Smartphone triggered diabetes self-management education and support in insulin treated type 2 diabetes patients: results of the randomised TRIGGER study

Background and aims: Innovative and cost-effective interventions to promote diabetes self-management education and support (DSME/S) are needed. We evaluated the (cost-)effectiveness of DSME/S delivered via a smartphone application in individuals with type 2 diabetes mellitus (T2DM) on insulin therapy. Materials and methods: We conducted a non-blinded two-arm multi-centre randomised clinical superiority trial with parallel-groups and equal randomisation (1:1). In total, 5 hospitals and 66 general practices in the Netherlands included 230 individuals with T2DM aged 40-70 years, on insulin therapy since ≥3 months, with HbA1c >53 mmol/mol (>7%). The intervention group received unidirectional messages with DSME/S on dietary habits, physical activity, hypoglycaemia prevention and glucose variability. Messages were sent at different times of the day, 2 or 6 times per week for 6 to 9 months. Participants could choose their preferred topics, frequency and the duration of the intervention. The control group received usual care. The primary study endpoint was the HbA1c level after 6 months follow-up. Secondary endpoints were body mass index, waist circumference, blood pressure, insulin dose, lipid profile, self-management (assessed with Summary of Diabetes Self-Care Activities), health status (assessed with EQ-5D), diabetes-dependent quality of life (assessed with Audit of Diabetes Dependent Quality of Life), and diabetes treatment satisfaction (assessed with Diabetes Treatment Satisfaction Questionnaire). Here we present the results of the complete case analyses of the first 150 participants who completed the study. At the EASD conference we will be in the position to present the final results of all 230 participants. We used the intention-to-treat principle and general linear models, adjusted for baseline value, baseline insulin dose, age, sex, and duration of diabetes to analyse the data. Results: There were no differences in baseline characteristics between the control and intervention group: mean age was 58.6 years (intervention group) versus 59.8 years (control group), and the baseline HbA1c was 64.7 mmol/mol (intervention group) versus 66.5 mmol/mol (control group). After 6 months of follow-up, the mean HbA1c in the intervention group was 61.7 mmol/mol (95% CI 58.9 - 64.5), compared to 65.7 mmol/mol (95% confidence interval (CI) 62.9 - 68.6) in the control group, p = 0.051 (n = 150). After adjustment, the mean HbA1c levels became 63.1 mmol/mol (95% CI 61.0 - 65.2) in the intervention group, versus 64.9 mmol/mol (95% CI 62.8 - 67.0) in the control group, p = 0.230 (n = 139). After 6 months, the mean number of days on which participants performed foot care was higher in the control group, adjusted: 1.3 days (95% CI 0.9 - 1.7) in the intervention group versus 1.9 days (1.5 - 2.3) in the control group, p = 0.027 (n = 125). There were no statistically significant effects on other secondary outcomes. Conclusion: The preliminary results of this trial, which is one of the larger ones in this field worldwide, show modestly promising, yet inconclusive results on the effectiveness of smartphone triggered diabetes self-management education and support in insulin treated T2DM patients. Analyses of all cases will provide final evidence on its effectiveness.