Implementation pRogram to Improve Screening and Management for CKD in Diabetes (IRIS-CKD) (Program 2)
Sponsored by Duke University
About this study
IRIS-CKD is a two-program implementation study to improve guideline-recommended screening and treatment of chronic kidney disease (CKD) in individuals with type 2 diabetes (T2D) in the United States.
IRIS-CKD Management Program: will compare prescriptions for guideline-directed medical therapies (GDMT) during the study period. To account for variable GDMT requirements, we will use opportunity scores to compare intervention arms. Patients will be screened, identified and undergo consent by the study site. Patients will receive educational materials related to CKD screening in T2D and details regarding the testing intervention study as per site specific recruitment requirements. The primary objective is to determine whether implementing a guided management program versus education alone will improve prescription of GDMT for people with CKD and T2D. Patients will complete approximately 6 months of follow-up.
Where this study is enrolling (5)
- I'm interested
University of Alabama
Birmingham, Alabama
- I'm interested
University of Michigan
Ann Arbor, Michigan
- I'm interested
Essentia Institute of Rural Health
Duluth, Minnesota
- I'm interested
Duke University
Durham, North Carolina
- I'm interested
Houston Methodist
Houston, Texas
Who can participate
Inclusion criteria
- ✓(CKD Management)
- ✓Adults with type 2 diabetes (T2D)
- ✓Receiving primary care within the healthcare system, visit within 24 months (any PCP provider, including APP)
- ✓Evidence of CKD based on laboratory testing within the past 2 years (must be confirmed during screening if not checked within 3 months of enrollment):
- ✓UACR \>300 mg/g or
- ✓eGFR \<45 ml/min/1.73 m2 or
- ✓UACR ≥30 mg/g with eGFR \<60 ml/min/1.73 m2
- ✓Receiving \<100% GDMT at baseline. For patients with UACR \<30 mg/g, GDMT includes sodium-glucose cotransporter-2 inhibitors (SGLT2i) therapy. For all other eligible patients, GDMT includes ACEi/ARB, SGLT2i, and Finerenone, unless contraindications for any of these therapies exist (e.g., hyperkalemia, diabetic ketoacidosis, etc.).
Exclusion criteria
- ✕(CKD Management)
- ✕Type 1 diabetes
- ✕Most recent eGFR \<20 ml/min/1.73 m2
- ✕Prior kidney transplant
- ✕Autosomal dominant polycystic kidney disease (ADPKD)
- ✕Active pregnancy or plans for conception within 1 year
Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.
Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.
Trial data sourced from ClinicalTrials.gov.