Recruiting

iPATHTechnology-Enabled Care for Adults with Type 2 Diabetes in Federally Qualified Health Centers

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What is being tested

iPATH implementation approach

Other
Who is being recruted

Diabetes Mellitus+3

+ Diabetes Mellitus, Type 2

+ Endocrine System Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Services Research Study

Interventional
Study Start: September 2025
See protocol details

Summary

Principal SponsorStanford University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 30, 2025

Actual date on which the first participant was enrolled.

This study focuses on improving care for adults with type 2 diabetes, especially among racial and socioeconomic minorities in the U.S. Health centers known as Federally Qualified Health Centers (FQHCs) serve many people from these groups and have a higher occurrence of diabetes. The goal is to refine a care approach called iPATH, which has previously helped reduce poorly controlled diabetes. By enhancing this method, the project aims to ensure better diabetes management in these communities, addressing health disparities and improving patient safety and care quality. The study involves implementing a structured care strategy in eight FQHCs across the U.S., including locations in California, Massachusetts, Ohio, and Puerto Rico. Researchers will conduct detailed studies to understand what makes diabetes care effective in these centers. They will use rapid data collection to provide quick feedback and tailor strategies to fit the specific needs of each center. The outcomes will be evaluated using a special trial method to assess the effectiveness of the iPATH approach in managing diabetes and reducing health disparities. The study will help identify the best practices for implementing diabetes care improvements in diverse healthcare settings.

Official TitleImplementing Scalable, PAtient-centered, Team-based, Technology-enabled Care for Adults With Type 2 Diabetes (iPATH)
NCT06251323
Principal SponsorStanford University
Last updated: January 28, 2026
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

119680 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Services Research Study

These studies look at how healthcare is delivered, managed, and organized. They aim to improve care quality, patient experience, and access to treatment.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Criteria

Inclusion Criteria: * Two largest clinic sites in multi-clinic FQHCs operating in or near Massachusetts, Ohio, California, Puerto Rico * We will prioritize FQHCs performing in the lower half of the distribution for A1c control, as these FQHCs have greater room for improvement. Exclusion Criteria: * FQHCs that have a patient population comprised of more than 80% children * FQHCs that have a patient population multiplied by the FQHC's diabetes prevalence in the lowest 10% of all the clinics * FQHCs that have fewer than 5,000 or more than 50,000 patients.

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

Experimental
Clinics will have data evaluated for up to 3 years. Wave 1 clinics will begin the iPATH practice transformation in Year 1.

Group II

Experimental
Clinics will have data evaluated for up to 3 years. Wave 2 clinics will begin the iPATH practice transformation in Year 2.

Study Objectives

Primary 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 4 locations

Recruiting

Board of Trustees of the Leland Stanford Junior University

Stanford, United StatesOpen Board of Trustees of the Leland Stanford Junior University in Google Maps
Recruiting

President and Fellows of Harvard College, T.H. Chan School

Boston, United States
Recruiting

The Ohio State University

Columbus, United States
Recruiting

Impactivo, LLC.

San Juan, Puerto Rico
Recruiting
4 Study Centers
iPATH | Technology-Enabled Care for Adults with Type 2 Diabetes in Federally Qualified Health Centers | PatLynk