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.
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
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
Sequential
SGLT-2 inhibitor (Sotagliflozin)
DrugParticipants will be asked to take the SGLT-2 inhibitor.
Insulin withdrawal test (IWT)
Other interventionAn Insulin withdrawal test (IWT) will be given to participants on an SGLT-2 inhibitor. Participants will be monitored.
Ketone events with Beta-hydroxybutyrate (BOHB) >1.5 mmol/L
Number of ketone events with BOHB \> 1.5 mmol/L for 15 consecutive minutes, as measured by the DGK. The event will end when BOHB is \< 1.5 for 15 consecutive minutes. These events will be measured during the risk mitigation phase (Period 3 and Period 4) of the study.
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