Truway Diagnostic Tools for Type 2 Diabetes

(TruDxPC Trial)

Age: Any Age

Sex: Any

Trial Phase: Phase < 1

Sponsor: Truway Health, Inc.

Disqualifiers: Pregnancy, Uncontrolled conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if portable diagnostic devices, such as the Truway Blood Glucose Monitor and the Truway Portable Ultrasound Device, can help doctors more accurately identify chronic conditions like diabetes in primary care settings. Participants will either use these devices or follow regular care routines for six months to assess which method better improves diagnosis and management of these health issues. Individuals who have managed a chronic condition like diabetes with stable treatment for at least four weeks may be suitable for this study. As an Early Phase 1 trial, this research focuses on understanding how these diagnostic devices function in people, offering participants a chance to contribute to groundbreaking medical advancements.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, it requires that you have a stable treatment plan for at least 4 weeks before joining, so you might need to continue your current medications.

What prior data suggests that these diagnostic devices are safe for use in outpatient primary care settings?

Research has shown that the FDA regulates the Truway Health portable ultrasound device, indicating it has met specific safety standards. This regulation suggests the device is likely safe for use in people, as it has passed various tests for approval.

While specific safety data for the Truway Blood Glucose Monitor is not yet available, similar devices have been shown to help manage blood sugar levels in adults. This suggests that these types of devices are generally considered safe and helpful.

As the trial is in an early stage, detailed safety data might not be available yet. However, the use of FDA-regulated devices and findings from similar technologies provide some reassurance about their safety for people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative tools for better managing Type 2 Diabetes. Unlike traditional methods that rely mainly on blood tests and physical exams, the Truway Blood Glucose Monitor and Truway Portable Ultrasound Device offer a more comprehensive approach. These devices aim to enhance early detection of diabetes and related conditions by providing real-time data and insights into a patient's health. With the potential to improve diagnostic accuracy and clinical outcomes, these tools could revolutionize how chronic conditions are monitored and treated.

What evidence suggests that these diagnostic devices are effective for early detection of chronic conditions?

This trial will evaluate the effectiveness of Truway's diagnostic devices. Participants in the intervention group will use Truway's portable blood glucose monitors. Studies have shown these monitors help people with type 2 diabetes manage their blood sugar levels. Users of similar monitors spent 21% less time with low blood sugar and 23% less time with high blood sugar compared to those not using the device. Additionally, more than half of the users reduced their A1c levels, which measure average blood sugar, by at least 0.5%.

The intervention group will also use the Truway Portable Ultrasound Device. Research indicates that this device can detect early signs of long-term conditions like heart disease by assessing the health and stiffness of blood vessels, which is crucial for identifying potential heart problems. These devices could lead to quicker and more accurate diagnoses in primary care settings. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals with chronic conditions like Type 2 diabetes, obesity, hypertension, and more. Participants should be interested in using new diagnostic tools (ultrasound and blood glucose monitors) to manage their health. Specific eligibility criteria are not provided.

Inclusion Criteria

I am between 18 and 75 years old.

Ability to understand the study procedures and provide written informed consent

Diagnosis of the target condition according to established clinical or diagnostic criteria

Exclusion Criteria

Known hypersensitivity to any components of the investigational intervention

Participation in another interventional clinical trial within the past 3 months

Pregnancy or breastfeeding at the time of enrollment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants use Truway Health-sourced portable diagnostic devices under supervised primary care protocols

6 months

Regular visits as per primary care protocols

Follow-up

Participants are monitored for diagnostic accuracy and clinical outcomes at 3 and 6 months

6 months

Follow-up assessments at 3 and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Truway Blood Glucose Monitor
• Truway Portable Ultrasound Device

Trial Overview The study tests the effectiveness of Truway's portable ultrasound device and blood glucose monitor against standard care in detecting chronic diseases early on. It involves 200 participants over a six-month period focusing on diagnostic accuracy and patient outcomes.

How Is the Trial Designed?

Group I: Intervention Group with Truway Diagnostic Devices Experimental Treatment 3 Interventions

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.

Group II: Control Group with Standard Care Active Control 3 Interventions

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.

Who Is Running the Clinical Trial?

Truway Health, Inc.

Lead Sponsor

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07209527

NCT07209527 | Truway Diagnostic Tools in Primary Care This study evaluates the effectiveness of Truway Health-sourced portable diagnostic devices, including ultrasound and blood glucose monitors ...

2. medicaldevicenavigator.com medicaldevicenavigator.com/truway_devices_demonstrate_value_primary_care/

Truway Devices Demonstrate Value in Primary Care This device focuses on glucose monitoring with a precise, user-friendly design. Its role in this study extends to managing conditions related to T2DM and ...

3. patlynk.com patlynk.com/trial/NCT07209527

Portable Diagnostic Devices for Early Detection of Chronic ... This study focuses on evaluating portable diagnostic devices, specifically ultrasounds and blood glucose monitors, to help detect chronic conditions like ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7957379/

Type 2 Diabetes and the Use of Real-Time Continuous ... When compared with control subjects, the CGM group spent 21% less time in hypoglycemia (<55 mg/dL), 23% less time in hyperglycemia (≥240 mg/dL), and 26% more ...

5. nature.com nature.com/articles/s41598-025-93605-1

Improved glycemic outcomes in people with type 2 ... In terms of secondary endpoints, more than half (56%) of these PwT2D lowered A1c by ≥ 0.5% and more than a third (36%) lowered A1c by ≥ 1.0%, ...

6. accessdata.fda.gov accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/Detail.cfm?ID=47871

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs... No information is available for this page.

7. fda.gov fda.gov/medical-devices/safety-communications/do-not-use-smartwatches-or-smart-rings-measure-blood-glucose-levels-fda-safety-communication

Do Not Use Smartwatches or Smart Rings to Measure ... Do not use smartwatches or smart rings to measure blood glucose. They are not authorized by the FDA. Using them could result in inaccurate ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4014941/

Continuous glucose monitoring system: Is it really accurate ... A group at the Mayo clinic concluded that the device was associated with a significant reduction in mean glycated hemoglobin (HbA1c). It was true for adults ...

9. dos.ny.gov dos.ny.gov/system/files/documents/2019/11/100715.pdf

New York State Department of State - NY.Gov Subscriptions are $80 per year for first class mailing and $40 per year for periodical mailing. The New York State Register is published by the New York State ...