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

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.

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