The Beneficial Effect of the Mobile Application in Children and Adolescents with Type 1 Diabetes Mellitus: A Randomized Controlled Trial.

is a mobile application which we developed for children and adolescents suffering type 1 diabetes mellitus (T1DM) for calculation of the appropriate insulin bolus dose by importing in the equation carbohydrates, lipids, glucose levels, and personalized parameters. Aim of this study is to evaluate the efficacy of this application on patients' glycemic control and satisfaction. Eighty children and adolescents (aged 13.5 ± 2.8 years old, mean ± standard deviation) with T1DM were included in the study and were randomly and equally assigned in two groups. Patients were asked to use for the calculation of the bolus insulin dose in the E group and to pursue their routine calculations in the C group (controls). At baseline and at 3, 6, and 12 months following the initial visit, glycated hemoglobin (HbA1c) values, percentages of hypoglycemias, hyperglycemias, and normoglycemias were determined for each patient, while Diabetes Treatment Satisfaction Questionnaire (DTSQ) was used to assess patients' treatment satisfaction at baseline and at 6 and 12 months. Children and adolescents in the E group had a statistically significant decrease in HbA1c values and increase in percentages of normoglycemias and DTSQ scores, in comparison to children and adolescents in the C group. In the E group, a statistically significant positive linear correlation was found between DTSQ score and percentages of normoglycemias and a statistically significant negative correlation between changes in percentages of normoglycemias (Δnormoglycemias) and changes in HbA1c (ΔHbA1c). The use of the mobile application contributes to the improvement of glycemic control and treatment satisfaction of children and adolescents with T1DM.