Truway Diagnostic Tools in Primary Care

Part of paid clinical trials in New York, New York.

Sponsor
Truway Health, Inc.
Study ID
NCT07209527
Phase
EARLY_PHASE1
Status
Enrolling By Invitation

Conditions

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

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

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.
  • 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.
  • 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.

Study Details

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.

Key Dates

Start date
Oct 1, 2025
Status verified
Oct 2025
Primary completion
Oct 1, 2028
Completion
Oct 1, 2028

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Intervention Group with Truway Diagnostic Devices
    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.
  • Active Comparator: Control Group with Standard Care
    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.

Primary Outcome Measure

Rate of Early Detection of Chronic Conditions [ Time Frame: 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Truway Health, Inc.New YorkNew York10016-

Find similar trials in New York, NY

By condition
Hypertension (high blood pressure)Peripheral artery disease
By specialty
CardiologyHeart diseaseVascular medicine
By research site
Truway Health, Inc.· New York, NY

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