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.

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).