Clinical trial

Truway Diagnostic Tools in Primary Care

Invitation only · Early Phase 1 · 1 countries · Registry ID NCT07209527

Invitation onlyEarly Phase 1Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

AgeNot listed to Not listed

SexAll

Healthy volunteersNot accepted

ConditionChronic 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

Full registry 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 \-

Treatments and study arms

Truway Portable Ultrasound Device

Device

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 Monitor

Device

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 Agent

Drug

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.

Primary outcomes

Rate of Early Detection of Chronic Conditions6 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 Control6 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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Truway Health, Inc.🇺🇸 New York, New York, United States

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