Team-Based Care for Type 2 Diabetes

(iPATH Trial)

Recruiting at 3 trial locations

Overseen By Suzanne Tamang, PHD, MPhil, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Children, Low diabetes prevalence, others

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

Compensation: Varies

Number of Visits: Unknown

119680 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach called iPATH, a team-based care strategy, to improve care for people with Type 2 Diabetes at certain health clinics. The goal is to determine if this approach can help clinics manage diabetes better by analyzing blood sugar data (HbA1c) over several years. The study includes clinics in or near Massachusetts, Ohio, California, and Puerto Rico that need improvement in diabetes control. Clinics with a large number of children or very small or large patient populations are excluded. As an unphased trial, this study offers a unique opportunity to contribute to innovative diabetes care strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that the iPATH implementation approach is safe for team-based care in clinics?

Research has shown that the iPATH approach aims to improve care for people with type 2 diabetes. While specific safety data for iPATH is not available, the project emphasizes changing how clinics collaborate to assist patients. It focuses on enhancing teamwork in care rather than testing a new drug or treatment.

A small study found that iPATH led to a 31% reduction in cases of poorly controlled diabetes, suggesting the program is effective and likely safe. Since iPATH involves modifying clinic operations instead of introducing a new drug, it presents fewer risks of side effects commonly associated with new medications.

Overall, iPATH appears safe because it enhances existing care rather than adding new medical treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the iPATH implementation approach for managing Type 2 Diabetes because it focuses on transforming clinic practices to improve patient outcomes. Unlike traditional treatments that primarily rely on medications like metformin or insulin, iPATH emphasizes a team-based care model. This approach aims to enhance communication and coordination among healthcare providers, leading to more personalized and efficient care for patients. By restructuring how clinics operate, iPATH has the potential to make diabetes management more proactive and patient-centered, which could significantly improve long-term health outcomes.

What evidence suggests that the iPATH implementation approach is effective for managing Type 2 Diabetes?

Research has shown that the iPATH approach can greatly improve diabetes care. In a small study, cases of poorly controlled diabetes (where A1c levels exceed 9%) decreased by 31% among patients at clinics using this method. In this trial, the iPATH approach will be implemented in two separate groups: Wave 1 Clinics will begin the iPATH practice transformation in Year 1, and Wave 2 Clinics will start in Year 2. iPATH focuses on team-based care, where healthcare professionals collaborate to manage type 2 diabetes. This strategy is being refined to understand what makes it effective or not in community health centers. Overall, early results suggest iPATH could be a promising way to improve diabetes care. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

The iPATH trial is for the two largest clinic sites within multi-clinic FQHCs located in or near Massachusetts, Ohio, California, and Puerto Rico. These clinics should be performing in the mid-range for diabetes control (3rd quartile) with adult patients having poorly controlled diabetes.

Inclusion Criteria

Organizations included will be the two largest clinic sites in multi-clinic FQHCs operating in or near Massachusetts, Ohio, California, Puerto Rico, performing in the 3rd quartile for percentage of patients with poorly controlled diabetes (A1c>9%)

Exclusion Criteria

Exclude FQHCs that have a patient population comprised of more than 80% children

Exclude FQHCs that have a patient population multiplied by the FQHC's diabetes prevalence in the lowest 10% of all the clinics

Exclude FQHCs that have fewer than 5,000 or more than 50,000 patients

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Implementation of the iPATH practice transformation strategy at FQHCs

1 year

Ongoing visits as part of practice transformation

Evaluation

Comprehensive evaluation of the iPATH implementation approach using a hybrid type 2 study

1 year

Follow-up

Participants are monitored for safety and effectiveness after practice transformation

1 year

What Are the Treatments Tested in This Trial?

Interventions

• iPATH implementation approach

Trial Overview iPATH aims to improve type 2 diabetes care by refining a practice transformation approach at FQHCs. It involves identifying effective organizational processes pre- and post-pandemic, implementing technology-enabled strategies tailored to each clinic's needs, and evaluating these changes using a hybrid study design.

