Enrolling by invitation
TruDxPC

Portable Diagnostic Devices for Early Detection of Chronic Conditions

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Truway Portable Ultrasound Device

+ Truway Blood Glucose Monitor
+ Standard Oral Hypoglycemic Agent
Device
Drug
Who is being recruted

Chronic Disease
+6

+ Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
+ Hypertension
+11 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Diagnostic Study

Early Phase 1
Interventional
Study Start: October 2025

See protocol details

Summary

Principal SponsorTruway Health, Inc.
Last updated: October 24, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: October 1, 2025Actual 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.

Official TitleEvaluation of Truway Health-Sourced Portable Diagnostic Devices for Early Detection of Chronic Conditions in Outpatient Primary Care Settings: A Prospective Interventional Study 
Principal SponsorTruway Health, Inc.
Last updated: October 24, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
200 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Diagnostic Study
Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants receive treatments one after another in a pre-planned sequence. The next treatment may depend on how the participant responds to the previous one.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Chronic Disease
Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Hypertension
Cardiovascular Disease Acute
Hyperlipidemia
Chronic Kidney Disease (CKD), Stages 3-4 Exercise Tolerance / Functional Capacity Vascular Health / Arterial Stiffness Fatigue in CKD
Peripheral Artery Disease
Metabolic Syndrome
Prediabetes
Criteria
5 inclusion criteria required to participate
ge 18 to 75 years, inclusive
bility to understand the study procedures and provide written informed consent
iagnosis of the target condition according to established clinical or diagnostic criteria
table treatment regimen (pharmacologic or non-pharmacologic) for at least 4 weeks prior to screening

Show More Criteria

6 exclusion criteria prevent from participating
regnancy or breastfeeding at the time of enrollment
nown hypersensitivity to any components of the investigational intervention
ncontrolled or unstable comorbid conditions (for example, cardiovascular, hepatic, renal, or psychiatric disorders)
articipation in another interventional clinical trial within the past 3 months

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Active Comparator
Participants (n=100) will receive standard care without Truway diagnostic devices, following routine primary care practices for chronic condition management. Outcomes will be compared to the intervention group over 6 months, with follow-ups at 3 and 6 months to evaluate standard diagnostic accuracy and clinical results. No additional devices or training are provided.
Group II
Experimental
Participants (n=100) will use Truway Health-sourced portable ultrasound and blood glucose monitors under supervised primary care protocols. The intervention aims to enhance early detection of chronic conditions (e.g., diabetes, cardiovascular disease) over 6 months, with follow-ups at 3 and 6 months to assess diagnostic accuracy and clinical outcomes. Devices are calibrated and provided by Truway Health, Inc., with training for care providers.
Study Objectives
Primary Objectives

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.

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.
Secondary Objectives

The level of participant satisfaction with the use of Truway Health-sourced portable diagnostic devices (ultrasound and blood glucose monitor), measured using a validated satisfaction survey (e.g., Likert scale 1-5) compared to satisfaction with standard care.

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
Suspended
Truway Health, Inc.New York, United StatesSee the location
Enrolling by invitationOne Study Center