An interventional study of Clinical Decision Support Message in Type 2 Diabetes Mellitus, Acute Kidney Injury and Chronic Kidney Diseases, sponsored by University of Minnesota. Not yet recruiting. Open to participants aged 30 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by University of Minnesota · Not applicable, Interventional, and Health services research
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.
Sodium-glucose co-transporter-2 inhibitors are FDA-approved medications for type 2 diabetes and have been shown to reduce kidney and cardiovascular risks in several patient populations. However, providers may be hesitant to prescribe SGLT2 inhibitors to patients who have recently experienced acute kidney injury because of concerns about kidney function changes after initiation.
This study is a pilot adaptive cluster randomized clinical trial conducted in participating M Health Fairview primary care clinics. Clinics will be randomized 1:1 to receive a clinical decision support intervention or continue usual care. The intervention consists of a message sent to the primary care provider or clinic pharmacist before a scheduled encounter with an eligible patient.
Eligible patients will be adults aged 30 to 75 years with type 2 diabetes, a history of acute kidney injury during a hospitalization with discharge within the prior year, and kidney function meeting study criteria. The study team will not provide SGLT2 inhibitors or direct treatment. All prescribing decisions, including whether to prescribe an SGLT2 inhibitor and which medication to use, will remain with the patient's usual provider and clinical care team.
The adaptive component applies only within the intervention arm. Patients in intervention clinics who attend a qualifying encounter but have no evidence of SGLT2i consideration may be randomized before a later qualifying encounter to receive either no further CDS messages or additional CDS messages.
The primary focus of this pilot study is feasibility. Outcomes will be collected from the electronic health record and the AHC/M Health Fairview data shelter. Feasibility outcomes include the number of eligible patients identified, CDS messages sent, providers or pharmacists receiving messages, patients with SGLT2i mentioned or prescribed, patients with follow-up kidney function data, and patients undergoing the second adaptive randomization step.
9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.
This study's planned enrollment of 250 is above the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →University of Minnesota is the lead sponsor of 1,210 studies on the registry; 195 are open to participants now.
Of its 133 completed or terminated interventional studies of FDA-regulated products, 92 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria for Providers and Pharmacists:
Inclusion Criteria for Patients:
Exclusion Criteria for Providers and Pharmacists:
Exclusion Criteria for Patients:
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.
Other: Clinical Decision Support Message
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.
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.
Also known as: CDS Message
Feasibility of Identifying Eligible Patients
Feasibility will be assessed by the number of patients meeting study inclusion and exclusion criteria who are identified as having a qualifying scheduled primary care or clinic pharmacist appointment in participating clinics.
Time frame: From study start through completion of eligible patient identification, up to 4 years
Feasibility of Clinical Decision Support Message Delivery
Feasibility of CDS delivery will be assessed by the number of CDS messages sent for first qualifying appointments, the number of intervention messages sent for all qualifying appointments, and the number of unique providers or pharmacists receiving CDS messages.
Time frame: From study start through completion of the CDS intervention period, up to 4 years
SGLT2i Consideration After Clinical Decision Support
SGLT2i consideration will be assessed by the number of patients with any mention of SGLT2i in encounter notes or related clinical documentation for the first qualifying primary care encounter.
Time frame: At the first qualifying primary care encounter
Follow-up Kidney Function Data Availability
Feasibility of outcome data capture will be assessed by the number of patients with follow-up serum creatinine values available in the electronic health record for follow-up eGFR calculation after the intervention.
Time frame: Within 1 year after the qualifying encounter
SGLT2i Prescribing After Qualifying Encounter
SGLT2i prescribing will be assessed by the number of patients with an SGLT2i prescribed within 4 weeks after the first qualifying primary care appointment and within 1 year after the AKI hospitalization discharge date.
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
Feasibility of the adaptive design will be assessed by the number of patients undergoing the second randomization step and the number of patients with an SGLT2i prescribed within 4 weeks after the second randomization.
Time frame: During the intervention period, up to 4 years
Forty Percent eGFR Reduction
The number of patients with a 40% reduction in eGFR at the final available eGFR within 1 year of AKI onset will be assessed, including time to event from AKI onset.
Time frame: Within 1 year after AKI onset
Urine Albumin-to-Creatinine Ratio Follow-up and Relative Reduction
The number of patients with follow-up urine albumin-to-creatinine ratio measured will be assessed. Among patients with a known pre-AKI value, relative reduction in urine albumin-to-creatinine ratio will be calculated using available electronic health record laboratory data.
Time frame: Within 1 year after study enrollment
Hospitalization
Hospitalization will be assessed using electronic health record data as the number of patients with an event and time to event.
Time frame: Within 1 year after study enrollment
Recurrent Acute Kidney Injury
Recurrent acute kidney injury will be assessed using electronic health record data as the number of patients with an event and time to event.
Time frame: Within 1 year after study enrollment
Mortality
Mortality will be assessed using electronic health record data as the number of patients with an event and time to event.
Time frame: Within 1 year after study enrollment
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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