Truway Diagnostic Tools in Primary Care

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

Overview

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.

Detailed 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.

Interventions

• Device Truway Portable Ultrasound Device
  Participants in the intervention group will use the Truway Portable Ultrasound Device, a FDA-regulated diagnostic tool, to perform non-invasive imaging for early detection of chronic conditions such as cardiovascular disease. The device will be used under supervised primary care protocols over a 6-month period, with training provided to care providers. Calibration and maintenance will be managed by Truway Health, Inc.
• Device Truway Blood Glucose Monitor
  Participants in the intervention group will utilize the Truway Blood Glucose Monitor, an FDA-regulated device, to measure blood glucose levels for early detection and management of diabetes. The device will be employed under supervised primary care protocols over 6 months, with follow-ups at 3 and 6 months to assess accuracy and clinical outcomes. Training and support will be provided by Truway Health, Inc.
• Drug Standard Oral Hypoglycemic Agent
  Participants in the intervention group with diagnosed prediabetes or Type 2 Diabetes Mellitus may receive a standard oral hypoglycemic agent (e.g., metformin) as prescribed by their primary care provider, in conjunction with the Truway diagnostic devices. The drug will be administered according to FDA-approved guidelines over the 6-month study period, with dosages adjusted based on blood glucose monitoring results obtained from the Truway Blood Glucose Monitor. Follow-ups at 3 and 6 months will

Primary outcome measures

• Rate of Early Detection of Chronic Conditions [Time frame: 6 months]
• Improvement in Glycemic Control [Time frame: 6 months]

Secondary outcome measures (1)

• Patient Satisfaction with Diagnostic Tools [Time frame: 6 months]

Eligibility criteria

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

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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Sequential

Masking

Open label

Primary purpose

Diagnostic

Study locations

United States · 1 center

• Truway Health, Inc. — New York

Identifiers

NCT: NCT07209527 · TRHW-DX-001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