Truway Diagnostic Tools in Primary Care

EARLY_PHASE1Enrolling by invitationINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

October 1, 2025

Primary Completion Date

October 1, 2028

Study Completion Date

October 1, 2028

Conditions
Chronic DiseaseType 2 Diabetes Mellitus (T2DM), Obesity, OverweightHypertensionCardiovascular Disease AcuteHyperlipidemiaChronic Kidney Disease (CKD), Stages 3-4 Exercise Tolerance / Functional Capacity Vascular Health / Arterial Stiffness Fatigue in CKDPeripheral Artery DiseaseMetabolic SyndromePrediabetes
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 assess glycemic control and safety.

Trial Locations (1)

10016

Truway Health, Inc., New York

All Listed Sponsors
lead

Truway Health, Inc.

INDUSTRY