Although NOD mice treated with Ins-RT-NP exhibit Foxp3 positivity at 22 weeks from the time of the last microparticle injection (data not shown), in the absence of age-matched diabetes-free and age-matched new-onset diabetic mice treated with the control test articles, it is currently not known if the frequency of Tregs or Bregs changes longitudinally resulting in a greater population of these cells inside the PLN and/or the MLN of Ins-RT-NP-treated mice. The gene discussed is FOXP3; the disease is diabetes mellitus.