BCG in treatment of newly diagnosed type 1 diabetic patients

Type 1 diabetes is believed to be an autoimmune disease. Pancreatic islet cell destruction occurs by infiltration of T lymphocytes. BCG vaccine modulates the development of type 1 diabetes in animal models. Based upon the studies in animals and man a clinical trial using a single dose of BCG vaccine was carried out in newly diagnosed type 1 diabetic patients. Ten newly diagnosed type 1 diabetic patients 4-14 years of age, were enrolled in this study. All patients had been vaccinated with BCG at birth. PPD positive patients and those with other autoimmune diseases were excluded from this study. Single dose of BCG (0.1 ml of 1 mg/ml) was administered intracutaneously to all patients. Ten newly diagnosed type 1 diabetic patients matched for age and sex were also followed as the control group. All patients were followed with fasting blood sugar, HbA1c and the needed insulin per kg of body weight for nine months. There was no significant difference in fasting sugar, insulin dose & HbA1c levels at any time between the BCG-vaccinated and control groups. Our study does not support the effect of BCG therapy in this group of diabetic patients.