An Intervention by a Patient-Designed Do-It-Yourself Mobile Device App Reduces HbA1c in Children and Adolescents with Type 1 Diabetes: A Randomized Double-Crossover Study

Abstract

Background:

Prevention of type 1 diabetes mellitus (T1DM)-related complications is dependent on metabolic control. The recommended glycated hemoglobin (HbA1c) values <7.5% (58.5 mmol/mol) are met only by a minority of diabetic children and especially adolescents. The aim of this study was to evaluate the impact of an intervention comprising the use of Webdia, a patient-designed app for smartphones, on metabolic control of T1DM in children.

Methods:

Fifty-five patients with T1DM, 10–18 years of age, were included in this single-center, randomized double-crossover study. We tested an intervention consisting of using Webdia for 3 months with monthly feedback and adaptation of the treatment. Main outcome was modification of HbA1c. Secondary outcomes were the prevalence of hypoglycemia and quality of life (QoL).

Results:

Of the 55 included patients, 33 completed the study, 9 dropped out, and 13 were excluded due to insufficient use of the app. The app was well accepted by the users who completed the study (46.4% rated the program as good and 39.3% as excellent). The intervention led to a reduction of HbA1c by 0.33%, compared to the control group in which HbA1c rose by 0.21% (P = 0.048) in patients with HbA1c values >8.0% (63.9 mmol/mol) at inclusion, without increasing the prevalence of hypoglycemia (8.52 ± 9.45 hypoglycemic events during last 2 weeks of intervention vs. 7.62 ± 6.37 observation, P = 0.680). QoL scores were not modified.

Conclusions:

The intervention resulted in a significant decrease in HbA1c, without increasing the prevalence of hypoglycemia in patients with initial HbA1c >8.0% (63.9 mmol/mol).