RecruitingNot ApplicableNCT06906640

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 (Program 2) (IRIS-CKD)

Sponsor

Duke University

Enrollment

420 participants

Start Date

Oct 28, 2025

Study Type

INTERVENTIONAL

Conditions

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

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria8

(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 Criteria6

(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

Interventions

OTHER(IRIS-CKD Management Program): Education

Patients randomized to the education arm will receive targeted education materials regarding their severity of CKD, including the potential for additional GDMT to slow CKD progression to discuss with their Primary Care Provider (PCP). At 6 months, the study pharmacist (or APP) will order repeat eGFR and UACR after 6 months to standardize CKD follow up during the study period.

OTHER(IRIS-CKD Management Program): GDMT

Patients randomized to the education arm will receive targeted education materials regarding their severity of CKD, including the potential for additional GDMT to slow CKD progression to discuss with their PCP. At 6 months, the study pharmacist (or APP) will order repeat eGFR and UACR after 6 months to standardize CKD follow up during the study period. Plus, receive guided care by APP.