Gomes Rodrigues Daniela Laranja, Belber Gisele Silvestre, Valle de Queiroz Padilha Frederica, Bassolli de Oliveira Alves Lucas, Avezum Álvaro, Maeyama Marcos Aurélio, Vitti Alexsandra, Pompermaier Greta Barriquel, Damas Tanise Balvedi, Selbach Otero Mariana Selbach, Souza de Aguiar Raquel, Almeida de Andrade Renata, Spinel Ligia Fonseca, Neves Marques Pinho Ana Paula, de Oliveira Junior Haliton Alves
Social Responsibility, Hospital Alemão Oswaldo Cruz, São Paulo, Brazil.
International Research Center, Hospital Alemão Oswaldo Cruz, São Paulo, Brazil.
Lancet Reg Health Am. 2024 Oct 23;39:100923. doi: 10.1016/j.lana.2024.100923. eCollection 2024 Nov.
This study addresses the rising burden of type 2 diabetes mellitus, and explores the potential of teleconsultation, as an alternative for diabetes management. The primary objective was to test the hypothesis that teleconsultation is non-inferior to face-to-face consultation in terms of glycaemic control measured as glycated haemoglobin (HbA1c) (non-inferiority margin for the upper confidence interval for the difference between groups of 0,5% in HbA1c) for type 2 diabetes mellitus patients referred from Primary Healthcare to Specialized Care within the SUS.
TELECONSULTA, is a randomized, pragmatic, phase 2, single-centre, open-label, non-inferiority trial conducted in Joinville, Brazil. A total of 278 participants diagnosed with type 2 diabetes were randomized through mandatory teleconsulting services from primary care health units. The randomization was 1:1 to teleconsultation or face to face consultation. The study was registered at the Brazilian Clinical Trial Register-REBEC, under the code RBR-8gpgyd. Study status is "Completed".
This study included 278 participants in the intention-to-treat (ITT) analysis. The median age was 61 (54-68) years, 167 (60%) were women. The between-groups comparative average reduction in HbA1c was -0.6% (90% CI -1.0; -0.1) at 3-months and -0.5% (90% CI -0.9; 0.0) at 6-months in Modified Intention-to-Treat (mITT) population with imputed data, showing the non-inferiority of teleconsultation. Results with no missing data imputation and in the per protocol population were similar. The frequency of hypoglycaemia and other adverse events was well balanced between groups.
The results underscore the transformative potential of telemedicine in addressing the complexities of diabetes management within the framework of a universal healthcare system, contributing with valuable insights for healthcare policymakers and practitioners seeking innovative solutions to tackle the growing diabetes epidemic.
This study was funded by the Brazilian Ministry of Health, through the Unified Health System-Institutional Development Support Program (PROADI-SUS).
本研究旨在应对2型糖尿病日益加重的负担，并探索远程会诊作为糖尿病管理替代方案的潜力。主要目标是检验以下假设：对于通过单一卫生系统（SUS）从初级医疗转诊至专科护理的2型糖尿病患者，就糖化血红蛋白（HbA1c）测量的血糖控制而言，远程会诊不劣于面对面会诊（组间差异的上置信区间的非劣效界值为HbA1c的0.5%）。
TELECONSULTA是一项在巴西茹安维尔进行的随机、实用、2期、单中心、开放标签、非劣效性试验。共有278名被诊断为2型糖尿病的参与者通过初级保健卫生单位的强制性远程会诊服务进行随机分组。随机比例为1:1，分为远程会诊组或面对面会诊组。该研究已在巴西临床试验注册中心-REBEC注册，注册号为RBR-8gpgyd。研究状态为“已完成”。
本研究纳入了278名参与者进行意向性分析（ITT）。中位年龄为61（54-68）岁，167名（60%）为女性。在采用插补数据的改良意向性分析（mITT）人群中，3个月时组间HbA1c平均降低值为-0.6%（90%CI -1.0；-0.1），6个月时为-0.5%（90%CI -0.9；0.0），表明远程会诊不劣于面对面会诊。无缺失数据插补时以及符合方案人群中的结果相似。低血糖和其他不良事件的发生率在两组间分布均衡。
研究结果强调了远程医疗在全民医疗体系框架内应对糖尿病管理复杂性方面的变革潜力，为寻求创新解决方案以应对日益严重的糖尿病流行问题的医疗政策制定者和从业者提供了有价值见解。
本研究由巴西卫生部通过统一卫生系统-机构发展支持计划（PROADI-SUS）资助。
