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. 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. Pragmatic, Phase III, 12-month, two-arm randomized clinical trial with T2DM primary care patients in Spain. 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. glycated hemoglobin (HbA1c). 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). 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. 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.
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