The general purpose of this proposal is to perform a hypoglycemia awareness study in Bulgaria as a parallel to an ongoing study in the US. This will test the validity of the parent grant findings without the confounding influence of home glucose monitoring and encourage an interaction with Bulgarian diabetologists. The study will consist of three phases. Phase 1 will recruit and compare Type I DM patients with severe hypoglycemia (SH) vs. no SH. Phase 2 will develop a three arm treatment program intended to prevent SH. Phase 3 will involve a long term evaluation of patients from Phase 2. Interventions and data collection include psychometric testing following a paradigm of the parent grant, the use of glucose monitoring, and an ingenious hand held computer to collect data. In addition, hypoglycemia diaries will be obtained. Interventions (in Phase 2) include routine care (Grp I), glucose monitoring (Grp 2), and classroom education (Grp III). The data will be extensively analyzed using paradigms and models developed for the Parent grant.
Cox, Daniel J; Singh, Harsimran; Lorber, Daniel et al. (2013) Diabetes and driving safety: science, ethics, legality and practice. Am J Med Sci 345:263-265 |