Chronic DiseaseEarly Phase 1TruDxPCNCT07209527
Truway Diagnostic Tools in Primary Care
A Early Phase 1 study testing Truway Portable Ultrasound Device, Truway Blood Glucose Monitor and Standard Oral Hypoglycemic Agent in people with Chronic Disease and Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight, run by Truway Health, Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight, Hypertension
- What is being tested?
- Truway Portable Ultrasound Device, Truway Blood Glucose Monitor and Standard Oral Hypoglycemic Agent
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2025to 1 Oct 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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 -
Who cannot join
- 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
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of Truway Health-Sourced Portable Diagnostic Devices for Early Detection of Chronic Conditions in Outpatient Primary Care Settings: A Prospective Interventional Study
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.
Read the detailed description
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 study leverages the company's expertise to address gaps in affordable, point-of-care diagnostics.The study will enroll 200 participants from a single initial site, the Truway Health Clinical Research Center in New York, NY, with plans to expand to a second site in Miami, FL, pending initial results and enrollment success. Participants, aged 18-75 with risk factors for chronic conditions (e.g., obesity, family history), will be randomly assigned to one of two groups: an intervention group using Truway-sourced devices under supervised primary care protocols, or a control group receiving standard care without these tools. The intervention period will span 6 months, with follow-up assessments at 3 and 6 months to evaluate diagnostic accuracy, patient adherence, and clinical outcomes (e.g., HbA1c levels, early detection rates).The primary objective is to determine whether Truway's portable devices enhance early detection rates compared to standard care, with secondary endpoints including cost-effectiveness, patient satisfaction, and healthcare provider feedback. Data will be collected via electronic health records and patient surveys, analyzed using statistical methods to assess significance (p<0.05). The study adheres to FDAAA 801 requirements, with results intended for public posting on ClinicalTrials.gov upon completion.Led by Principal Investigator Gavin Solomon, MD, President \& CEO of Truway Health, Inc., the trial is sponsored by the company with no current U.S. Government funding. Ethical approval from an Institutional Review Board (IRB) is pending, with recruitment targeted to begin February 1, 2026. Challenges include ensuring device calibration across sites and compliance with regulatory reporting timelines. This initiative reflects Truway Health's commitment to innovative healthcare solutions, with findings potentially informing future device distribution and clinical guidelines.
- Conditions
- 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
- Being tested
- Truway Portable Ultrasound Device, Truway Blood Glucose Monitor, Standard Oral Hypoglycemic Agent
- Keywords
- Portable Diagnostic Devices, Ultrasound, Blood Glucose Monitoring, Chronic Disease Management, Early Detection, Primary Care, Interventional Study, Truway Health, Diabetes, Cardiovascular Disease, Hypertension, Obesity, Metabolic Syndrome, Outpatient Care, Clinical Trial
- Medical subject headings
- Chronic Disease, Diabetes Mellitus, Type 2, Obesity, Overweight, Hypertension, Hyperlipidemias, Renal Insufficiency, Chronic, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Truway Portable Ultrasound DeviceDevice
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 MonitorDevice
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 AgentDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group with Truway Diagnostic Devices | 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. Receives: Device: Truway Portable Ultrasound Device; Device: Truway Blood Glucose Monitor; Drug: Standard Oral Hypoglycemic Agent |
| Control Group with Standard Care | 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. Receives: Device: Truway Portable Ultrasound Device; Device: Truway Blood Glucose Monitor; Drug: Standard Oral Hypoglycemic Agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Early Detection of Chronic Conditions
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.
Measured: 6 months
Improvement in Glycemic Control
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.
