Background: Lifestyle is important in the treatment of type 2 diabetes. The aim of this study was to investigate whether a lifestyle programme through a smartphone application (digital therapeutic) could affect treatment outcomes at an endocrinology outpatient clinic.
Methods: In this randomised controlled study, patients were consecutively invited to participate. Participants were randomly assigned to an intervention group or a control group. In addition to standard care, intervention group participants used a smartphone application that gave access to the lifestyle programme, through which they received personalized recommendations and clinical-guideline-compliant education about healthy lifestyle. Both groups visited the clinic every other month for six months for follow-up measurements, including body weight and blood tests for glycated haemoglobin (HbA1c) and blood lipids. Furthermore, all participants filled in questionnaires about distress related to diabetes, health-related quality of life, depression and anxiety. Statistical methods included parametric and nonparametric tests for comparisons both within and between groups.
Results: A total of 37 patients (23 women) were included, whereof 30 finished, 15 in each group (19% dropout), average age 52.7 ± 10.6 (2570) years. No significant differences emerged between the groups, but within the intervention group there was a significant decrease in HbA1c, from 61 ±21.4 to 52.7 ±15.2 mmol/mol. Furthermore, the intervention group saw a decrease in disease-specific distress (Problem Areas In Diabetes Scale from 19.5 ±16.5 to 11.7 ±13.4) and anxiety symptoms (from 5.4 ±4.0 to 4.1 ±3.8). No significant changes occurred in the control group over the six-month research period. Usage of the app in the intervention group was most frequent during the first months and differed interpersonally.
Conclusions: Our results indicate that a digital lifestyle programme could enhance outpatient treatment outcomes in type 2 diabetes, in terms of both glycaemic control and psychological health.