at 6 months (HbA1c change; imaging-detected pathology).

• Secondary: Time to actionable diagnosis; patient satisfaction scores; cost per diagnosis; provider usability ratings.

Study Design

• Model: Parallel assignment, sequential enrollment

• Randomization: 1:1 allocation to Intervention vs Control

• Masking: Open‐label (no masking)

• Enrollment: 200 participants total

• Phases:

  1. Phase 1 (NYC): 100 participants begin Feb 1, 2026

  2. Phase 2 (Miami): Additional 100 participants pending interim analysis (May 2026)

Eligibility Criteria

Inclusion

• Age 18–75

• Risk factors for chronic disease (e.g., obesity, family history)

• Ability to consent and attend study visits

Exclusion

• Pregnancy or breastfeeding

• Uncontrolled comorbidities

• Participation in another interventional trial within 3 months

Arms & Interventions

Intervention Arm (n=100)

• Devices:

  • Truway Portable Ultrasound Device for non-invasive imaging

  • Truway Blood Glucose Monitor for point-of-care glucose testing

• Protocol: Supervised use under primary care visits, device calibration by Truway Health

• Medication: Standard oral hypoglycemic agent (e.g., metformin) as clinically indicated

Control Arm (n=100)

• Standard Care: Routine primary care diagnostics and management without Truway devices

Conditions & Keywords

Conditions: Type 2 Diabetes Mellitus, Hypertension, Cardiovascular Disease, Hyperlipidemia, Chronic Kidney Disease (Stages 3–4), Peripheral Artery Disease, Metabolic Syndrome, Prediabetes, Obesity

Keywords: Portable Diagnostic Devices, Ultrasound, Blood Glucose Monitoring, Chronic Disease Management, Early Detection, Primary Care, Truway Health, TruDxPC, Interventional Study

For more information or for further instructions on how to pre-qualify and entroll, email us at help@truwayhealth.com or call us at +1 (516) 768-5264

PRS (clinicaltrials.gov) Unique Protocol ID: TRHW-DX-001, Acronym: TruDxPC