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AIDA is an interactive educational diabetes simulator that is useful for recreating clinically realistic diabetes situations. It is available without charge from http://www.2aida.org on the Web. This paper describes a prospective, clinical randomised-controlled trial (RCT) run at the Ospedale di Marino (Italy) for evaluating the educational utility of AIDA in small group teaching sessions. Twenty-four volunteers (12 male and 12 female) with Type 1 diabetes of more than 6-year duration, aged 19-48 years, who gave written informed consent, were randomly assigned to one of two study groups, each receiving different teaching interventions. Group A was exposed to the AIDA diabetes simulator, while Group B (the control group) received conventional lessons with slides and transparencies. Six lessons were held for each group (one per week). At the end of the conventional lessons, after a 'washout' period of 4 weeks, Group B entered a partial cross-over phase with the simulator during a further 6-week block of lessons. Before and after the 6 weeks of lessons, twice for Group A and 3 times for Group B, all subjects had their HbA1c measured. The subjects also carefully documented the incidence of any symptomatic hypoglycaemic episodes ('hypos'), whether mild (sweating, dizziness), moderate (nausea, vomiting), or severe (requiring assistance). All data were analysed using non-parametric statistics (Wilcoxon signed rank tests). HbA1c levels in Group A dropped significantly from 7.2% to 6.4% after lessons with the diabetes simulator (p = 0.01). No significant changes in HbA1c were observed in Group B between baseline (7.1%) and the end of the control lessons (7.0%), or the end of the cross-over phase lessons (6.8%). The number of 'hypos' decreased significantly from 31 to 14 in Group A (p = 0.03) after AIDA lessons, but did not change significantly in Group B from baseline (n = 20) to after the control lessons (n = 22). However, the number of 'hypos' did decrease significantly (to n = 10) in Group B after exposure to the simulator during the cross-over phase (p = 0.03 vs 6-week data). Larger trials involving more patients in more centres are clearly needed, but this proof-of-concept (pilot) study does demonstrate the feasibility of using a prospective RCT approach for the evaluation of educational diabetes simulation software such as AIDA.