Recruiting

SGLT2 Inhibitor

Sponsor:

University of Minnesota

Code:

NCT07868666

Conditions

Type 2 Diabetes Mellitus

Acute Kidney Injury

Chronic Kidney Diseases

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

Interventions

Clinical Decision Support Message

Study Details

Brief summary:

This pilot study will evaluate the feasibility of using a clinical decision support(CDS) message to support consideration of SGLT2 inhibitor prescribing in patients with type 2 diabetes who recently had acute kidney injury.

Participating M Health Fairview primary care clinics will be randomized to either receive the clinical decision support intervention or continue usual care. In intervention clinics, providers or clinic pharmacists will receive a message before a scheduled encounter with an eligible patient. The message is intended to support clinical decision-making about SGLT2 inhibitor use, but prescribing decisions will remain with the patient's usual clinical care team.

The study will assess feasibility outcomes, including identification of eligible patients, delivery of clinical decision support (CDS) messages, provider/pharmacist receipt of CDS messages, SGLT2i consideration, SGLT2i prescribing, and availability of follow-up kidney function data in the electronic health record.

Conditions

Type 2 Diabetes Mellitus

Acute Kidney Injury

Chronic Kidney Diseases

Study ID

NCT07868666

Start date

Nov 2, 2026

Status verified date

Nov, 2026

Completion date

Oct 31, 2032

Anticipated

Primary completion date

Oct 31, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria for Providers and Pharmacists:

  • Assigned to work in a primary care specialty as a medical provider or assigned to work as a clinic pharmacist
  • Assigned to work in one of the participating study clinics

Inclusion Criteria for Patients:

  • Scheduled to be seen in a participating clinic with a physician or advanced practice provider in a primary care specialty or a clinic pharmacist
  • Medical history of acute kidney injury during a hospitalization with discharge within 1 year before the scheduled appointment
  • Medical history of type 2 diabetes mellitus (by billing code)
  • Age 30 to 75 years at the date of study enrollment
  • Available eGFR from labs more than 3 business days before the scheduled appointment and after AKI onset that is at least 30 mL/min/1.73 m²
  • Either a serum creatinine lab measured after discharge from the hospitalization including the AKI, or the last serum creatinine lab during the hospitalization with AKI is less than 0.3 mg/dL above the patient's baseline serum creatinine concentration

Exclusion Criteria for Providers and Pharmacists:

  • None

Exclusion Criteria for Patients:

  • Opted out of research use of AHC/M Health Fairview data shelter data
  • History of kidney transplantation as a recipient(by billing code)
  • Pregnancy documented in AHC/M Health Fairview data shelter data (by billing code)
  • SGLT2i allergy in the EHR allergy list
  • Medical history of diabetic ketoacidosis, dementia, hospice care, or oncology care (by billing code and/or encounter)
  • Medical history in the prior 1 year of indwelling Foley urinary catheter, cystitis, pyelonephritis, prostatitis, or urinary tract infection (by billing code)
  • Serum creatinine rise of at least 0.3 mg/dL between the two most recent serum creatinine measurements
  • Children
  • Prisoners

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Clinical Decision Support

Primary care clinics randomized to this arm will receive the clinical decision support intervention. For eligible patients, a message will be sent to the scheduled primary care provider or clinic pharmacist before a qualifying encounter. The message provides information to support consideration of SGLT2i prescribing in patients with type 2 diabetes and recent acute kidney injury. Prescribing decisions remain with the patient's usual clinical care team.

no intervention: Usual Care

Primary care clinics randomized to this arm will continue usual care. No study clinical decision support message will be sent. Patients may still receive SGLT2i prescriptions as part of routine clinical care at the discretion of their usual providers.

Interventions

Clinical Decision Support Message

The clinical decision support intervention is a message sent to primary care providers or clinic pharmacists before a scheduled encounter with an eligible patient. The message provides key information to support consideration of SGLT2i prescribing in patients with type 2 diabetes and recent acute kidney injury. The study team will not provide study medication, and prescribing decisions will remain with the usual clinical care team.

Primary outcome measure

  • Feasibility of Identifying Eligible Patients [ Time Frame: From study start through completion of eligible patient identification, up to 4 years ]
  • Feasibility of Clinical Decision Support Message Delivery [ Time Frame: From study start through completion of the CDS intervention period, up to 4 years ]
  • SGLT2i Consideration After Clinical Decision Support [ Time Frame: At the first qualifying primary care encounter ]
  • Follow-up Kidney Function Data Availability [ Time Frame: Within 1 year after the qualifying encounter ]
  • SGLT2i Prescribing After Qualifying Encounter [ Time Frame: Within 4 weeks after the first qualifying primary care appointment and within 1 year after AKI hospitalization discharge ]
  • Feasibility of Adaptive Second Randomization [ Time Frame: During the intervention period, up to 4 years ]

Central Contacts and Locations

Central contacts

Daniel P. Murphy

612-624-9444murph670@umn.edu

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Daniel P Murphy

612-624-9444murph670@umn.edu

More Information

Sponsor

University of Minnesota

Last update posted

Nov 4, 2026

Last verified

Nov, 2026

Keywords

  • SGLT2 inhibitor
  • Acute kidney injury
  • Type 2 diabetes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-05. This information was provided to ClinicalTrials.gov by University of Minnesota on 2026-11-04. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.