Mitigating DKA in Type 1 Diabetes for Safe Use of SGLT Inhibitors Using Dual Continuous Ketone and Glucose Monitoring.
Mitigating Diabetic Ketoacidosis in People With T1D and Chronic Kidney Disease on an SGLT1&2 Inhibitor: Ketosis Risk Factor Determination and Incorporation Into an Enhanced Glucose Ketone Report
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 75 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Mentioned in the study description
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Mentioned in the study description
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether a sensor that tracks blood sugar and ketones can help people with type 1 diabetes use SGLT2 medicines more safely. Ketones are chemicals that can build up and cause diabetic ketoacidosis (DKA), a dangerous acid buildup in the blood. The study includes adults with different levels of kidney health and lasts nine months.
The goal of this clinical trial is to develop and evaluate a novel diabetes ketoacidosis risk mitigation strategy to support the safe use of sodium-glucose cotransporter-2 inhibitors (SGLT2i) therapy in participants with type 1 diabetes (T1D) and mild to moderate chronic kidney disease (CKD). The main objectives of this study are to: 1. Evaluate how ketone metrics differ between participants no chronic kidney disease (CKD), moderate risk CKD and high or very high-risk CKD in three time periods. 2. Identify potentially modifiable ketosis risk factors. 3. Use continuous dual ketone and glucose monitoring (DGK) data prior to and following treatment to determine ketosis risk factors and gain knowledge to further refine reporting of risk factors and determine which factors in the Ketone Action Plan (KAP) were most valuable. 4. Gather information on how participants and clinicians like and use the DGK reports. Participants will be asked to: * Meet with study investigators to determine if they are eligible * Sign written informed consent * Take a pregnancy test, if applicable * Have blood taken to assess kidney function and hemoglobin A1c * Take the study medication, following the study team instructions * Wear the study provided sensor throughout participation. * Complete 5 in person visits, and 11 phone check ins over a nine-month period * Provide feedback on their experience, usefulness of CGM/CKM reports, and the most valuable factors of the Ketone Action Plan (KAP).
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be 18–75 years old and have had type 1 diabetes for at least 3 months.
- Use an automated insulin delivery system or daily shots of both mealtime and long-acting insulin.
- Have a kidney filtering score, called eGFR, of at least 25 from the past 12 months.
- Have an A1c of 7% to less than 9%. This blood test shows your average blood sugar.
- Have never used an SGLT2 medicine.
- Agree to wear the blood sugar and ketone sensor, follow study steps, and sign a consent form.
- Read and speak English and have access to a computer, smartphone, and internet.
- Use suitable birth control throughout the study if you could become pregnant.
Who can't join
- Be pregnant, breastfeeding, planning pregnancy, or unwilling to use required birth control.
- Have diabetes other than type 1, past use of SGLT medicines, or use of other non-insulin diabetes medicines in the past 6 months.
- Have DKA in the past 3 months, at least 2 DKA episodes in the past year, or a severe low blood sugar event in the past 3 months.
- Have a kidney filtering score below 25, a kidney transplant, or kidney disease caused by something other than type 1 diabetes.
- Have certain serious health problems, such as recent heart attack or stroke, severe heart failure, liver disease, active infections, or a very weak immune system. Certain recent cancer treatments also rule you out.
- Have a BMI below 22, an eating disorder, heavy alcohol use or a history of alcohol use disorder or binge drinking. Eating less than 100 grams of carbs daily also rules you out if you will not change your diet.
- Have a past foot amputation, wounds on arms or legs that do not heal, an allergy to medical adhesive, or certain repeated genital infections.
- Use long-term steroid medicines as described in the study rules, join another treatment study within the past 6 weeks, or be unable to wear the sensor or complete follow-up. Other conditions that make participation unsafe may also rule you out.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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.
Study sites (1)
MN
- International Diabetes Center · Minneapolis, MN 55416Rebecca Passi · Study contact · 1-952-993-3452 · passir@healthpartners.comMore trials in Minneapolis