Teleconsultation on patients with type 2 diabetes in the Brazilian public health system: a randomised, pragmatic, open-label, phase 2, non-inferiority trial (TELECONSULTA diabetes trial)

IF 7 Q1 HEALTH CARE SCIENCES & SERVICES

Lancet Regional Health-Americas Pub Date : 2024-10-23 DOI:10.1016/j.lana.2024.100923

Daniela Laranja Gomes Rodrigues , Gisele Silvestre Belber , Frederica Valle de Queiroz Padilha , Lucas Bassolli de Oliveira Alves , Álvaro Avezum , Marcos Aurélio Maeyama , Alexsandra Vitti , Greta Barriquel Pompermaier , Tanise Balvedi Damas , Mariana Selbach Selbach Otero , Raquel Souza de Aguiar , Renata Almeida de Andrade , Ligia Fonseca Spinel , Ana Paula Neves Marques Pinho , Haliton Alves de Oliveira Junior

{"title":"Teleconsultation on patients with type 2 diabetes in the Brazilian public health system: a randomised, pragmatic, open-label, phase 2, non-inferiority trial (TELECONSULTA diabetes trial)","authors":"Daniela Laranja Gomes Rodrigues , Gisele Silvestre Belber , Frederica Valle de Queiroz Padilha , Lucas Bassolli de Oliveira Alves , Álvaro Avezum , Marcos Aurélio Maeyama , Alexsandra Vitti , Greta Barriquel Pompermaier , Tanise Balvedi Damas , Mariana Selbach Selbach Otero , Raquel Souza de Aguiar , Renata Almeida de Andrade , Ligia Fonseca Spinel , Ana Paula Neves Marques Pinho , Haliton Alves de Oliveira Junior","doi":"10.1016/j.lana.2024.100923","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>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.</div></div><div><h3>Methods</h3><div>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”.</div></div><div><h3>Findings</h3><div>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.</div></div><div><h3>Interpretation</h3><div>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.</div></div><div><h3>Funding</h3><div>This study was funded by the <span>Brazilian Ministry of Health</span>, through the <span>Unified Health System</span>–<span>Institutional Development Support Program</span> (PROADI-SUS).</div></div>","PeriodicalId":29783,"journal":{"name":"Lancet Regional Health-Americas","volume":"39 ","pages":"Article 100923"},"PeriodicalIF":7.0000,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Lancet Regional Health-Americas","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2667193X24002503","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"HEALTH CARE SCIENCES & SERVICES","Score":null,"Total":0}

引用次数: 0

Abstract

Background

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.

Methods

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”.

Findings

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.

Interpretation

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.

Funding

This study was funded by the Brazilian Ministry of Health, through the Unified Health System–Institutional Development Support Program (PROADI-SUS).

查看原文本刊更多论文

巴西公共卫生系统中 2 型糖尿病患者的远程会诊：随机、实用、开放标签、第 2 阶段、非劣效试验（TELECONSULTA 糖尿病试验）

背景本研究针对 2 型糖尿病日益加重的负担，探讨了远程会诊作为糖尿病管理替代方法的潜力。研究的主要目的是验证一个假设，即对于从初级医疗机构转诊到统一卫生系统内专科医疗机构的 2 型糖尿病患者，在以糖化血红蛋白 (HbA1c) 为指标的血糖控制方面，远程会诊并不优于面对面会诊（两组间 HbA1c 差异的置信区间上限为 0.5%）。方法TELECONSULTA 是一项随机、务实、第 2 阶段、单中心、开放标签、非劣效试验，在巴西儒安维尔进行。共有 278 名确诊为 2 型糖尿病的患者通过初级保健医疗单位的强制性远程咨询服务接受了随机治疗。远程会诊或面对面会诊的随机分配比例为 1:1。该研究已在巴西临床试验注册中心注册，代码为 RBR-8gpgyd。研究状态为 "已完成"。研究结果这项研究的意向治疗（ITT）分析包括 278 名参与者。中位年龄为 61（54-68）岁，167（60%）人为女性。在修正意向治疗（mITT）人群中，组间比较的 HbA1c 平均降幅在 3 个月时为 -0.6% (90% CI -1.0; -0.1)，在 6 个月时为 -0.5% (90% CI -0.9; 0.0)。无缺失数据估算和按方案人群的结果相似。结果强调了远程医疗在全民医疗保健系统框架内解决糖尿病管理复杂问题的变革潜力，为医疗保健政策制定者和从业人员寻求创新解决方案以应对日益严重的糖尿病流行病提供了宝贵的见解。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Lancet Regional Health-Americas Multiple-

CiteScore

8.00

自引率

0.00%

发文量

期刊介绍： The Lancet Regional Health – Americas, an open-access journal, contributes to The Lancet's global initiative by focusing on health-care quality and access in the Americas. It aims to advance clinical practice and health policy in the region, promoting better health outcomes. The journal publishes high-quality original research advocating change or shedding light on clinical practice and health policy. It welcomes submissions on various regional health topics, including infectious diseases, non-communicable diseases, child and adolescent health, maternal and reproductive health, emergency care, health policy, and health equity.