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胰岛素APP的十年:自首次发表以来使用COSMIN进行的验证及临床进展

A decade of InsulinAPP: validation using COSMIN and clinical advancements since its initial publication.

作者信息

Kakitani Toyoshima Marcos Tadashi, Lavinas-Jones Julia Mandaro, Feitosa Alina Coutinho Rodrigues, Nery Marcia

机构信息

Department of Endocrinology and Metabolism, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.

Endocrine Oncology Service, Instituto do Câncer do Estado de São Paulo Octávio Frias de Oliveira, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.

出版信息

Diabetol Metab Syndr. 2025 May 10;17(1):150. doi: 10.1186/s13098-025-01717-5.

Abstract

This correspondence marks the 10-year milestone of InsulinAPP, a Brazilian-developed electronic glycemic management system (eGMS) designed to support inpatient insulin therapy. Initially published in 2015, InsulinAPP was developed to assist non-specialist physicians in applying evidence-based insulin protocols in hospital settings. Over the past decade, it has evolved into a validated clinical decision-support tool with demonstrated impact across multiple care contexts. In this manuscript, we present a structured overview of its validation using the COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) framework, assessing five core domains: cross-cultural adaptation, content validity, criterion validity, reliability, and construct validity. Usability testing showed high acceptance (mean Likert score 4.8/5), and expert consensus on content validity was strong (Content Validity Index = 0.95). The tool also demonstrated high reproducibility (intraclass correlation coefficient = 0.98), and in a randomized trial, glycemic control with InsulinAPP was comparable to endocrinologist-led care, with low hypoglycemia rates. Compared to other eGMS solutions, InsulinAPP stands out for its simplicity, independence from electronic health record integration, and adaptability to low-resource environments. Its protocol anticipated updates later adopted by the Endocrine Society and the Brazilian Diabetes Society, particularly regarding stratified insulinization for patients with mild-to-moderate hyperglycemia. Together, these findings confirm InsulinAPP's scientific soundness, safety, and real-world applicability. Broader implementation and multicenter studies are warranted to further explore its impact in diverse healthcare systems and improve access to safe inpatient glycemic management.

摘要

这封通信标志着InsulinAPP诞生10周年,InsulinAPP是巴西研发的一款电子血糖管理系统(eGMS),旨在支持住院患者的胰岛素治疗。InsulinAPP最初于2015年发布,旨在帮助非专科医生在医院环境中应用循证胰岛素方案。在过去十年中,它已发展成为一种经过验证的临床决策支持工具,在多个护理环境中都产生了显著影响。在本手稿中,我们使用COSMIN(基于共识的健康测量工具选择标准)框架对其验证进行了结构化概述,评估了五个核心领域:跨文化适应性、内容效度、标准效度、信度和结构效度。可用性测试显示接受度很高(平均李克特评分4.8/5),并且在内容效度方面专家共识强烈(内容效度指数=0.95)。该工具还显示出高再现性(组内相关系数=0.98),并且在一项随机试验中,使用InsulinAPP进行血糖控制与内分泌专家主导的护理相当,低血糖发生率较低。与其他eGMS解决方案相比,InsulinAPP因其简单性、独立于电子健康记录集成以及对低资源环境的适应性而脱颖而出。其方案预期的更新后来被内分泌学会和巴西糖尿病学会采用,特别是关于轻度至中度高血糖患者的分层胰岛素治疗。总之,这些发现证实了InsulinAPP的科学合理性、安全性和实际适用性。有必要进行更广泛的实施和多中心研究,以进一步探索其在不同医疗系统中的影响,并改善安全住院血糖管理的可及性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/36ed/12065289/75053bad5256/13098_2025_1717_Fig1_HTML.jpg

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