Ketone Monitoring Approaches for Diabetic Ketoacidosis Risk Mitigation in People With T1D on Adjunctive SGLT-2 Inhibitors

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-40
SponsorAdventHealth Translational Research Institute

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)

Treatment groups

75 Participants
are divided into 1 treatment group