New study aims to prevent dangerous ketosis in type 1 diabetes patients with kidney disease
NCT ID NCT07325201
First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 4 times
Summary
This study looks at how to safely use a type of diabetes drug (SGLT1&2 inhibitor) in people with type 1 diabetes and mild to moderate chronic kidney disease. The goal is to find out what increases the risk of a serious condition called diabetic ketoacidosis (DKA). About 80 adults will wear continuous glucose and ketone monitors and take the study drug for nine months. The results will help create better reports to warn patients and doctors about ketosis risk.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Provision of signed and dated informed consent form. 2. Stated willingness to comply with all study procedures and availability for the duration of the study. 3. Males and females; Ages 18-75. 4. Diagnosis of type 1 diabetes, based on a clinical diagnosis with onset at least 3 months prior to screening. 5. Using an automated insulin delivery system (AID) or multiple daily injections (MDI), (defined by use of rapid analogue with meals and approved long-acting analogue (e.g. detemir or glargine)). 6. Most recent eGFR ≥25 (and within prior 12 months). 7. HbA1c 7-\<-9%. 8. Have never used SGLT2i medications. 9. Must be willing and able to wear a DGK device and willing to follow the study protocol. 10. Must be able to read and speak English. 11. Use of adequate contraception for the duration of the study be the women of childbearing potential. 12. Access to necessary resources for participating in a technology-based intervention (i.e., computer, smartphone, internet access). Exclusion Criteria: 1. Pregnant, lactating, or planning to become pregnant or unwillingness to be on contraception during the trial. 2. Any form of diabetes other than T1D. 3. Any history of use of sodium-glucose cotransporter inhibitors and use of other non-insulin glucose lowering medication within the last 6 months. 4. Chronic systemic corticosteroids (\>4 consecutive weeks) within 6 months before screening or planned use during the study period. 5. History of diabetic ketoacidosis within 3 months of screening or 2 or more episodes of DKA within the last year. 6. History of multiple (≥ 3 infections) genital mycotic or bacterial infections within 6 months of screening or any history of necrotizing fasciitis. 7. Hypotension at screening as defined as, systolic blood pressure \< 90 and diastolic blood pressure \< 60 with symptoms of low blood pressure (confusion, dizziness, lightheadedness, fainting, heart palpitations). 8. History of a level 3 hypoglycemic event (as defined by ADA criteria) within 3 months of screening. 9. Recent myocardial infarction, stroke, hospitalization for unstable angina or heart failure within 3 months prior to screening. 10. New York Heart Association Class IV heart failure. 11. CKD-EPI estimated glomerular filtration rate (eGFR) \<25 mL/min/1.73m2. 12. Impairment of systems and organs that may increase their risk of participating in the intervention study or compromise the results (for example: end stage kidney disease, active liver dysfunction, gastroparesis, anemia, organ transplant). 13. Active Hepatitis B or C, or tuberculosis. 14. Abnormal liver function at screening defined as any of the following: aspartate aminotransferase (AST) \>2X upper limit of the normal reference range (ULN), ALT \>2X ULN, serum total bilirubin (TB) \>1.5X ULN. 15. History of severe acquired immune deficiency syndrome or human immunodeficiency virus (HIV) infection or severely immunocompromised status, in the opinion of the investigator, including, but not limited to patients who have undergone organ or bone marrow transplantation. HIV positive patients who are on stable immunosuppressive therapy and have undetectable viral load may be eligible for inclusion in the study, subject to the investigator's discretion. 16. Current or past history of decompensated cirrhosis (defined as variceal bleeding, ascites or hepatic encephalopathy), and/or known diagnosis of cirrhosis. 17. Cancer treatment (excluding non-melanoma skin cancer treated by excision, carcinoma in situ of the cervix or uterus, ductal breast cancer in situ, resected non-metastatic breast or prostate cancer) within one year of screening. 18. History of kidney transplant. 19. Chronic kidney disease (CKD) from a known cause other than T1D. 20. Current or clinically significant history of an eating disorder. 21. BMI \<22 at time of screening. 22. Adherence to a very low carbohydrate or ketogenic diet (\<100g carbohydrate /day) and unwilling to change during study participation. 23. History of foot amputation. 24. Non-healing wounds of extremities. 25. Documented medical adhesive allergy, as evaluated by investigator. 26. Inability to perform the study follow up or unwilling to wear the DGK device. 27. Heavy alcohol use (for men, ≥5 drinks on any day or ≥15 drinks per week; for women, ≥4 drinks on any day or ≥8 drinks per week) at screening, history of alcohol use disorder or binge drinking. 28. Participation in another treatment or intervention study within the past six weeks. 29. Any condition or factor that would compromise the participant's safety or conduct of the study (for example: cognitive impairment, bipolar disorder, or eating disorder) or any other reason the PI deems that the patient should not be included.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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International Diabetes Center
Minneapolis, Minnesota, 55416, United States
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Other studies related to the condition(s) this trial covers.
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