Truway Diagnostic Tools in Primary Care

NCT07209527 | Enrolling By Invitation Early Phase 1 DMC FDA Drug FDA Device

• 1 other identifier: TRHW-DX-001
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Portable Diagnostic Devices; Ultrasound; Blood Glucose Monitoring; Chronic Disease Management; Early Detection; Primary Care; Interventional Study; Truway Health; Diabetes; Cardiovascular Disease; Hypertension; Obesity; Metabolic Syndrome; Outpatient Care; Clinical Trial

Outcome Measures

Primary Outcomes (2)

• Rate of Early Detection of Chronic Conditions

  The percentage of participants with early detection of chronic conditions (e.g., Type 2 Diabetes Mellitus, Cardiovascular Disease) using Truway Health-sourced portable diagnostic devices (ultrasound and blood glucose monitor) compared to standard care. Early detection is defined as identification of abnormalities (e.g., elevated HbA1c ≥5.7%, abnormal ultrasound findings) prior to clinical symptom onset.

  6 months

• Improvement in Glycemic Control

  The change in HbA1c levels among participants with prediabetes or Type 2 Diabetes Mellitus in the intervention group using the Truway Blood Glucose Monitor and standard oral hypoglycemic agent, compared to the control group receiving standard care.

  6 months

Secondary Outcomes (1)

• Patient Satisfaction with Diagnostic Tools

  6 months

Study Arms (2)

Intervention Group with Truway Diagnostic Devices

EXPERIMENTAL

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.

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

Control Group with Standard Care

ACTIVE COMPARATOR

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.

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

Interventions

Truway Portable Ultrasound Device 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.

Control Group with Standard Care; Intervention Group with Truway Diagnostic Devices

Truway Blood Glucose Monitor DEVICE

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.

Control Group with Standard Care; Intervention Group with Truway Diagnostic Devices

Standard Oral Hypoglycemic Agent DRUG

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 assess glycemic control and safety.

Control Group with Standard Care; Intervention Group with Truway Diagnostic Devices

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 -

You may not qualify if:

• 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

Sponsors & Collaborators

• Truway Health, Inc.: lead

Study Sites (1)

Truway Health, Inc.

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Chronic Disease; Diabetes Mellitus, Type 2; Obesity; Overweight; Hypertension; Hyperlipidemias; Renal Insufficiency, Chronic; Peripheral Arterial Disease; Metabolic Syndrome; Prediabetic State; Diabetes Mellitus; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Vascular Diseases; Dyslipidemias; Lipid Metabolism Disorders; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Insulin Resistance; Hyperinsulinism

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Post-Marketing Study: Yes

Model Details: This study employs an Interventional Study Model designed as a parallel assignment with a sequential enrollment approach. Participants (n=200) will be randomly assigned to one of two groups: an intervention group utilizing Truway Health-sourced portable diagnostic devices (ultrasound and blood glucose monitors) under supervised primary care protocols, or a control group receiving standard care without these tools. The parallel assignment ensures simultaneous comparison of outcomes between the groups over the 6-month intervention period.The sequential enrollment strategy involves staged recruitment, beginning with 100 participants at the initial site (Truway Health Clinical Research Center, New York, NY) starting February 1, 2026, followed by an additional 100 participants at a planned Miami, FL site pending successful interim analysis (targeted for May 2026). This phased approach allows for monitoring of device performance and safety data before expanding, with adjustments to protocols

Study Record Dates

• First Submitted: October 1, 2025
• First Posted: October 7, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: October 24, 2025

Record last verified: 2025-10

Locations

US (1)