Implementation pRogram to Improve Screening and Management for CKD in Diabetes (Program 1) (IRIS-CKD)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Duke University
Study ID
NCT06906627
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • (IRIS-CKD Screening Program): Home Kit — OTHER
    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 — OTHER
    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

Study Details

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.

Key Dates

Start date
Oct 28, 2025
Status verified
Apr 2026
Primary completion
Apr 1, 2027
Completion
Apr 1, 2027

Study Design

Enrollment
750 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

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.

Primary Outcome Measure

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

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
University of AlabamaBirminghamAlabama35233
Sarah Machado
[email protected]
Clare Lyas, MD (PRINCIPAL_INVESTIGATOR)
Orlando HealthSt. PetersburgFlorida33701
Timothy Marsh, DO (PRINCIPAL_INVESTIGATOR)
University of MichiganAnn ArborMichigan48109
Angie Westover
[email protected]
734-936-6467
Ilka Decker (PRINCIPAL_INVESTIGATOR)
Essentia HealthDuluthMinnesota55805
Haley Messenger
[email protected]
Sreedhar Devathi, MD (PRINCIPAL_INVESTIGATOR)
Duke UniversityDurhamNorth Carolina27707
John Middleton, MD (PRINCIPAL_INVESTIGATOR)
Baylor Scott & WhiteTempleTexas76508
Tariq Shafi, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Birmingham, AL

By research site
University of Alabama· Birmingham, ALOrlando Health· St. Petersburg, FLUniversity of Michigan· Ann Arbor, MIEssentia Health· Duluth, MNDuke University· Durham, NCBaylor Scott & White· Temple, TX

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