RecruitingRecruiting
Implementation pRogram to Improve Screening and Management for CKD in Diabetes (Program 1) (IRIS-CKD)
NCT06906627 · Duke University
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Implementation pRogram to Improve Screening and Management for CKD in Diabetes (IRIS-CKD)
About this study
IRIS-CKD Screening Program: will focus on CKD screening in T2D. We will identify patients with T2D that have not received appropriate screening for CKD within the last 15 months and randomize patients to receive either a home kit to complete CKD screening ("home kit") versus a standard laboratory order ("laboratory order"). The primary objective is to evaluate whether delivery of home testing kits versus standard laboratory testing influences the degree to which patients receive guideline-recommended CKD screening. Patients will complete approximately 3 months of follow-up.
Eligibility 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
Study design
Enrollment target: 750 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-10-28
Estimated completion: 2027-04-01
Last updated: 2026-06-16
Interventions
Other: (IRIS-CKD Screening Program): Home KitOther: (IRIS-CKD Screening Program): Standard Lab Order
Primary outcomes
- • CKD Screening Lab Opportunity Score (3 months)
Sponsor
Duke University · other
With: Bayer, Boehringer Ingelheim, Eli Lilly and Company
Contacts & investigators
ContactGretchen Sanders, MSN · contact · gretchen.sanders@duke.edu · 919 6687829
ContactMonica Leyva, MS · contact · monica.leyva@duke.edu
InvestigatorNeha Pagidipati, MD · principal_investigator, Duke University
All locations (7)
University of AlabamaRecruiting
Birmingham, Alabama, United States
Orlando HealthRecruiting
St. Petersburg, Florida, United States
University of MichiganRecruiting
Ann Arbor, Michigan, United States
Essentia HealthRecruiting
Duluth, Minnesota, United States
Duke UniversityRecruiting
Durham, North Carolina, United States
Houston MethodistRecruiting
Houston, North Carolina, United States
Baylor Scott & WhiteRecruiting
Temple, Texas, United States