Impact of an SMS intervention to support type 2 diabetes self-management: DiabeText clinical trial.

Background: Complications arising from uncontrolled Type 2 Diabetes Mellitus (T2DM) pose a significant burden on individuals' well-being 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-centered, mobile health intervention integrated with electronic health records to send tailored short text messages to support T2DM self-management.

Design and setting: Pragmatic, Phase III, 12-month, two-arm randomized clinical trial with T2DM primary care patients in Spain.

Method: 742 participants with suboptimal glycemic control (HbA1c>7.5) were randomly allocated to a control (usual care) or intervention (DiabeText) group. The DiabeText group received, in addition to usual care, 165 messages focused on healthy lifestyle and medication adherence.

Primary outcome: glycated hemoglobin (HbA1c).

Secondary outcomes: medication possession ratio, quality of life (EQ-5D-5L), diabetes self-efficacy (DSES); and self-reported adherence to medication, Mediterranean diet (MEDAS-14), and physical activity (IPAQ).

Results: Over the 12-month period, we observed no significant differences in HbA1c between the intervention and the control groups (Beta=-0.025 (-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 (OR=1.4; 95%CI: 1.0 to 1.9), DSES (Cohen's d=0.35), and EQ5D-5L (Cohen's d=0.18) scores; but not in the rest of 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.