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


METHODS
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.


RESULTS
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.


CONCLUSIONS
These results suggest that trial involvement benefits the young person's approach to self-management of diabetes.
McGuinness
Claire
C
Glasgow Caledonian University.
Cain
Melanie
M
D000293:Adolescent; D001294:Attitude to Health; D002648:Child; D002986:Clinical Trials as Topic / Q000523:psychology*; D003922:Diabetes Mellitus, Type 1 / Q000188:drug therapy / Q000523:psychology*; D016903:Drug Monitoring / Q000379:methods / Q000523:psychology; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use; D007328:Insulin / Q000627:therapeutic use; D007494:Ireland; D015337:Multicenter Studies as Topic / Q000523:psychology; D015404:Nursing Methodology Research; D000297:Psychology, Adolescent; D002666:Psychology, Child; D012646:Self Administration / Q000379:methods / Q000523:psychology; D011795:Surveys and Questionnaires; D006113:United Kingdom
D007004:Hypoglycemic Agents; D007328:Insulin