Abstract

OBJECTIVE -- To assess participant and parent experiences in the parenteral insulin arm of the Diabetes Prevention Trial -- Type 1 (DPT-1).

RESEARCH DESIGN AND METHODS -- Before trial results were publicized, surveys were completed by 82 Intervention participants (who received annual 4-day insulin infusions and daily insulin injections), 81 Closely Monitored controls, and 135 parents of children in the trial.

RESULTS -- Survey results suggest participant perspective (adult, child, parent, and gender), study procedures, and group assignment have important implications when planning clinical trials. Parents rated the trial more favorably but worried about hypoglycemia and diabetes onset. Children had the least favorable reaction to the study. Parents preferred assignment to the Intervention group; child/adult participants preferred assignment to the Closely Monitored group. The Intervention group rated the annual 4-day insulin infusions more negatively than all other study procedures. Intervention participants/parents reported poorer insulin injection adherence over the course of the study. Intervention group participants, parents, and females expressed an interest in additional psychosocial support during the trial. Random assignment was viewed negatively by both study groups. Close observation for diabetes onset was viewed as the most favorable aspect of the study. Behaviors outside of the study protocol to prevent or delay diabetes onset were common and should be monitored in future prevention studies.

CONCLUSIONS -- Overall, most participants were positive about the trial and many expressed optimism about the intervention's potential for success. These results have implications for study design, recruitment and retention procedures in future prevention trials. ClinicalTrials.gov Identifier: NCT00004984