Recruitment Into a Pediatric Continuous Glucose Monitoring RCT

Abstract

Background: The purpose was to identify patient/family characteristics and recruitment process characteristics associated with the decision to participate in a 2-year continuous glucose monitoring (CGM) RCT for youth with type 1 diabetes and their families.

Method: Study staff approached patients who were conditionally eligible according to medical record review or referred by a provider. We categorized families according to participation decision (agree vs decline) and timing of decision (day of approach vs later ["thinkers"]).

Results: Over 18 months, we approached 456 eligible patients; 19% agreed on the day of approach, 10% agreed later, 42% declined on the day of approach, and 30% declined later. Agreers were younger ( P = .002), had shorter diabetes duration ( P = .0003), had a lower insulin dose ( P = .02), checked blood glucose levels more often ( P = .002), and were more likely to use pump therapy ( P = .009) than decliners. Patients/families were more likely to agree in fall/winter (41%) than spring/summer (19%, P < .0001). Of decliners, 50% cited no interest in CGM as the reason for nonparticipation. Among thinkers, 49% of patients who made a decision within 2 weeks of being approached agreed; only 15% of thinkers who made a decision >2 weeks after being approached agreed to participate ( P < .0001).

Conclusions: Recruitment is a critical and often challenging phase of clinical trials. Recruitment to pediatric CGM studies may be especially challenging due to youths' reluctance to use CGM. These data provide an opportunity to better understand and possibly optimize recruitment into future pediatric CGM studies and other studies of advanced diabetes technologies.

Keywords: clinical research; continuous glucose monitoring; pediatrics; recruitment; type 1 diabetes.

Conflict of interest statement

Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: LML reports participation as a consultant for Johnson & Johnson, Eli Lilly, Sanofi, Novo Nordisk, Roche Diagnostics, Dexcom, AstraZeneca, and Boehringer Ingelheim.

Figures

Figure 1.

Flow chart of recruitment.

Figure 2.

Percentage of eligible/approached patients who agreed versus declined according to month of decision. Black bars = agree; gray bars = decline. Patients were significantly more likely to agree in fall/winter months (October-March) than in spring/summer months (April-September) (P < .0001).

Figure 3.

Number of months between date of initial approach and date of decision for thinkers. Black bars = delayed agree; gray bars = delayed decline. Among thinkers, patients who made a decision within 2 weeks of initial approach were more likely to agree (P < .0001) and required fewer follow-up contacts (P < .0001) than patients who made a decision after 2 weeks.