Studies to predict and prevent type 1 diabetes (T1D) are limited by small numbers and lack of participation from all affected populations. We compared TrialNet Pathway to Prevention recruitments at one pediatric center 12 months before (June 2021-May 2022, n=15) and after (June 2022-May 2023, n=319) implementation of knowledge-based interventions aimed at clinicians and participants to increase recruitment. Recruitment increased by over 20-fold, with higher enrollment for all reported races and ethnicities although the overall population was largely non-Hispanic and White. Effective interventions are still needed to overcome recruitment barriers in order to ensure that the enrolled population reflects the overall affected population.
Competing Interest StatementThe authors have declared no competing interest.
Funding StatementThis study used data from TrialNet, which has its own NIH funding, but the results presented here were not funded.
Author DeclarationsI confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.
Yes
The details of the IRB/oversight body that provided approval or exemption for the research described are given below:
The IRB of a central Institutional Review Board (IRB), OneIRB, at the University of South Florida gave ethical approval for this work.
I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.
Yes
I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).
Yes
I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.
Yes
Data AvailabilityAll data produced in the present study are available upon reasonable request to the authors, with consent as needed, by TrialNet.
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