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Diabetes Technol Ther. 2016 Sep;18(9):568-73. doi: 10.1089/dia.2016.0157. Epub 2016 Jun 29.

Factors Affecting Recruitment of Participants for Studies of Diabetes Technology in Newly Diagnosed Youth with Type 1 Diabetes: A Qualitative Focus Group Study with Parents and Children.

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1 Cambridge Centre for Health Services Research, Institute of Public Health, School of Clinical Medicine, University of Cambridge , Cambridge, United Kingdom .
2 Department of Paediatrics, Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge , Cambridge, United Kingdom .
3 Department of Paediatric Endocrinology and Diabetes, Nottingham Children's Hospital, Nottingham University Hospitals NHS Trust , Nottingham, United Kingdom .
4 Department of Paediatric Endocrinology and Diabetes, Southampton Children's Hospital, University Hospital Southampton NHS Trust , Southampton, United Kingdom .



Relatively little is known about parents' or children's attitudes toward recruitment for, and participation in, studies of new diabetes technologies immediately after diagnosis. This study investigated factors affecting recruitment of participants for studies in newly diagnosed youth with type 1 diabetes.


Qualitative focus group study incorporating four recorded focus groups, conducted in four outpatient pediatric diabetes clinics in large regional hospitals in England. Participants comprised four groups of parents (nā€‰=ā€‰22) and youth (nā€‰=ā€‰17) with type 1 diabetes, purposively sampled on the basis of past involvement (either participation or nonparticipation) in an ongoing two-arm randomized trial comparing multiple daily injection with conventional continuous subcutaneous insulin infusion regimens from the onset of type 1 diabetes.


Stress associated with diagnosis presents significant challenges in terms of study recruitment, with parents demonstrating varied levels of willingness to be approached soon after diagnosis. Additional challenges arise regarding the following: randomization when study arms are perceived as sharply differentiated in terms of therapy effectiveness; burdens arising from study participation; and the need to surrender new technologies following the end of the study. However, these challenges were mostly insufficient to rule out study participation. Participants emphasized the benefits and reassurance arising from support provided by staff and fellow study participants.


Recruitment to studies of new diabetes technologies immediately after diagnosis in youth presents significant challenges, but these are not insurmountable. The stress and uncertainty arising from potential participation may be alleviated by personalized discussion with staff and peer support from fellow study participants.

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