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Recruiting young pre-symptomatic children for a clinical trial in type 1 diabetes: Insights from the Fr1da insulin
Kerstin Kick1, Robin Assfalg2, Susanne Aydin1
1Forschergruppe Diabetes, Technical University Munich, at Klinikum rechts der Isar, Munich, Germany.
Insights
Recruiting children for type 1 diabetes prevention trials is challenging. Families cited time constraints and blood draws as primary reasons for non-participation, highlighting the need for improved trial designs.
Area of Science:
- Pediatric Endocrinology
- Clinical Trial Recruitment
- Diabetes Prevention Research
Background:
- Early detection of type 1 diabetes is possible, but no approved therapies exist to delay or prevent its onset.
- Developing evidence-based interventions is crucial for preventing type 1 diabetes.
- Recruiting sufficient participants, especially asymptomatic children, for clinical trials remains a significant challenge.
Purpose of the Study:
- To identify family characteristics influencing participation in type 1 diabetes intervention trials.
- To analyze the reasons families decline participation in such studies.
Main Methods:
- Recruitment from the population-based Fr1da study for early-stage type 1 diabetes in Bavaria.
- Analysis of factors: child's sex and age, family distance to study center, and family history of type 1 diabetes.
- Phone interviews with non-participating families to ascertain reasons for declining enrollment.
Main Results:
- 53% of eligible children were enrolled in the Fr1da Insulin Intervention study.
- No significant differences in tested family characteristics were found between participating and non-participating families.
- Families living closer to the study site were more likely to enroll; primary reasons for non-participation were time restrictions and the venous blood draw.
Conclusions:
- Identified factors for non-participation must inform future trial designs for young children to ensure adequate recruitment and valid results.
- Further research into the determinants of participation and non-participation in clinical trials is essential for advancing pediatric medical treatments.
Background:
Although detection of children at high risk of developing type 1 diabetes and diagnosis of early stages is possible, up to now there exists no approved therapy to delay or prevent type 1 diabetes. Thus it is vital to develop evidence-based interventions. For this a sufficient number of trial participants is crucial but difficult to obtain especially in asymptomatic children.
Aim:
Identifying family characteristics that lead to or impede trial participation and analyze reasons stated by families for non-participation.
Methods:
Participants for the Fr1da Insulin Intervention study are recruited from the Fr1da study, a population based screening for early stage type 1 diabetes in Bavaria. Families with eligible children were invited to enroll. We analyzed sex and age of the child, distance of the family to the study center in Munich and the existence of a first degree family member with type 1 as possible influential factors for study participation. We also analyzed reasons stated by families who declined study participation in a phone interview.
Results:
Of 146 eligible children 77 (53%) were enrolled into the trial. None of the tested family characteristics differed significantly between the enrolling and the families not participating, but in general enrolling families lived closer to the study site than families not participating. This is also reflected in the reasons given by non-participating families. The most frequent reason stated were time restrictions. The second most frequent reason was the venous blood draw.
Conclusion:
The factors for non-participation identified in this project need be taken into account for the design of future trials in young children to ensure proper recruitment and thus to generate valid results for medical treatment of children. More research on the reason of participation and non-participation in clinical trials is needed.
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