200
Participants
Start Date
October 1, 2025
Primary Completion Date
October 1, 2028
Study Completion Date
October 1, 2028
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.
Truway Health, Inc., New York
Truway Health, Inc.
INDUSTRY