Checkpoint Inhibitor Associated Diabetes Mellitus: Early Recognition and Treatment (CERT) Project: A Pilot Study

Eligibility Criteria * Participants on ICI referred to endocrine for new diagnosis of CIADM, will be included provided they are within 12 months of last dose of ICI and if they have: * New onset diabetes≥ 200 mg/dl and/or A1c ≥6.5 OR * Worsening glycemic control: requiring insulin per clinician assessment (fasting glucose or average glucose on CGM\>20% and /or A1c \>0.5% from prior to ICI use ) AND /OR * If Presenting with DKA/HHS: include if within 6 weeks of presentation AND * Must have detectable random c-peptide level 0.2 - 1 ng/mL with blood glucose of 145 mg/dl * Age ≥18 years. Because adverse event data are currently available on the use of infliximab in combination within participants \<18 years of age, children are excluded from this study. * ECOG performance status ≤2 (Karnofsky ≥60%,). * Participants must have adequate organ and marrow function as defined below: absolute neutrophil count ≥1,000/mcL platelets ≥100,000/mcL total bilirubin ≤ institutional upper limit of normal (ULN) AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN creatinine ≤ institutional ULN Cardiac ejection fraction \> 50% * Participants with a prior or concurrent malignancy whose natural history or treatment does not interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. * Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine…