Background: Complications arising from uncontrolled type 2 diabetes mellitus (T2DM) pose a significant burden on individuals' wellbeing and healthcare resources. Digital interventions may play a key role in mitigating such complications by supporting patients to adequately self-manage their condition.
Aim: To assess the impact of DiabeText, a new theory-based, patient-centred, mobile health intervention integrated with electronic health records to send tailored short text messages to support T2DM self-management.
Design and setting: A pragmatic, phase-three, 12-month, two-arm randomised clinical trial involving primary care patients with T2DM in the Balearic Islands, Spain, including in urban and rural areas.
Method: In total, 742 participants with suboptimal glycaemic control (glycated haemoglobin [HbA1c] level >7.5) were randomly allocated to a control (usual care) or intervention (DiabeText) group. In addition to usual care, the DiabeText group received 167 messages focused on healthy lifestyle and medication adherence. The primary outcome was HbA1c level. Secondary outcomes were: medication possession ratio; health-related quality of life (measured using the EQ-5D-5L questionnaire); diabetes self-efficacy (measured using the Diabetes Self-Efficacy Scale [DSES]); and self-reported adherence to medication, Mediterranean diet (measured using the 14-Item Mediterranean Diet Adherence Screener [MEDAS-14]), and physical activity (measured using the International Physical Activity Questionnaire [IPAQ]).
Results: Over the 12-month period, no statistically significant differences in HbA1c were observed between the intervention and the control groups (β = -0.025 [95% confidence interval {CI} = -0.198 to 0.147; P = 0.772]). In comparison with the control group, the DiabeText group showed significant (P<0.05) improvements in self-reported medication adherence (odds ratio = 1.4; 95% CI = 1.0 to 1.9), DSES (Cohen's d = 0.35), and EQ-5D-5L (Cohen's d = 0.18) scores, but not for the rest of the secondary outcomes.
Conclusion: DiabeText successfully improved quality of life, diabetes self-management, and self-reported medication adherence in primary care patients with T2DM. Further research is needed to enhance its effects on physiological outcomes.
Keywords: glycaemic control; medication adherence; primary care; quality of life; telemedicine; type 2 diabetes mellitus.
© The Authors.