How Is the Trial Designed?

Group I: Wave 2 Clinics Experimental Treatment 1 Intervention

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

Group II: Wave 1 Clinics Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Impactivo, LLC.

Collaborator

Trials

1

Recruited

120,000+

Ohio State University

Collaborator

Trials

891

Recruited

2,659,000+

Harvard School of Public Health (HSPH)

Collaborator

Trials

283

Recruited

17,030,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Published Research Related to This Trial

Insulin pump therapy (CSII) is crucial for managing type 1 diabetes, but it carries risks of serious complications like hyperglycemia and hypoglycemia due to various factors including pump failures and user errors.

There is a lack of transparency and sufficient data on the safety and long-term efficacy of insulin pumps, highlighting the need for better regulatory practices and more public funding for research to improve user education and prevent adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insulin pump risks and benefits: a clinical appraisal of pump safety standards, adverse event reporting, and research needs: a joint statement of the European Association for the Study of Diabetes and the American Diabetes Association Diabetes Technology Working Group. Heinemann, L., Fleming, GA., Petrie, JR., et al.[2022]

The study reviewed 15 articles out of 6435 identified, focusing on the effectiveness of the IHI Outpatient Adverse Event Trigger Tool in detecting preventable adverse events (pAEs) in primary care, with medication errors being the most common pAE identified.

Results showed that the effectiveness of the IHI Tool in identifying adverse events varied significantly, indicating a need for improved detection methods and further research to enhance patient safety in outpatient settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Accuracy of Trigger Tools to Detect Preventable Adverse Events in Primary Care: A Systematic Review. Davis, J., Harrington, N., Bittner Fagan, H., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06251323?term=hrsa&viewType=Table&rank=5

Implementing Scalable, PAtient-centered, Team-based, ... A pilot demonstrated significant decreases (average 31% reduction) in poorly controlled diabetes (A1c>9%) among patients at 7 clinics affiliated with an FQHC in ...

2. rethinkingclinicaltrials.org rethinkingclinicaltrials.org/news/september-25-2025-ipath-researchers-identify-factors-linked-to-cardiovascular-care-performance-in-community-health-centers/

September 25, 2025: iPATH Researchers Identify Factors ... The study will evaluate the impact of the practice transformation strategy and identify process elements that influence implementation ...

3. reporter.nih.gov reporter.nih.gov/search/-DpTO_pygUmulY7-h1pyHA/project-details/10892158

Project Details Refine the iPATH implementation approach by identifying organizational conditions and processes at FQHCs that promoted or impeded the effectiveness of type 2 ...

4. withpower.com withpower.com/trial/phase-diabetes-mellitus-type-2-6-2025-f259e

Team-Based Care for Type 2 Diabetes (iPATH Trial) The iPATH implementation approach is unique because it focuses on team-based care, involving a coordinated effort by healthcare professionals to manage type 2 ...

5. rethinkingclinicaltrials.org rethinkingclinicaltrials.org/news/august-26-2024-ipath-trial-aims-to-improve-diabetes-care-in-community-health-centers/

August 26, 2024: iPATH Trial Aims to Improve Diabetes ... iPATH aims to identify, rigorously test, and disseminate promising care delivery innovations in FQHCs across 4 US regions (Northeast, Midwest, ...

6. rethinkingclinicaltrials.org rethinkingclinicaltrials.org/demonstration-projects/ipath/

Implementing Scalable, PAtient-centered Team-based ... The iPATH project will refine and implement an approach to practice transformation originally conceived to support FQHCs' pursuit of National Committee for ...

7. dcricollab.dcri.duke.edu dcricollab.dcri.duke.edu/sites/NIHKR/KR/iPATH%20Study%20Snapshot.pdf

Implementing Scalable, Patient-Centered, Team A pilot study demonstrated significant decreases (average 31% reduction) in poorly controlled diabetes among patients at 7 clinics affiliated ...