No Effect of an Automated Bolus Calculator in Pediatric Patients with Type 1 Diabetes on Multiple Daily Injections: The Expert Kids Study

Abstract

Background: This multicenter crossover study investigated the potential beneficial effect of an automated bolus calculator (ABC) in children and adolescents with type 1 diabetes (T1D) treated with multiple daily injections (MDI). Methods: Participants were randomized to either begin or end with a 5 months intervention versus their regular treatment regimen (control), separated by a 2 months washout period. During the intervention participants were carefully instructed to use the ABC (Accu-Check Aviva Expert) versus manual insulin calculations during the control period. Participants between 8 and 18 years of age with T1D were recruited from clinics in Denmark, Belgium, and Spain. Inclusion criteria included T1D for >1 year, a minimum of 3 months MDI treatment before inclusion, and HbA1c of 7.5%-11% (57-97 mmol/mol). Improvement in HbA1c was the main outcome, and improved quality of life (QoL) and glucose variability (time spent in target glucose) were secondary outcomes. Results: A total of 65 patients with a mean age of 13.25 years and a mean HbA1c of 8.25% (66.7 mmol/mol) were included. Midway evaluation after 2 months of intervention showed no significant difference from the standard care (0.297, 95% confidence interval [CI]:-0.645 to 0.054; P = 0.10). The difference remained insignificant after the 5 months of intervention (-0.143 [95% CI:-0.558 to 0.272; P = 0.51]). Using the ABC did not change the time spent in target glucose range, nor did it change the QoL. Conclusions: Our study did not demonstrate beneficial additive effects of an ABC in children and adolescents with T1D treated with MDI neither in HbA1c, nor in any other endpoint investigated.

Clinical Evaluation of a Novel CGM-Informed Bolus Calculator with Automatic Glucose Trend Adjustment

“…In the past, it has been suggested that bolus calculator use could improve outcomes when used consistently by people with T1D, 14 , 15 but a recent well-designed 10-month randomized crossover study using an automated bolus calculator device failed to show improvements in HbA1c or quality of life. 16 Although this study was conducted using a simpler bolus calculator based on static BG readings for multiple daily injection users, the requirement for the user to enter insulin doses and BG readings manually for correct usage likely affected outcomes. When designing new diabetes technology or treatment methods, it is important to consider the ease of use and burden placed on the user for correct use, which will influence the success of the treatment.…”