Giovanazzi Alexia, Gios Lorenzo, Gentilini Maria Adalgisa, Mastellaro Marina, Bartolotta Patrizia, Nicolussi Giacomaz Lucrezia, Eccher Claudio, Inchiostro Sandro
Servizio Governance Clinica, Azienda Provinciale per i Servizi Sanitari della Provincia Autonoma di Trento, Trento, Italy.
TrentinoSalute4.0, Competence Center for Digital Health, Trento, Provincia Autonoma di Trento, Italy.
Front Clin Diabetes Healthc. 2025 Jun 10;6:1589548. doi: 10.3389/fcdhc.2025.1589548. eCollection 2025.
BACKGROUND: The use of technologies in the health field has progressively increased. Within the context of a broader project funded by the Italian Ministry of Health (TELEMECHRON study), a randomised controlled trial (RCT) has been conducted in the Autonomous Province of Trento on type 2 diabetes individuals with an untargeted glycated haemoglobin (HbA1c) level. METHODS: The overall aim was to evaluate the impact of the "TreC Diabete" digital platform, including a smartphone application (app) and a dashboard. This open-label, parallel-group, 1:1 allocation ratio RCT in which the intervention group used the app for data entry, symptoms questionnaire, communication with healthcare staff and medication recording, while the control group received standard care. The primary endpoint was change in HbA1c levels at 12 months between groups. RESULTS: Between December 2022 and August 2023, 103 participants were enrolled (51 intervention; 52 control), with a median age of 67 years old, time from diabetes diagnosis to enrolment 13 years, and 72% male. At 12 months, the median change in HbA1c levels did not differ significantly between groups. Regarding app usage, data entries decreased significantly from the first quarter to the second quarter but subsequently stabilised (p = 0.001). System usability (from 42 responders in the intervention group) had a median score of 95 (range: 0-100), indicating a high level of satisfaction with the platform. DISCUSSION: The study faced several challenges, including platform technical issues, service interruption, data entry anomalies and difficulties in participant recruitment. Study generalisability may be limited by the sample's demographics, as the trial predominantly included younger male individuals with a specific HbA1c level. CONCLUSION: The study highlighted key factors for future implementations, including understanding technology benefits, addressing adoption barriers, and providing education and support to both patients and healthcare providers.
背景:技术在健康领域的应用日益广泛。在意大利卫生部资助的一个更广泛项目(TELEMECHRON研究)背景下,在特伦托自治省对糖化血红蛋白(HbA1c)水平未达标的2型糖尿病患者开展了一项随机对照试验(RCT)。 方法:总体目标是评估“TreC Diabete”数字平台的影响,该平台包括一款智能手机应用程序(应用)和一个仪表盘。这是一项开放标签、平行组、1:1分配比例的RCT,干预组使用该应用进行数据录入、症状问卷填写、与医护人员沟通以及用药记录,而对照组接受标准护理。主要终点是两组在12个月时HbA1c水平的变化。 结果:2022年12月至2023年8月期间,共招募了103名参与者(51名干预组;52名对照组),中位年龄为67岁,从糖尿病诊断到入组的时间为13年,男性占72%。在12个月时,两组之间HbA1c水平的中位变化无显著差异。关于应用的使用情况,数据录入从第一季度到第二季度显著减少,但随后趋于稳定(p = 0.001)。系统可用性(来自干预组的42名应答者)的中位得分为95分(范围:0 - 100),表明对该平台的满意度较高。 讨论:该研究面临多项挑战,包括平台技术问题、服务中断、数据录入异常以及参与者招募困难。由于试验主要纳入了具有特定HbA1c水平的年轻男性个体,研究的普遍性可能受到样本人口统计学特征的限制。 结论:该研究突出了未来实施的关键因素,包括了解技术益处、解决采用障碍以及为患者和医护人员提供教育与支持。
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