Effect of an Intensive, Integrated Telehealth Intervention on Glycemic Control in Children and Adolescents With Type 1 Diabetes Using Continuous Glucose Monitoring: A Randomized, Crossover Trial.

Abstract

Aim: To examine the impact of adding an intensive, integrated telehealth intervention on glycemic control in children and adolescents with type 1 diabetes using continuous glucose monitoring (CGM) and multiple daily injections (MDIs) of insulin. Materials and Methods: In this randomized, two-period crossover trial conducted between May 2023 and June 2024, 105 children and adolescents with type 1 diabetes using FreeStyle Libre 2 CGM were randomized to receive intensive telehealth weekly over 12 weeks first followed by routine care (n = 50) or routine care over 12 weeks first followed by intensive telehealth weekly (n = 55), with a 2-week washout. Intensive telehealth was intensified follow-up with weekly teleconsultation (20 min, by telephone) and digital support from a trained diabetes educator delivering structured support, including review of the latest ambulatory glucose profile. The primary outcome measures were HbA1c and GCM metrics. Results: The average (SD) age of the study cohort (n = 105) was 11.8 (4.2) years, 48.6% were female, with an average diabetes duration of 3.5 (3.0) years and suboptimally controlled diabetes in terms of HbA1c levels (9.4 (1.6) %, target < 6.5%), and other 14-day CGM metrics. Compared with routine care, intensified follow-up with weekly intensive telehealth was associated with a decrease in HbA1c (-0.29 (0.60) %, 95%CIs -0.41 to -0.17, p  < 0.001), significantly increased time in range (TIR), and decreased time above range (TAR), average glucose level, glucose variability, glucose management indicator (GMI), and frequency of low glucose events. Teleconsultation did not affect time below range (TBR), which was already within target. Conclusion: This randomized, controlled, and crossover study shows that intensified follow-up with a weekly telehealth intervention results in small but significant improvements in glycemic control metrics in children and adolescents. The clinical impact of these changes requires prospective study.