Type 2 Diabetes MellitusNCT07868666
Clinical Decision Support for SGLT2i After AKI in Type 2 Diabetes
A study testing Clinical Decision Support Message in people with Type 2 Diabetes Mellitus and Acute Kidney Injury, run by University of Minnesota.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Acute Kidney Injury, Chronic Kidney Diseases
- What is being tested?
- Clinical Decision Support Message
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- 20 Oct 2026to 31 Oct 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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
Who cannot join
- None
- 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)
Show all 10Show fewer
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Decision Support for SGLT2i After AKI in Type 2 Diabetes Pilot Study
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.
Read the detailed description
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.
- Conditions
- Type 2 Diabetes Mellitus, Acute Kidney Injury, Chronic Kidney Diseases, SGLT2 Inhibitor Use
- Being tested
- Clinical Decision Support Message
- Keywords
- SGLT2 inhibitor, Acute kidney injury, Type 2 diabetes, SGLT2i
- Medical subject headings
- Diabetes Mellitus, Type 2, Acute Kidney Injury, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Decision Support MessageOther
Also called CDS 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.
| Study group | Role | What they receive |
|---|---|---|
| Clinical Decision Support | Experimental | 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. Receives: Other: Clinical Decision Support Message |
| Usual Care | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: During the intervention period, up to 4 years
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Within 1 year after study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start20 Oct 2026 (estimated)
- Primary completion31 Oct 2032 (estimated)
- Study completion31 Oct 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a pilot adaptive cluster randomized clinical trial. Participating M Health Fairview primary care clinics will be randomized 1:1 to receive a clinical decision support intervention or continue usual care. The intervention consists of a clinical decision support(CDS) message sent to primary care providers or clinic pharmacists before scheduled encounters with eligible patients. Patients in the intervention arm who attend a qualifying encounter but have no evidence of SGLT2i consideration may undergo a second adaptive randomization to either no further CDS messages or additional CDS messages before a future qualifying encounter.
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Murphy, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07868666
- Sponsor's protocol ID
- NEPH-2026-34567
- Other IDs
- 1K23DK144716-01
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Decision Support for SGLT2i After AKI in Type 2 Diabetes Pilot Study
- ClinicalTrials.gov ID
- NCT07868666
- Acronym / sponsor ID
- NEPH-2026-34567
- Conditions
- Type 2 Diabetes Mellitus, Acute Kidney Injury, Chronic Kidney Diseases, SGLT2 Inhibitor Use
- Keywords
- SGLT2 inhibitor, Acute kidney injury, Type 2 diabetes, SGLT2i
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 20 Oct 2026 (estimated)
- Primary completion
- 31 Oct 2032 (estimated)
- Study completion
- 31 Oct 2032 (estimated)
- First posted
- 9 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a pilot adaptive cluster randomized clinical trial. Participating M Health Fairview primary care clinics will be randomized 1:1 to receive a clinical decision support intervention or continue usual care. The intervention consists of a clinical decision support(CDS) message sent to primary care providers or clinic pharmacists before scheduled encounters with eligible patients. Patients in the intervention arm who attend a qualifying encounter but have no evidence of SGLT2i consideration may undergo a second adaptive randomization to either no further CDS messages or additional CDS messages before a future qualifying encounter.
| Arm | Type | Receives |
|---|---|---|
| Clinical Decision Support | Experimental | Other: Clinical Decision Support MessagePrimary 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. |
| Usual Care | No intervention | –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. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
- 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)
Key exclusion criteria (10 listed)
- None
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical Decision Support MessageAlso: CDS MessageThe 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. | Other | Clinical Decision Support |
Primary outcome
Feasibility of Identifying Eligible Patients
Time frame: From study start through completion of eligible patient identification, up to 4 years
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.
Feasibility of Clinical Decision Support Message Delivery
Time frame: From study start through completion of the CDS intervention period, up to 4 years
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.
SGLT2i Consideration After Clinical Decision Support
Time frame: At the first qualifying primary care encounter
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.
Follow-up Kidney Function Data Availability
Time frame: Within 1 year after the qualifying encounter
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.
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
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.
Feasibility of Adaptive Second Randomization
Time frame: During the intervention period, up to 4 years
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.
5 secondary outcomes
Forty Percent eGFR Reduction
Time frame: Within 1 year after AKI onset
Urine Albumin-to-Creatinine Ratio Follow-up and Relative Reduction
Time frame: Within 1 year after study enrollment
Hospitalization
Time frame: Within 1 year after study enrollment
Recurrent Acute Kidney Injury
Time frame: Within 1 year after study enrollment
Mortality
Time frame: Within 1 year after study enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniel Murphy principal investigator
University of Minnesota
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Decision Support Message in people with Type 2 Diabetes Mellitus and Acute Kidney Injury, run by University of Minnesota.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel P. Murphy (612-624-9444, murph670@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Identifying Eligible Patients (time frame: From study start through completion of eligible patient identification, up to 4 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.