| Outcome Measures: |
Primary: Change in Blood Glucose Levels, Evaluation for hypoglycemia will be measured prior to administration of the insulin (baseline), then at 30, 60, and 120 minutes after administration of the insulin., Day 1|Daily Evaluation of Blood Glucose Levels, Blood glucose will be measured 60 minutes after the administration of the Insulin., Days 2 through 7|Evaluation of Blood Glucose Levels, After treatment day 7, Insulin will be administered and measured on a monthly basis., Measured 60 minutes after oral insulin dosing, every day during each 4th week, as long as the subject is given oral insulin. | Secondary: Change in Total IgE and IgE., Allergy/intolerance to the study drug evaluated with total IgE and IgE antibodies to insulin at 2 weeks, 3 months, 6 months, then every 6 months thereafter, as well as monitored through self-reporting by families. Parents/guardians will be educated on and instructed to look out for possible allergic reactions to insulin., 2 weeks, 3 months, 6 months|T-cell responses related to potential immune response to Insulin, T-cell responses e.g. antibody and cell mediated immune results will be evaluated the day of administration then at 15 days, 3 and 6 months, and every 6 months of treatment, and will be reported directly to the Data Coordinating Center., Day 1, 15 days, 3 and 6 months.
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