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Recruitment Into a Pediatric Continuous Glucose Monitoring RCT
Lisa K Volkening1, Kaitlin C Gaffney1, Michelle L Katz1
11 Section on Clinical, Behavioral & Outcomes Research, Pediatric, Adolescent, and Young Adult Section, Joslin Diabetes Center, Boston, MA, USA.
Insights
Recruiting youth with type 1 diabetes for continuous glucose monitoring (CGM) trials is challenging. Younger patients, shorter diabetes duration, and quicker decisions improve participation in these vital diabetes technology studies.
Area of Science:
- Pediatric Endocrinology
- Clinical Trial Recruitment
- Diabetes Technology Research
Background:
- Recruitment for clinical trials, particularly those involving advanced technologies like continuous glucose monitoring (CGM), presents significant challenges.
- Pediatric studies, such as those for type 1 diabetes, face unique hurdles due to potential reluctance from adolescent participants regarding device use.
Purpose of the Study:
- To identify key patient and family characteristics influencing participation in a continuous glucose monitoring (CGM) randomized controlled trial (RCT).
- To understand recruitment process factors associated with decisions to join a 2-year CGM RCT for youth with type 1 diabetes.
Main Methods:
- Eligible patients were approached by study staff, with families categorized by participation decision (agree/decline) and decision timing (immediate vs. delayed).
- Data were collected over 18 months on patient demographics, diabetes management, and recruitment outcomes.
Main Results:
- Younger patients with shorter diabetes duration, lower insulin doses, more frequent blood glucose monitoring, and use of insulin pump therapy were more likely to agree to participate.
- Families were more likely to agree to participation during fall/winter compared to spring/summer.
- A significant factor for nonparticipation was a lack of interest in CGM; delayed decisions (>2 weeks) also reduced participation likelihood.
Conclusions:
- Understanding patient/family characteristics and decision-making timelines is crucial for optimizing recruitment strategies in pediatric CGM trials.
- These findings can inform future recruitment efforts for studies on advanced diabetes technologies in youth.
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.
