Truway Diagnostic Tools in Primary Care

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

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 assess glycemic control and safety.

Study 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.

Eligibility

Primary outcome measure(s)

• Rate of Early Detection of Chronic Conditions — 6 months
  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.
• Improvement in Glycemic Control — 6 months
  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.

Trial sites (1)

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