Ketone Monitoring Approaches for Diabetic Ketoacidosis Risk Mitigation in People With T1D on Adjunctive SGLT2 Inhibitors
AdventHealth Translational Research Institute
Summary
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.
Eligibility
- Age range
- 18–40 years
- Sex
- All
- Healthy volunteers
- Yes
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 diab…
Interventions
- DrugSGLT-2 inhibitor (Sotagliflozin)
Participants will be asked to take the SGLT-2 inhibitor.
- OtherInsulin withdrawal test (IWT)
An Insulin withdrawal test (IWT) will be given to participants on an SGLT-2 inhibitor. Participants will be monitored.
Location
- AdventHealth Translational Research InstituteOrlando, Florida