{"title":"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）","authors":"","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":null,"pages":null},"PeriodicalIF":7.0000,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"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\":\"\",\"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\":null,\"pages\":null},\"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}","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}
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)
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).
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.
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