Participation in a clinical trial: views of children and young people with diabetes.

AiM: To investigate whether involvement in research can have a positive effect on the education and management of disease of children and young people with diabetes. METHOD: Children's and young people's experiences of exposure to intensified intervention during a clinical trial were examined by a questionnaire given to 44 young patients with type 1 diabetes from the UK and Ireland. The young people had participated in a trial comparing specific insulin regimes. Most patients were obliged to increase injection frequency, clinic attendance, glucose monitoring and diary entries. FINDINGS: Of the 44 patients, 36 completed the questionnaire. Most, including the younger children, did not regard basal-bolus therapy, additional injections or intensified self-monitoring as barriers to self-management. They also believed that the management of their diabetes was further supported as a result of increased contact and intensive insulin management. Many of the children participating in this study felt they had learned something about their diabetes, and, furthermore, almost all opted to remain on an intensive treatment regimen. CONCLUSION: These results suggest that trial involvement benefits the young person's approach to self-management of diabetes.