Recruiting

Observational Study

Sponsor:

Duke University

Code:

NCT06906627

Conditions

Chronic Kidney Disease(CKD)

Type 2 DM

Type 2 Diabetes Mellitus (T2DM)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

(IRIS-CKD Screening Program): Home Kit

(IRIS-CKD Screening Program): Standard Lab Order

Study Details

Brief summary:

IRIS-CKD is an implementation study to improve guideline-recommended screening of chronic kidney disease (CKD) in individuals with type 2 diabetes (T2D) in the United States.

Conditions

Chronic Kidney Disease(CKD)

Type 2 DM

Type 2 Diabetes Mellitus (T2DM)

Study ID

NCT06906627

Start date

Oct 28, 2025

Status verified date

Apr, 2026

Completion date

Apr 1, 2027

Anticipated

Primary completion date

Apr 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

750 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: (IRIS-CKD Screening Program): Home Kit

Home Kit: a kit delivered to participants home with instructions to complete eGFR (fingerstick) and/or UACR (urine sample) testing, depending on which lab(s) are missing at baseline.

active comparator: (IRIS-CKD Screening Program): Standard Lab Testing

Standard Laboratory Testing: a traditional order will be placed into the Electronic Health Record (EHR) for eGFR and/or UACR testing, depending on which lab(s) are missing at baseline.

Interventions

(IRIS-CKD Screening Program): Home Kit

All participants approached for enrollment in Program 1 will receive National Kidney Foundational educational materials related to CKD screening in type 2 diabetes and study information. All enrolled participants will receive a message regarding study lab(s) results.

Home Test Kit: a kit delivered to participants homes with instructions to complete eGFR (fingerstick) and/or UACR (urine sample) testing, depending on which lab(s) are missing at baseline.

(IRIS-CKD Screening Program): Standard Lab Order

ll participants approached for enrollment in Program 1 will receive National Kidney Foundation educational materials related to CKD screening in type 2 diabetes and study information. All enrolled participants will receive a message regarding study lab

Primary outcome measure

  • CKD Screening Lab Opportunity Score [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Gretchen Sanders, MSN

919 6687829gretchen.sanders@duke.edu

Monica Leyva, MS

monica.leyva@duke.edu

Locations

University of Alabama

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Sarah Machado

smachado@uabmc.edu

Principal Investigator:

Clare Lyas, MD

Orlando Health

Recruiting

St. Petersburg, Florida, United States, 33701

Principal Investigator:

Timothy Marsh, DO

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Angie Westover

734-936-6467funke@med.umich.edu

Principal Investigator:

Ilka Decker

Essentia Health

Recruiting

Duluth, Minnesota, United States, 55805

Contacts

Haley Messenger

haley.messenger@essentiahealth.org

Principal Investigator:

Sreedhar Devathi, MD

Duke University

Recruiting

Durham, North Carolina, United States, 27707

Contacts

Kim Cicio

kimberly.cicio@duke.edu

Principal Investigator:

John Middleton, MD

Houston Methodist

Recruiting

Houston, North Carolina, United States, 77030

Contacts

Steven Puckett

srpuckitt@houstonmethodist.org

Principal Investigator:

Peter Nguyen

Baylor Scott & White

Recruiting

Temple, Texas, United States, 76508

Principal Investigator:

Tariq Shafi, MD

More Information

Sponsor

Duke University

Last update posted

Jun 16, 2026

Last verified

Apr, 2026

Keywords

  • CKD
  • T2DM
  • T2D
  • Type 2 Diabetes
  • Chronic kidney disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-06-16.