Abstract

BACKGROUND
Type 1 diabetes mellitus (Type 1 DM) results from autoimmune destruction of -cells of the pancreas. Many treatments aimed at inducing remission of newly diagnosed type 1 DM or preventing of type 1 DM in high risk group are being conducted. BCG is known to modulate the development of spontaneous diabetes in animal model of type 1 DM. In some studies, single injection of BCG induced clinical remission in recent onset type 1 DM patients. However, the effect of BCG on human is still controversial. Thus, we performed a prospective study to evaluate the effect of BCG on type 1 DM. METHODS: We enrolled a total of 23 type 1 DM patients within 6 months period. Randomly selected 14 patients were injected 0.1 ml BCG intradermally and 9 patients were injected normal saline. Fasting and postprandial 2 hour C-peptides, and insulin requirements were measured in all patients at enrollment and at 6, 12 and 24 months after BCG vaccination. RESULTS: At enrollment, there was no significant difference in age, sex, duration of diabetes, HbA1-C, body mass index, fasting and postprandial 2 hour C-peptides, and insulin requirement between BCG group and control group. During follow-up, there was no significant difference in fasting and postprandial 2 hour C-peptides. However postprandial 2 hour C-peptides in BCG group were higher than those in control group at 12 and 24 months (p-value>0.05). Insulin requirements also were lower in BCG group than in control group at 12 and 24 months (p-value>0.05). Clinical remission has been sustained in 2 BCG vaccinated patients at 6 and 12 months. In one of the two patients, remission was sustained for 36 months. CONCLUSION: BCG vaccine is safe and convenient to use, however, a large study is warranted for the use of BCG as a therapy of type 1 DM.

• Keywords: Type 1 diabetes mellitus;BCG;Immunotherapy;