Measured: 6 months
Secondary outcomes (1)
Patient Satisfaction with Diagnostic Tools
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start1 Oct 2025
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- This study employs an Interventional Study Model designed as a parallel assignment with a sequential enrollment approach. Participants (n=200) will be randomly assigned to one of two groups: an intervention group utilizing Truway Health-sourced portable diagnostic devices (ultrasound and blood glucose monitors) under supervised primary care protocols, or a control group receiving standard care without these tools. The parallel assignment ensures simultaneous comparison of outcomes between the groups over the 6-month intervention period.The sequential enrollment strategy involves staged recruitment, beginning with 100 participants at the initial site (Truway Health Clinical Research Center, New York, NY) starting February 1, 2026, followed by an additional 100 participants at a planned Miami, FL site pending successful interim analysis (targeted for May 2026). This phased approach allows for monitoring of device performance and safety data before expanding, with adjustments to protocols
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Truway Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07209527
- Sponsor's protocol ID
- TRHW-DX-001
- Acronym
- TruDxPC
- Status last verified
- Oct 2025
- First submitted
- 1 Oct 2025
- Last updated
- 24 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Truway Health-Sourced Portable Diagnostic Devices for Early Detection of Chronic Conditions in Outpatient Primary Care Settings: A Prospective Interventional Study
- ClinicalTrials.gov ID
- NCT07209527
- Acronym / sponsor ID
- TruDxPC / TRHW-DX-001
- Conditions
- 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
- Keywords
- Portable Diagnostic Devices, Ultrasound, Blood Glucose Monitoring, Chronic Disease Management, Early Detection, Primary Care, Interventional Study, Truway Health
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Truway Health, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 7 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 study leverages the company's expertise to address gaps in affordable, point-of-care diagnostics.The study will enroll 200 participants from a single initial site, the Truway Health Clinical Research Center in New York, NY, with plans to expand to a second site in Miami, FL, pending initial results and enrollment success. Participants, aged 18-75 with risk factors for chronic conditions (e.g., obesity, family history), will be randomly assigned to one of two groups: an intervention group using Truway-sourced devices under supervised primary care protocols, or a control group receiving standard care without these tools. The intervention period will span 6 months, with follow-up assessments at 3 and 6 months to evaluate diagnostic accuracy, patient adherence, and clinical outcomes (e.g., HbA1c levels, early detection rates).The primary objective is to determine whether Truway's portable devices enhance early detection rates compared to standard care, with secondary endpoints including cost-effectiveness, patient satisfaction, and healthcare provider feedback. Data will be collected via electronic health records and patient surveys, analyzed using statistical methods to assess significance (p<0.05). The study adheres to FDAAA 801 requirements, with results intended for public posting on ClinicalTrials.gov upon completion.Led by Principal Investigator Gavin Solomon, MD, President \& CEO of Truway Health, Inc., the trial is sponsored by the company with no current U.S. Government funding. Ethical approval from an Institutional Review Board (IRB) is pending, with recruitment targeted to begin February 1, 2026. Challenges include ensuring device calibration across sites and compliance with regulatory reporting timelines. This initiative reflects Truway Health's commitment to innovative healthcare solutions, with findings potentially informing future device distribution and clinical guidelines.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study employs an Interventional Study Model designed as a parallel assignment with a sequential enrollment approach. Participants (n=200) will be randomly assigned to one of two groups: an intervention group utilizing Truway Health-sourced portable diagnostic devices (ultrasound and blood glucose monitors) under supervised primary care protocols, or a control group receiving standard care without these tools. The parallel assignment ensures simultaneous comparison of outcomes between the groups over the 6-month intervention period.The sequential enrollment strategy involves staged recruitment, beginning with 100 participants at the initial site (Truway Health Clinical Research Center, New York, NY) starting February 1, 2026, followed by an additional 100 participants at a planned Miami, FL site pending successful interim analysis (targeted for May 2026). This phased approach allows for monitoring of device performance and safety data before expanding, with adjustments to protocols
| Arm | Type | Receives |
|---|---|---|
| Intervention Group with Truway Diagnostic Devices | Experimental | Device: Truway Portable Ultrasound Device, Device: Truway Blood Glucose Monitor, Drug: Standard Oral Hypoglycemic AgentParticipants (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. |
| Control Group with Standard Care | Active comparator | Device: Truway Portable Ultrasound Device, Device: Truway Blood Glucose Monitor, Drug: Standard Oral Hypoglycemic AgentParticipants (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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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 -
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Truway Portable Ultrasound DeviceParticipants 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 | Control Group with Standard Care, Intervention Group with Truway Diagnostic Devices |
| Truway Blood Glucose MonitorParticipants 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. | Device | Control Group with Standard Care, Intervention Group with Truway Diagnostic Devices |
| Standard Oral Hypoglycemic AgentParticipants 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. | Drug | Control Group with Standard Care, Intervention Group with Truway Diagnostic Devices |
Primary outcome
Rate of Early Detection of Chronic Conditions
Time frame: 6 months
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.
Improvement in Glycemic Control
Time frame: 6 months
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.
1 secondary outcome
Patient Satisfaction with Diagnostic Tools
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Truway Portable Ultrasound Device, Truway Blood Glucose Monitor and Standard Oral Hypoglycemic Agent in people with Chronic Disease and Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight, run by Truway Health, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 24 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Early Detection of Chronic Conditions (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2025.