Improving kidney disease screening for adults with type 2 diabetes
Implementation pRogram to Improve Screening and Management for CKD in Diabetes (IRIS-CKD)
This program will test whether mailing home urine/blood test kits or giving a standard lab order helps adults with type 2 diabetes complete recommended kidney screening.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 750 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Locations | 6 sites (Birmingham, Alabama and 5 other locations) |
| Trial ID | NCT06906627 on ClinicalTrials.gov |
What this trial studies
IRIS-CKD identifies adults with type 2 diabetes who have not had guideline-recommended kidney testing (eGFR and/or urine albumin-creatinine ratio) in the prior 15 months and randomizes them to receive either a mailed home testing kit or a standard laboratory order. The trial compares completion rates of CKD screening between the two arms over about three months of follow-up. Participants are drawn from primary care populations within participating US health systems and those with an existing CKD diagnosis are excluded. The primary outcome is whether home kits increase the proportion of patients who complete recommended screening compared with standard lab orders.
Who should consider this trial
Good fit: Adults with type 2 diabetes who receive primary care within a participating health system and who lack an eGFR and/or UACR measurement in the past 15 months and do not have a CKD diagnosis are eligible.
Not a fit: Patients who already have a documented CKD diagnosis or who recently completed the recommended kidney tests are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, more people with type 2 diabetes could complete kidney screening earlier, enabling earlier detection and management of CKD.
How similar studies have performed: Similar outreach and home-testing approaches have increased screening uptake in other settings and small pilot CKD programs, but large randomized evidence across diverse US primary-care populations is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Screening Program- Inclusion Criteria: * Adults with type 2 diabetes (T2D) * Receiving primary care within the healthcare system, Primary Care Provider (PCP) visit within the past 24 months (any PCP provider, including APP). * Lack of estimated glomerular filtration rate (eGFR) and/or urine albumin- creatinine ratio (UACR) measurement in the prior 15 months within the EHR Exclusion Criteria: • Chronic kidney disease (CKD) diagnosis
Where this trial is running
Birmingham, Alabama and 5 other locations
- University of Alabama — Birmingham, Alabama, United States (Recruiting)
- Orlando Health — St. Petersburg, Florida, United States (Recruiting)
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
- Essentia Health — Duluth, Minnesota, United States (Recruiting)
- Duke University — Durham, North Carolina, United States (Recruiting)
- Baylor Scott & White — Temple, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Neha Pagidipati, MD — Duke University
- Study coordinator: Gretchen Sanders, MSN
- Email: gretchen.sanders@duke.edu
- Phone: 919 6687829
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.