iPATHTechnology-Enabled Care for Adults with Type 2 Diabetes in Federally Qualified Health Centers
iPATH implementation approach
Diabetes Mellitus+3
+ Diabetes Mellitus, Type 2
+ Endocrine System Diseases
Services Research Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.119680 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Services Research Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
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.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalStudy 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
Board of Trustees of the Leland Stanford Junior University
Stanford, United StatesOpen Board of Trustees of the Leland Stanford Junior University in Google MapsPresident and Fellows of Harvard College, T.H. Chan School
Boston, United StatesThe Ohio State University
Columbus, United StatesImpactivo, LLC.
San Juan, Puerto Rico