Effectiveness of diabetes self-management education via a smartphone application in insulin treated type 2 diabetes patients - Design of a randomised controlled trial ('TRIGGER study')

Background: Health care providers aim to stimulate self-management in type 2 diabetes (T2DM) patients. However, they have a limited number of patient contacts to do this. With the growing number of T2DM patients, innovative and cost-effective interventions to promote self-management are needed. We aim to evaluate the effectiveness of diabetes self-management education via a smartphone app in T2DM patients on insulin therapy. Methods: Non-blinded two-arm multi-centre randomised controlled superiority trial with parallel-groups and equal randomisation ('TRIGGER study'). Eligible patients are 40-70 years, on insulin therapy since at least 3 months, with HbA1c > 53 mmol/mol (> 7%). In total 228 patients will be recruited. The intervention group (n = 114) will receive diabetes self-management education via a smartphone app to trigger diabetes self-management: unidirectional text messages, free of charge, evidence and psychological theory based, with regard to dietary habits, physical activity, hypoglycaemia and glucose variability. Patients choose their preferred frequency (two to six times per week), topics (two or three additionally to hypoglycaemia, which is an obligatory topic), and duration (6 or 9 months). The control group (n = 114) will receive care-as-usual. The primary study endpoint is the HbA1c level after a follow-up of 6 months. The percentage of patients who achieve an HbA1c level ≤ 53 mmol/mol (≤7%) without hypoglycaemia (plasma glucose < 3.5 mmol/L (< 63 mg/dL)) is a co-primary outcome. Secondary outcomes are body mass index, waist circumference, insulin dose, lipid profile, blood pressure, number of hypoglycaemic events, glycaemic variability, self-management (SDSCA), food habits (FFQ), physical activity (IPAQ), health status (EQ-5D-5 L, SF36), diabetes-dependent quality of life (ADDQoL), diabetes treatment satisfaction (DTSQ), satisfaction with the app, the cost-effectiveness of the intervention after 3 months, and sustainability of the intervention effect (3 months extra follow-up in intervention group to compare prolonged to discontinued use of the app). We will use the intention-to-treat principle to analyse data. Discussion: Innovative solutions are needed to improve the (cost-) effectiveness of self-management for the increasing number of T2DM patients. This trial will provide evidence on the effectiveness of a newly developed smartphone app, designed to trigger diabetes self-management. Trial registration: Dutch Trial Register NTR5515, registration date: 18 November 2015 (prospectively registered)