A Decade of InsulinAPP: Validation Using COSMIN and Clinical Advancements Since Its Initial Publication

• DOI: 10.21203/rs.3.rs-5844918/v1
• Publication Date: 2025-04-10T06:50:31Z
• Authors: Marcos Tadashi Ka...; Julia Mandaro Lav...; Alina Coutinho Ro...; Marcia Nery

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.