Feasibility, Acceptability, and Preliminary Efficacy of an Intensive Clinic-Based Intervention for Children With Poorly Controlled Type 1 Diabetes.

ABSTRACT

OBJECTIVE: To evaluate the feasibility, acceptability, and preliminary efficacy of a team-based intervention for youth with type 1 diabetes (T1D) with suboptimal glycemia, as detected based on the measurement of hemoglobin A1C (HbA1C). METHODS: Forty participants with T1D for >1 year and an HbA1C level of ≥9.5% (80 mmol/mol) enrolled for a multidisciplinary intervention that included pediatric endocrinologists, pediatric psychologists, and a certified diabetes care and education specialist (CDCES). The CDCES-integrated medical management, while reinforcing physical, emotional, and behavioral health, connected with families to set and monitor goals and reviewed medication adjustments. The feasibility was assessed based on enrollment targets; acceptability based on retention rates; and preliminary efficacy based on changes in HbA1C levels, quality of life, diabetes-related strengths and resilience, hospital admissions, emergency room visits, and missed school days. RESULTS: Of 43 patients and families approached, 40 agreed to participate, 36 completed the 4-month intervention, and 31 completed full 8 months of follow-up data collection. The CDCES coach averaged 6.8 contacts per participant during the 8-month study period. The HbA1C level reduced significantly from baseline to 4 months (12.1% ± 1.6% to 11.0% ± 1.9%, P = .001) and was sustained at 8 months (10.7% ± 1.9%, P < .001). The participants reported significant increases in diabetes-specific quality of life (P < .05) and diabetes-related strength and resilience (P = .003). The missed school days reduced from 7.23 ± 7.5 days to 1.55 ± 1.9 days (P < .001), and the diabetes-related hospitalizations decreased from 0.4 ± 0.6 to 0.1 ± 0.3 (P = .009). CONCLUSION: Preliminary data suggest that a multidisciplinary intervention leveraging a team-based approach with a physician, psychologist, and CDCES can support improvements in glycemic control and psychosocial outcomes among youth with T1D with an HbA1C level above the target.