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): 4.0-17.0,  Diabetes Mellitus, Insulin-Dependent Girls/boys, 4-17 years, inclusive Girls not yet of childbearing potential or, if sexually active, agree to use reliable medically accepted contraceptive measure during study Type 1 diabetes mellitus established in medical history: for example, but not limited to, clear signs of insulinopenia (polyuria, polydipsia, polyphagia, weight loss, ketonuria, ketoacidosis); or glutamic acid decarboxylase (GAD) antibody indicative of type 1 diabetes measured at any time before study; or requiring continuous insulin therapy from time of diagnosis Onset of diabetes at least 1 year prior to visit 1 (V1) of study Uninterrupted insulin therapy for at least 1 year before V1 of study At V1, on stable insulin regimen of either NPH or insulin glargine as basal insulin and willing to have multiple daily injections of insulin Glycated hemoglobin at V1 between ≥ 6.0 and ≤11.0 % Ability/willingness to do blood glucose monitoring using sponsor-provided glucometer and subject diary  Active proliferative diabetic retinopathy, defined by application of focal or panretinal photocoagulation or vitrectomy, 6 months before V1, or any other unstable/rapidly progressing retinopathy requiring surgical treatment (including laser photocoagulation) during study Diabetes other than type 1 diabetes mellitus Pregnancy (positive pregnancy blood test at V1) or breastfeeding Pancreatectomized subjects Subjects who have had pancreas and/or islet cell transplants Treatment with any anti-diabetic oral agent at any time from diabetes diagnosis Treatment with systemic corticosteroids in last month before V1 Subjects on pump therapy during last 2 months before V1 Subjects requiring excessively high doses of insulin ("resistant" patients), for example, but not limited to, subjects receiving over 150 IU per day Likelihood of needing treatment during study period with drugs not permitted by protocol