TruDxPCPortable Diagnostic Devices for Early Detection of Chronic Conditions
Truway Portable Ultrasound Device
+ Truway Blood Glucose Monitor
+ Standard Oral Hypoglycemic Agent
Urogenital Diseases+36
+ Arterial Occlusive Diseases
+ Arteriosclerosis
Diagnostic Study
Summary
Study start date: October 1, 2025
Actual date on which the first participant was enrolled.This study focuses on evaluating portable diagnostic devices, specifically ultrasounds and blood glucose monitors, to help detect chronic conditions like diabetes and cardiovascular disease early. The goal is to determine if these tools improve early detection and management of such conditions when used in outpatient primary care settings. The study targets adults aged 18 to 75 who have risk factors for chronic conditions, aiming to address the need for affordable and effective diagnostic options. Improving early detection could lead to better management of these conditions, potentially enhancing patient outcomes and reducing healthcare costs. Participants in the study are randomly assigned to one of two groups. One group will use the Truway-sourced devices under the guidance of primary care protocols, while the other will receive standard care without these devices. The trial lasts six months, with follow-ups to measure the accuracy of the devices, patient adherence, and clinical impacts such as blood sugar levels and detection rates. Data is collected through electronic health records and patient surveys to evaluate the effectiveness and satisfaction of the portable devices. This study, led by Truway Health, Inc., aims to provide insights that could shape future diagnostic practices and device distribution.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.200 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Diagnostic Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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 unstable comorbid conditions (for example, cardiovascular, hepatic, renal, or psychiatric disorders) Participation in another interventional clinical trial within the past 3 months Cognitive impairment or language barrier that would preclude valid informed consent or reliable reporting \-
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location