Effectiveness of DiabeText, a mHealth intervention to support diabetes self-management: randomized controlled trial in primary care

Background Complications arising from uncontrolled Type 2 Diabetes (T2D) poses 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 T2D self-management. Design and setting Pragmatic, phase III, 12-month, two-arm randomized clinical trial with T2D 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 At 12 months follow-up, no statistically significant differences in mean HbA1c were observed between the intervention (7.5 [95%CI 6.7 to 8.2]) and control groups (7.4 [6.7 to 8.3]). 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=0.4), and EQ5D-5L (Cohen’s d=0.2) 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 T2D. Further research is needed to enhance its effects on physiological outcomes. ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial NCT05006872 ### Clinical Protocols ### Funding Statement This research is funded by Ministerio de Ciencia, Innovacion y Universidades and co-funded by European Regional Development Fund, grant number RTI2018-096935-A-I00. I.R.-C. is funded by Instituto de Salud Carlos III, grant number CP17/00017. R.Z.-C. is funded by Ministerio de Ciencia, Innovacion y Universidades. M.J.S.-R. and M.A.F.-d. are funded by Instituto de Investigacion Sanitaria de las Islas Baleares, grant number FOLIUM17/10 (co-funded by ITS-2017 and PO FSE 2014-2020) and FOLIUM19/05 (founded by ITS-2019-003), respectively. J.K. is granted with Juan de la Cierva-Incorporacion contract (IJC2019-042420-I/AEI/10.13039/501100011033) from Agencia Estatal de Investigacion. The rest of the authors are not funded by any grant or award to develop this work. The funders had no role in study design nor preparation of the protocol. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The study follows the Declaration of Helsinki ethical standards and all the procedures were approved by the Institutional Review Board of the Balearic Islands Health Service Research Ethics (CEI-IB Ref No: IB4320/20PI). I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors