Truway Health, Inc.
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.
This prospective interventional study, titled "Evaluation of Truway Health-Sourced Portable Diagnostic Devices for Early Detection of Chronic Conditions in Outpatient Primary Care Settings," is designed to assess the efficacy and usability of Truway Health, Inc.'s portable diagnostic tools-specifically ultrasound and blood glucose monitoring devices-in improving early detection and management of chronic conditions such as diabetes and cardiovascular disease. Conducted by Truway Health, Inc. (www.truwayhealth.com) (www.truwayhealth.com), a leader in e-commerce medical supply distribution, the s…
Inclusion Criteria: 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 - Exclusion Criteria: Pregnancy or breastfeeding at the time of enrollment Known hypersensitivity to any components of the investigational intervention Uncontrolled or unsta…
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.
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.
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.