Eventos adversos associados ao uso do sistema de infusão contínua de insulina: uma investigação sobre a segurança do paciente
Data
2024-02-29
Autores
Neves, Ana Lúcia Domingues 
Orientadores
Uchiyama, Tatiana de Sousa da Cunha
Tipo
Tese de doutorado
Título da Revista
ISSN da Revista
Título de Volume
Resumo
Objetivo: Identificar os eventos adversos (EAs) associados ao uso dos Sistemas de Infusão Contínua de Insulina (SICIs) comercialmente disponíveis no Brasil, com foco em ocorrências relacionadas ao dispositivo, conjunto de infusão de insulina (CII) e baterias. Métodos: Um total de 189 pacientes atendidos no Ambulatório de Bomba de Insulina do Centro de Diabetes da Universidade Federal de São Paulo (UNIFESP) foram convidados a participar de uma entrevista online. Os participantes foram solicitados a responder a 18 perguntas relacionadas à sua condição, ao dispositivo utilizado, sua usabilidade e ao uso do conjunto de infusão de insulina (CII) por meio de videochamadas conduzidas pela pesquisadora no aplicativo WhatsApp (período de janeiro a julho de 2021). O questionário semi-estruturado foi previamente validado pela equipe de profissionais no local de pesquisa. Após recusas e falta de resposta, a amostra do estudo consistiu em 118 voluntários com diagnóstico confirmado de Diabetes Mellitus Tipo 1 (DM1), em terapia insulínica com o SICI por um período mínimo de 6 meses. A pesquisa incluiu 71 mulheres e 47 homens, com idades entre 2 e 55 anos (média de idade 10 e 29 anos, para a população pediátrica e adulta, respectivamente), predominantemente de cor branca (74,5%), residentes no estado de São Paulo (98,3%) e com Ensino Superior completo (22,8%). O estudo foi dividido em quatro fases: F1: Fundamentação teórica para tratar o problema de pesquisa, F2: Coleta de dados, F3: Caracterização dos EAs associados ao uso do SICI e F4: Caracterização da prevalência dos EAs associados ao uso do SICI. Resultados: Os fabricantes com maior quantidade de dispositivos no estudo foram Roche, seguido pela Medtronic e Tandem Diabetes Care. Não foram identificadas correlações significativas entre as variáveis do perfil demográfico analisadas (anos de experiência no uso do dispositivo e grau de escolaridade) e o número de EAs em nenhuma faixa etária. O perfil de usuário não influenciou a ocorrência de EAs na população estudada. Foram identificados 159 EAs de causas gerais, organizados em uma taxonomia com cinco grupos: 1. Interface do usuário do SICI, 2. Sistema de Alerta do SICI, 3. Software e Conexão do SICI, 4. Durabilidade do SICI e 5. Sistema Elétrico e Mecânico do SICI. Os problemas relacionados à bateria foram os mais comuns, independentemente da marca da bateria em uso. Esses eventos variaram significativamente entre os diferentes modelos de dispositivos fabricados pela Medtronic, com 2 EAs relatados para MiniMed® ParadigmTM 722, 3 EAs para MiniMed® ParadigmTM 715, 17 EAs para MiniMed® ParadigmTM Veo 754 e, finalmente, 1 EA para MiniMed ® 640G. Os EAs relacionados ao cateter incluíram nós, dobras e tração acidental, enquanto aqueles relacionados à cânula envolveram tração acidental, descolamento do adesivo, vazamento de insulina peri e intra-canular e sangramento local. Conclusão: O uso do SICI está associado à ocorrência de EAs relacionados ao dispositivo, bateria e CII em uma população específica caracterizada demograficamente por uma idade mínima de 2 anos e máxima de 55 anos, sendo predominantemente branca, do sexo feminino, residente no estado de São Paulo e com ensino superior completo. Os potenciais EAs incluem questões mecânicas e de software, como a ocorrência de mensagens de erro do motor seguidas de ejeção do cartucho inferior, além de falhas na conectividade Bluetooth entre o dispositivo e a unidade de controle. Problemas no sistema elétrico relacionados às baterias dos dispositivos são comuns, ressaltando a persistência de alertas mesmo após a substituição da bateria. EAs graves podem ocorrer mesmo quando o alarme de oclusão não está ativado, resultando em interrupções no fluxo de insulina. Em situações menos graves, o alarme pode ser acionado mesmo na ausência de interrupção do fluxo de insulina. Integrar essas descobertas na educação sobre DM e nos protocolos de tratamento não apenas reforça a segurança, mas também minimiza a incidência de EAs.
