1189-P: Challenges Recruiting Adolescents and Young Adults (AYA) with Type 1 Diabetes and Higher A1Cs for Clinical Research

Introduction: Recruiting a representative study sample is critical but can be challenging. We assessed potential differences between AYA with T1D who consented vs declined to participate in a 2-year RCT aimed at improving glycemic outcomes and reducing diabetes distress.

Methods: AYA were recruited at 2 US sites for a study involving monthly virtual 1-1 psychoeducational sessions. Eligibility criteria included age 14-25 years, T1D ≥1 year, and A1c 7-13%.

Results: Over 15 months, we approached 482 potential participants; 217 (45%) consented, 232 (48%) declined, and 33 (7%) were ineligible. Most AYA were identified via clinic schedules (77%). Other recruitment methods were: participation in a previous study (14%), recruitment flyer (5%), provider referral (4%), and social media (1%). Reasons for decline were: too busy/not a good time (n=41, 18%), not interested (n=29, 13%), other/no reason given (n=7, 3%), and passive decline (expressed interest but no decision before enrollment closed) (n=155, 67%). There was no difference in the number of contacts made to those who consented vs declined (median=2 for both, range=1-8). Limited demographic data at 1 site for 217 potential participants (105 consented, 112 declined) showed no difference in % consented according to age (14-18 years: 46% consented; 19-25: 50% consented; p=.58) or SES using Social Deprivation Index (higher SES: 47% consented; lower SES: 51% consented; p=.49). However, there was a difference by A1c (7-8.4%: 59% consented; 8.5-13%: 39% consented; p=.002). Further, 65% of those with A1c 8.5-13% who declined were passive declines (compared to 51% of decliners with A1c 7-8.4%), suggesting that they had some interest but no follow-through. Number of contacts did not differ by age, SES, or A1c.

Conclusion: AYA with suboptimal glycemic control, often the target of research, may hesitate to participate in clinical trials. Creative outreach and extra effort (e.g., more contacts) may help to recruit them for future studies.