Truway Diagnostic Tools in Primary Care (TruDxPC)

Truway Health, Inc.

Status and phase: Invitation-only; Early Phase 1

Conditions: Prediabetes; Hypertension; Chronic Disease; Peripheral Artery Disease; Hyperlipidemia; Chronic Kidney Disease (CKD), Stages 3-4 Exercise Tolerance / Functional Capacity Vascular Health / Arterial Stiffness Fatigue in CKD; Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight; Metabolic Syndrome; Cardiovascular Disease Acute

Treatments: Device: Truway Blood Glucose Monitor; Device: Truway Portable Ultrasound Device; Drug: Standard Oral Hypoglycemic Agent

Study type: Interventional

Funder types: Industry

Identifiers

NCT07209527

TRHW-DX-001

Details and patient eligibility

About

This study evaluates the effectiveness of Truway Health-sourced portable diagnostic devices, including ultrasound and blood glucose monitors, in early detection of chronic conditions in outpatient primary care settings. Conducted as a prospective interventional trial, 200 participants will be assigned to use these devices versus standard care over a 6-month period. The primary outcome is improved diagnostic accuracy and patient outcomes. The study, led by Truway Health, Inc., aims to enhance accessible healthcare solutions starting at a New York site, with potential expansion to Miami.

Full description

This prospective interventional study, titled "Evaluation of Truway Health-Sourced Portable Diagnostic Devices for Early Detection of Chronic Conditions in Outpatient Primary Care Settings," is designed to assess the efficacy and usability of Truway Health, Inc.'s portable diagnostic tools-specifically ultrasound and blood glucose monitoring devices-in improving early detection and management of chronic conditions such as diabetes and cardiovascular disease. Conducted by Truway Health, Inc. (www.truwayhealth.com) (www.truwayhealth.com), a leader in e-commerce medical supply distribution, the study leverages the company's expertise to address gaps in affordable, point-of-care diagnostics.The study will enroll 200 participants from a single initial site, the Truway Health Clinical Research Center in New York, NY, with plans to expand to a second site in Miami, FL, pending initial results and enrollment success. Participants, aged 18-75 with risk factors for chronic conditions (e.g., obesity, family history), will be randomly assigned to one of two groups: an intervention group using Truway-sourced devices under supervised primary care protocols, or a control group receiving standard care without these tools. The intervention period will span 6 months, with follow-up assessments at 3 and 6 months to evaluate diagnostic accuracy, patient adherence, and clinical outcomes (e.g., HbA1c levels, early detection rates).The primary objective is to determine whether Truway's portable devices enhance early detection rates compared to standard care, with secondary endpoints including cost-effectiveness, patient satisfaction, and healthcare provider feedback. Data will be collected via electronic health records and patient surveys, analyzed using statistical methods to assess significance (p<0.05). The study adheres to FDAAA 801 requirements, with results intended for public posting on ClinicalTrials.gov upon completion.Led by Principal Investigator Gavin Solomon, MD, President & CEO of Truway Health, Inc., the trial is sponsored by the company with no current U.S. Government funding. Ethical approval from an Institutional Review Board (IRB) is pending, with recruitment targeted to begin February 1, 2026. Challenges include ensuring device calibration across sites and compliance with regulatory reporting timelines. This initiative reflects Truway Health's commitment to innovative healthcare solutions, with findings potentially informing future device distribution and clinical guidelines.

Enrollment: 200 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

Age 18 to 75 years, inclusive

Ability to understand the study procedures and provide written informed consent

Diagnosis of the target condition according to established clinical or diagnostic criteria

Stable treatment regimen (pharmacologic or non-pharmacologic) for at least 4 weeks prior to screening

Willingness and ability to comply with all study visits, procedures, and follow-up assessments -

Exclusion criteria

Pregnancy or breastfeeding at the time of enrollment

Known hypersensitivity to any components of the investigational intervention

Uncontrolled or unstable comorbid conditions (for example, cardiovascular, hepatic, renal, or psychiatric disorders)

Participation in another interventional clinical trial within the past 3 months

Cognitive impairment or language barrier that would preclude valid informed consent or reliable reporting

-

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

200 participants in 2 patient groups

Intervention Group with Truway Diagnostic Devices

Experimental group

Description:

Participants (n=100) will use Truway Health-sourced portable ultrasound and blood glucose monitors under supervised primary care protocols. The intervention aims to enhance early detection of chronic conditions (e.g., diabetes, cardiovascular disease) over 6 months, with follow-ups at 3 and 6 months to assess diagnostic accuracy and clinical outcomes. Devices are calibrated and provided by Truway Health, Inc., with training for care providers.

Treatment:

Drug: Standard Oral Hypoglycemic Agent

Device: Truway Blood Glucose Monitor

Device: Truway Portable Ultrasound Device

Control Group with Standard Care

Active Comparator group

Description:

Participants (n=100) will receive standard care without Truway diagnostic devices, following routine primary care practices for chronic condition management. Outcomes will be compared to the intervention group over 6 months, with follow-ups at 3 and 6 months to evaluate standard diagnostic accuracy and clinical results. No additional devices or training are provided.

Treatment:

Drug: Standard Oral Hypoglycemic Agent

Device: Truway Blood Glucose Monitor

Device: Truway Portable Ultrasound Device