Scaling team‑based, technology‑enabled care to improve diabetes control for adults with type 2 diabetes
Implementing Scalable, PAtient-centered, Team-based, Technology-enabled Care for Adults With Type 2 Diabetes (iPATH)
This project will try a team-based, tech-enabled care program called iPATH to improve blood sugar control for adults with type 2 diabetes treated at federally qualified health centers.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 119680 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Stanford University Academic / other |
| Locations | 4 sites (Stanford, California and 3 other locations) |
| Trial ID | NCT06251323 on ClinicalTrials.gov |
What this trial studies
Sixteen federally qualified health center (FQHC) clinic sites will be selected from HRSA data and followed for up to three years to measure changes in patient HbA1c. Eight clinics will begin the iPATH practice transformation in year one and the other eight will begin in year two, creating a staggered implementation for comparison. Clinic administrators, clinicians, and staff will participate in the transformation and take part in qualitative interviews and 12 in-depth regional case studies to identify organizational factors that help or hinder diabetes care. Patient HbA1c data will be collected annually to compare changes before and after implementation and between early and later adopters.
Who should consider this trial
Good fit: Adults with type 2 diabetes who receive primary care at participating FQHC clinics—especially those served by clinics with below-average A1c control—are the intended participants.
Not a fit: Children, patients at clinics with very low diabetes prevalence, and people receiving care outside the selected FQHCs or regions are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, iPATH could reduce average HbA1c and the proportion of patients with poorly controlled diabetes at participating FQHCs, improving long-term health outcomes for underserved populations.
How similar studies have performed: A prior pilot of the iPATH approach at seven clinics in Puerto Rico reported an average 31% reduction in the number of patients with A1c >9%, showing promising earlier results.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Stanford, California and 3 other locations
- Board of Trustees of the Leland Stanford Junior University — Stanford, California, United States (Recruiting)
- President and Fellows of Harvard College, T.H. Chan School — Boston, Massachusetts, United States (Recruiting)
- The Ohio State University — Columbus, Ohio, United States (Recruiting)
- Impactivo, LLC. — San Juan, Puerto Rico, Puerto Rico (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.