Clinical Research Directory

Key Inclusion Criteria: * Participants \>= 18 years of age * Fasting plasma C-peptide levels \<0.6 ng/ml * Average TIR \< 70% at the end of the screening period * Currently on a hybrid closed loop device for at least 3 months and willing to stay on the same model of pump device for study duration * Willing to wear a study provided CGM for study duration * Capable of participating in a 30-minute lasting exercise test Key Exclusion Criteria: * Have Type 2 Diabetes Mellitus (DM), monogenic diabetes, maturity-onset diabetes, other unusual or rare forms of DM, or diabetes resulting from a secondary disease. * Have been hospitalized for DKA within 3 months * Have uncontrolled hypothyroidism or hyperthyroidism * Have QTcF interval \> 450 msec for males or \> 470 msec for females * Have a personal or family history of long QT syndrome, Torsades de pointes, or other complex ventricular arrhythmias * Have persistent, uncontrolled hypertension * Have clinically significant cardiovascular or cerebrovascular disease * Have proliferative retinopathy or maculopathy requiring acute treatment * Have a serious concomitant systemic disorder incliuding but not limited to HIV or active Hep B or Hep C * Diagnosed and/or treated for malignancy within 3 years * Have used any of the following medications within the specified time periods: any non-insulin anti-diabetic therapies (e.g.SGLT-2 inhibitors, GLP-1 receptor agonists, metformin, sulfonylureas, DPP-4 inhibitors, pramlintide, a-glucosidase inhibitors, or glucose dependent insulinotropic polypeptide agonists) within 30 days, antipsychotic medications (e.g. olanzapine, risperidone, clozapine, quetiapine, and haloperidol) within 30 days, systemic corticosteroids for ≥7 days for a temporary medical condition within 30 days,