The purpose of this study is to measure change in glycemic control and insulin needs with Teplizumab compared with placebo. The intervention, either Teplizumab or placebo, will be administered by intravenous (IV) infusion, to participants recently diagnosed with stage 3 type 1 diabetes (T1D) aged 1 to 25 years.

Teplizumab, also known as Tzield, is currently approved for use in stage 2 type 1 diabetes, to delay the onset of stage 3 T1D in adults and children eight years and older. Teplizumab is the first and only disease modifying therapy in autoimmune T1D.

The goal of this Phase 2 study is to assess safety and efficacy of frexalimab to preserve -cell function in participants with newly diagnosed type 1 diabetes (T1D). We are currently enrolling ages 12-21.

Insulin therapy, commonly given as multiple daily injection therapy, is the only recommended treatment for Cystic Fibrosis Related Diabetes (CFRD). Traditional therapy for CFRD requires an intense daily effort related to diabetes care on top of the already burdensome management of Cystic Fibrosis. In this study, we will assess the safety and effectiveness of the iLet Bionic Pancreas, an automated insulin delivery system, which uses a continuous glucose monitor (CGM), an insulin pump, and a control formula that activates insulin delivery based on CGM glucose data.