About this trial
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 criteria
Qualifiers
Men and nonpregnant women ≥18 years and older
Diagnosis of T1D according to American Diabetes Association (ADA) criteria
HbA1c < 9 %
Participants treated with multiple daily injections of insulin, insulin pump, or advanced insulin delivery systems
Disqualifiers
Pregnancy, lactation or planning to become pregnant
Any form of diabetes other than T1D
People with T1D using weekly insulin (when approved)
Use of sodium-glucose cotransporter 2 inhibitors within 4 weeks prior to screening
Trial design
Treatments tested in this trial
- SGLT-2 inhibitor (Sotagliflozin)
- Insulin withdrawal test (IWT)