Ketone Monitoring Approaches for Diabetic Ketoacidosis Risk Mitigation in People With T1D on Adjunctive SGLT-2 Inhibitors
Ketone Monitoring Approaches for Diabetic Ketoacidosis Risk Mitigation in People With T1D on Adjunctive SGLT2 Inhibitors
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 40 Years
- Sex
- All sexes
- Healthy volunteers
- 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 compares a special teaching plan with general teaching for adults with type 1 diabetes who will take SGLT2 medicines. The special plan uses a device that tracks ketones, chemicals that can build up in the blood. Researchers want to see if it lowers the risk of diabetic ketoacidosis (DKA), a dangerous acid buildup that is more likely with these medicines.
The purpose of this research is to see how well a special education plan using continuous ketone monitoring (DGK) works to lower the risk of a condition called diabetic ketoacidosis (DKA) in people with type 1 diabetes (T1D) taking SGLT2 inhibitors (a type of medication commonly used to treat type 2 diabetes). This special education plan is compared to a general education plan and considers the higher risk of DKA when using medicines like SGLT2 inhibitors.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Age 18 or older and not pregnant.
- Have type 1 diabetes that meets American Diabetes Association guidelines.
- Have an HbA1c below 9%. This blood test shows your average blood sugar over time.
- Use several insulin shots each day, an insulin pump, or an advanced insulin delivery system.
- Sign a consent form agreeing to join the study.
- Be willing to wear the study device.
- Use suitable birth control during the study if you can become pregnant.
Who can't join
- Are pregnant, breastfeeding, or planning pregnancy; have diabetes other than type 1; use weekly insulin; or used SGLT2 medicines in the 4 weeks before screening.
- Used steroid medicines that affect the whole body for more than 4 weeks in a row within the past 6 months.
- Had DKA or at least 3 genital yeast infections in the past 6 months, or a severe low blood sugar event in the past 3 months.
- Have blood pressure below 90/60 with symptoms; had a heart attack, stroke, or hospital stay for unstable chest pain or heart failure in the past 3 months; or have the most severe class of heart failure.
- Have very low kidney function (eGFR below 30), liver scarring, certain high liver blood test results, an organ transplant, or other organ problems that could make the study unsafe or affect results.
- Had cancer treatment in the past year, with exceptions for certain cancers; have active hepatitis B or C, tuberculosis, or AIDS. HIV controlled with medicines is allowed.
- Have heavy alcohol use: for men, at least 5 drinks in a day or 15 a week; for women, at least 4 in a day or 8 a week. A history of alcohol use disorder or binge drinking also rules you out.
- Have another condition that could affect safety or study results, such as problems with thinking, bipolar disorder, or a past eating disorder; cannot complete follow-up visits; will not wear the device; or will not get at least 20% of calories from carbohydrates.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: 1. Men and nonpregnant women ≥18 years and older 2. Diagnosis of T1D according to American Diabetes Association (ADA) criteria 3. HbA1c \< 9 % 4. Participants treated with multiple daily injections of insulin, insulin pump, or advanced insulin delivery systems 5. Has provided written informed consent to participate in the study. 6. Must be willing to wear the investigational device 7. Use of adequate contraception for the duration of the study by women of childbearing potential Exclusion Criteria: 1. Pregnancy, lactation or planning to become pregnant 2. Any form of diabetes other than T1D 3. People with T1D using weekly insulin (when approved) 4. Use of sodium-glucose cotransporter 2 inhibitors within 4 weeks prior to screening 5. Chronic systematic corticosteroids (\>4 consecutive weeks) within 6 months before screening 6. History of diabetic ketoacidosis within 6 months of screening 7. History of multiple (≥ 3 infections) genital mycotic infections within 6 months of screening 8. Hypotension at screening is defined as systolic blood pressure \< 90 and diastolic blood pressure \< 60 with symptoms of low blood pressure (confusion, dizziness, lightheadedness, fainting, heart palpitations) 9. History of a level 3 hypoglycemic event (as defined by ADA criteria) within 3 months of screening 10. Recent myocardial infarction, stroke, hospitalization for unstable angina or heart failure within 3 months prior to screening 11. New York Heart Association Class IV heart failure 12. CKD-EPI estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m² 13. 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. 14. 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 15. Active Hepatitis B or C, acquired immunodeficiency syndrome (HIV infection controlled with suppressive medications is allowed) or tuberculosis 16. 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 17. Current or past history of decompensated cirrhosis (defined as variceal bleeding, ascites, or hepatic encephalopathy), and/or known diagnosis of cirrhosis 18. 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 19. Any condition or factor that would compromise the participant's safety or the scientific integrity of the study (cognitive impairment, bipolar disorder, or history of eating disorder) 20. Inability to perform the study follow up/ unwilling to wear the investigational device 21. People who are unwilling to consume at least 20% of calories from carbohydrates
Study sites (1)
FL
- AdventHealth Translational Research Institute · Orlando, FL 32804More trials in Orlando