Zamanillo-Campos Rocío, Fiol-deRoque María Antonia, Serrano-Ripoll María Jesús, Llobera-Canaves Joan, Taltavull-Aparicio Joana María, Leiva-Rus Alfonso, Ripoll-Amengual Joana, Angullo-Martínez Escarlata, Socias-Buades Isabel María, Masmiquel-Comas Lluís, Konieczna Jadwiga, Zaforteza-Dezcallar María, Boronat-Moreiro María Asunción, Mira-Martínez Sofía, Gervilla-García Elena, Ricci-Cabello Ignacio
Research Group on Primary Care and Promotion of the Balearic Islands Community (Grapp-CAIB), Health Research Institute of the Balearic Islands (IdISBa), Palma, and Primary Care Research Unit of Mallorca, Balearic Islands Health Service, Palma.
Research Group on Primary Care and Promotion of the Balearic Islands Community (Grapp-CAIB), Health Research Institute of the Balearic Islands (IdISBa), Palma, and RICAPPS - Red de Investigación Cooperativa de Atención Primaria y Promoción de la Salud, Carlos III Health Institute (ISCIII), Madrid.
Br J Gen Pract. 2025 Jan 13. doi: 10.3399/BJGP.2024.0206.
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.
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.
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.
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]).
Over the 12-month period, no statistically significant differences in HbA1c were observed between the intervention and the control groups (ß = -0.025 [95% confidence interval {CI} = -0.198 to 0.147; = 0.772]). In comparison with the control group, the DiabeText group showed significant (<0.05) improvements in self-reported medication adherence (odds ratio = 1.4; 95% CI = 1.0 to 1.9), DSES (Cohen's = 0.35), and EQ-5D-5L (Cohen's = 0.18) scores, but not for the rest of the 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.
2型糖尿病（T2DM）控制不佳引发的并发症给个人健康和医疗资源带来了沉重负担。数字干预可能通过支持患者充分自我管理病情，在减轻此类并发症方面发挥关键作用。
评估DiabeText的影响，DiabeText是一种基于新理论、以患者为中心的移动健康干预措施，与电子健康记录相结合，发送量身定制的短信息以支持T2DM自我管理。
一项务实的、三期、为期12个月的双臂随机临床试验，涉及西班牙巴利阿里群岛的初级保健T2DM患者，包括城市和农村地区。
总共742名血糖控制不佳（糖化血红蛋白[HbA1c]水平>7.5）的参与者被随机分配到对照组（常规护理）或干预组（DiabeText）。除常规护理外，DiabeText组收到了167条关注健康生活方式和药物依从性的信息。主要结局是HbA1c水平。次要结局包括：药物持有率；健康相关生活质量（使用EQ-5D-5L问卷测量）；糖尿病自我效能感（使用糖尿病自我效能量表[DSES]测量）；以及自我报告的药物依从性、地中海饮食（使用14项地中海饮食依从性筛查量表[MEDAS-14]测量）和身体活动（使用国际身体活动问卷[IPAQ]测量）。
在12个月期间，干预组和对照组之间未观察到HbA1c有统计学显著差异（β=-0.025[95%置信区间{CI}=-0.198至0.147；P=0.772]）。与对照组相比，DiabeText组在自我报告的药物依从性（比值比=1.4；95%CI=1.0至1.9）、DSES（科恩d=0.35）和EQ-5D-5L（科恩d=0.18）评分方面有显著（P<0.05）改善，但其他次要结局未改善。
DiabeText成功改善了初级保健T2DM患者的生活质量、糖尿病自我管理和自我报告的药物依从性。需要进一步研究以增强其对生理结局的影响。
