Intensive remote monitoring versus conventional care in type 1 diabetes: A randomized controlled trial.

Objective: While frequent contact with diabetes care providers may improve glycemic control among patients with type 1 diabetes (T1D), in-person visits are labor-intensive and costly. This study was conducted to assess the impact of an intensive remote therapy (IRT) intervention for pediatric patients with T1D.

Methods: Pediatric patients with T1D were randomized to IRT or conventional care (CC) for 6 months. Both cohorts continued routine quarterly clinic visits and uploaded device data; for the IRT cohort, data were reviewed and patients were contacted if regimen adjustments were indicated. Glycated hemoglobin (HbA1c) change from baseline was assessed at 6 and 9 months. Diabetes-related quality of life (QoL), healthcare services utilization, and hypoglycemic events were also tracked.

Results: Among 117 enrollees (60 IRT, 57 CC), mean (SD) 6-month %HbA1c change for IRT vs CC was -0.34 (0.85) (-3.7 mmol/mol) vs -0.05 (0.74) (-0.5 mmol/mol) overall (P = .071); -0.15 (0.67) (1.6 mmol/mol) vs -0.02 (0.66) (0.2 mmol/mol) for ages 8 to 12 (P = .541); and -0.50 (0.95) (-5.5 mmol/mol) vs -0.06 (0.80) (-0.7 mmol/mol) for ages 13 to 17 (P = .056). Diabetes-related QoL increased by 6.5 and 1.3 points for IRT and CC, respectively (P = .062). Three months after intervention cessation, %HbA1c changed minimally among treated children aged 8 to 12 but increased by 0.22 (0.89) (2.4 mmol/mol) among those aged 13 to 17.

Conclusions: IRT substantially affected diabetes metrics and improved QoL among pediatric patients with T1D. Adolescents experienced a stronger treatment effect, but had difficulty in sustaining improved control after intervention cessation.