Patient description: The patient is a 24-year-old man who has had type 1 diabetes for 11 years. He presents to the emergency room with hyperglycemia and concern for possible diabetic ketoacidosis after not taking his insulin for 3 days. The patient reports that he is currently homeless and has lost his supply of insulin, syringes, glucometer, and glucose testing supplies. The patient states that at the time of his initial diagnosis with type 1 diabetes he was hospitalized with a glucose value >1000 mg/dL. At the time, he was experiencing polyuria, polydipsia, and polyphagia. He reports that he has been on insulin since the time of his diagnosis, and he has never been prescribed oral agents for diabetes management. Most recently, he has been using insulin glargine 55 units once daily, and insulin aspart sliding scale 3 times daily. The patient has had previous episodes of diabetic ketoacidosis, for which he was hospitalized. With this episode of hyperglycemia, he is not experiencing any nausea, vomiting, or abdominal discomfort, and he appears well. His lab studies showed: A1c: 11.3% Creatinine: 0.9 mg/dL with eGFR >60 mL/min Aspartate aminotransferase (AST): 17 U/L Alanine aminotransferase (ALT): 14 U/L Beta-hydroxybutyrate: 0.1 mmol/L Bicarbonate: 25 mEq/L Anion

Clinical trial eligibility criteria: eligible ages (years): 3.0-45.0,  Diabetes Mellitus, Type 1 Have a proband with Type 1 diabetes mellitus (T1DM). A proband is an individual diagnosed with diabetes before age 40 and started on insulin therapy within 1-year of diagnosis. Probands considered to have type 1 diabetes by their physician who do not meet this definition will be referred to the TrialNet Committee. 2. If the proband is a parent, sibling or a child, the study participant must be 3 -45 years of age. If the proband is a second or third degree relative (i.e. niece, nephew, aunt, uncle, grandparent, cousin, or half-sibling), the study participant must be 3-20 years of age. 3. Willing to sign Informed Consent Form. 4. Oral glucose tolerance test (OGTT) performed within 7 weeks prior to randomization in which fasting plasma glucose < 110 mg/dL (6.1 mmol/l), and hour plasma glucose < 140 mg/dL (7.8 mmol/l) 5. mIAA confirmed positive within the previous six months. 6. Two samples with at least one autoantibody other than mIAA positive within the previous six months  Does not satisfy the above criteria. Subjects with mIAA positive but no other autoantibodies positive are not eligible for randomization. 2. Has severe active disease, e.g. chronic active hepatitis, severe cardiac, pulmonary, renal, hepatic, immune deficiency and/or disease that is likely to limit life expectancy or lead to therapies such as immunosuppression during the time of the study. 3. Prior participation in a trial for prevention of T1DM, e.g. nicotinamide, insulin, immunosuppressive drugs. 4. History of treatment with insulin or oral hypoglycemic agent. 5. History of therapy with immunosuppressive drugs or glucocorticoids within the past two years for a period of more than three months. 6. Ongoing use of medications known to influence glucose, i.e. sulfonylureas, growth hormone, metformin, anticonvulsants, thiazide or potassium depleting diuretics, beta adrenergic blockers, niacin. Subjects on such medications should be changed to a suitable alternative, if available, and will become eligible one month after medication is discontinued. 7. Pregnant or intends to become pregnant while on study or lactating. 8. Deemed unlikely or unable to comply with the protocol. 9. OGTT that reveals Diabetes, Impaired Glucose Tolerance (IGT), or Impaired Fasting Glucose (IFG). Diabetes is defined by fasting plasma glucose ³ 126 mg/dL (7 mmol/l), OR hour plasma glucose ³ 200 mg/dL (11.1 mmol/l) IGT is defined by fasting plasma glucose < 126 mg/dL (7 mmol/l), and hour plasma glucose 140-199 mg/dL (7.8 mol/l), IFG is defined by fasting plasma glucose 110-125 mg/dL (6.1-6.9 mmol/l) AND hour plasma glucose < 140 mg/dL (7.8 mmol/l) 10. Subject has HLA DQA1*0102, DQB1*0602 haplotype