Objective: To identify adverse events (AEs) associated with the use of commercially available Continuous Subcutaneous Insulin Infusion (CSII) in Brazil, focusing on occurrences related to the device, insulin infusion set (IIS), and batteries. Methods: A total of 189 patients treated at the Diabetes Center Insulin Pump Ambulatory, Federal University of São Paulo (UNIFESP) were invited to participate in an online interview. Participants were asked to respond to 18 questions related to their condition, the device used, its usability, and the use of the IIS through video calls conducted by the researcher on the WhatsApp application (period January to July 2021). The semi-structured questionnaire was previously validated by the team of professionals at the research site. After refusals and non-responses, the study sample consisted of 118 volunteers diagnosed with Type 1 Diabetes Mellitus (DM1), who had been on insulin therapy with the CSII for a minimum period of 6 months. The research involved 71 women and 47 men, aged 2 to 55 years ( 10 and 29 years, for the pediatric and adult population, respectively), predominantly white (74.5%), residents of the state of São Paulo (98.3%), and with complete higher education (22.8%). The study was divided into four phases: F1: Theoretical foundation to address the research problem, F2: Data collection, F3: Characterization of AEs associated with the use of CSII, and F4: Characterization of the prevalence of AEs associated with the use of CSII. Results: The manufacturers with the highest number of devices in the study were Roche, followed by Medtronic and Tandem Diabetes Care. No significant correlations were identified between the analyzed demographic profile variables (years of experience in device use and level of education) and the number of AEs in any age group. The user profile did not influence the occurrence of AEs in the studied population. A total of 159 AEs of general causes were identified and organized into a taxonomy with five groups: 1. CSII user interface, 2. CSII alert system, 3. CSII software and connection, 4. CSII durability, and 5. CSII electrical and mechanical system. Battery-related problems were the most common, regardless of the battery brand in use. These events varied significantly among the different device models manufactured by Medtronic, with 2 AEs reported for MiniMed® ParadigmTM 722, 3 AEs for MiniMed® ParadigmTM 715, 17 AEs for MiniMed® ParadigmTM Veo 754, and finally, 1 AE for MiniMed ® 640G. Catheter-related AEs included knots, bends, and accidental traction, while those related to the cannula involved accidental traction, adhesive detachment, peri and intra-cannular insulin leakage, and local bleeding. Conclusion: The use of CSII is associated with the occurrence of AEs related to the device, battery, and IIS in a specific population characterized demographically by a minimum age of 2 years and a maximum of 55 years, predominantly white, female, residents of the state of São Paulo, and with complete higher education. Potential AEs include mechanical and software issues, such as motor error messages followed by lower cartridge ejection, as well as failures in Bluetooth connectivity between the device and the control unit. Problems in the electrical system related to device batteries are common, highlighting the persistence of alerts even after battery replacement. Serious AEs can occur even when the occlusion alarm is not activated, resulting in interruptions in insulin flow. In less severe situations, the alarm may be triggered even in the absence of insulin flow interruption. Integrating these findings into DM education and treatment protocols not only reinforces safety but also minimizes the incidence of AEs.
Objective: To identify adverse events (AEs) associated with the use of commercially available Continuous Subcutaneous Insulin Infusion (CSII) in Brazil, focusing on occurrences related to the device, insulin infusion set (IIS), and batteries. Methods: A total of 189 patients treated at the Diabetes Center Insulin Pump Ambulatory, Federal University of São Paulo (UNIFESP) were invited to participate in an online interview. Participants were asked to respond to 18 questions related to their condition, the device used, its usability, and the use of the IIS through video calls conducted by the researcher on the WhatsApp application (period January to July 2021). The semi-structured questionnaire was previously validated by the team of professionals at the research site. After refusals and non-responses, the study sample consisted of 118 volunteers diagnosed with Type 1 Diabetes Mellitus (DM1), who had been on insulin therapy with the CSII for a minimum period of 6 months. The research involved 71 women and 47 men, aged 2 to 55 years ( 10 and 29 years, for the pediatric and adult population, respectively), predominantly white (74.5%), residents of the state of São Paulo (98.3%), and with complete higher education (22.8%). The study was divided into four phases: F1: Theoretical foundation to address the research problem, F2: Data collection, F3: Characterization of AEs associated with the use of CSII, and F4: Characterization of the prevalence of AEs associated with the use of CSII. Results: The manufacturers with the highest number of devices in the study were Roche, followed by Medtronic and Tandem Diabetes Care. No significant correlations were identified between the analyzed demographic profile variables (years of experience in device use and level of education) and the number of AEs in any age group. The user profile did not influence the occurrence of AEs in the studied population. A total of 159 AEs of general causes were identified and organized into a taxonomy with five groups: 1. CSII user interface, 2. CSII alert system, 3. CSII software and connection, 4. CSII durability, and 5. CSII electrical and mechanical system. Battery-related problems were the most common, regardless of the battery brand in use. These events varied significantly among the different device models manufactured by Medtronic, with 2 AEs reported for MiniMed® ParadigmTM 722, 3 AEs for MiniMed® ParadigmTM 715, 17 AEs for MiniMed® ParadigmTM Veo 754, and finally, 1 AE for MiniMed ® 640G. Catheter-related AEs included knots, bends, and accidental traction, while those related to the cannula involved accidental traction, adhesive detachment, peri and intra-cannular insulin leakage, and local bleeding. Conclusion: The use of CSII is associated with the occurrence of AEs related to the device, battery, and IIS in a specific population characterized demographically by a minimum age of 2 years and a maximum of 55 years, predominantly white, female, residents of the state of São Paulo, and with complete higher education. Potential AEs include mechanical and software issues, such as motor error messages followed by lower cartridge ejection, as well as failures in Bluetooth connectivity between the device and the control unit. Problems in the electrical system related to device batteries are common, highlighting the persistence of alerts even after battery replacement. Serious AEs can occur even when the occlusion alarm is not activated, resulting in interruptions in insulin flow. In less severe situations, the alarm may be triggered even in the absence of insulin flow interruption. Integrating these findings into DM education and treatment protocols not only reinforces safety but also minimizes the incidence of AEs.
Descrição
Citação
NEVES, Ana Lúcia Domingues. Eventos adversos associados ao uso do sistema de infusão contínua de insulina: uma investigação sobre a segurança do paciente. 2024. 175 f. Tese (Doutorado em Medicina Translacional) - Escola Paulista de Medicina, Universidade Federal de São Paulo (UNIFESP). São Paulo, 2024.