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Implementation pRogram to Improve Screening and Management for CKD in Diabetes (IRIS-CKD) (Program 2)

Implementation pRogram to Improve Screening and Management for CKD in Diabetes (IRIS-CKD) (Program 2)

Recruiting
18 years and older
All
Phase N/A

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Overview

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.

Description

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.

Eligibility

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

Study details
    Chronic Kidney Disease(CKD)
    Type 2 DM
    Type 2 Diabetes Mellitus (T2DM)

NCT06906640

Duke University

1 February 2026

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