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 2 weeks after being approached agreed to participate (P