RESUMO
BACKGROUND: Providing optimal care for type 2 diabetes (DM2) patients remains a challenge for all healthcare systems. Patients often encounter various barriers in adhering to self-management programs due to lack of knowledge and understanding of self-care activities, lack of individualized and coordinated care, inconvenient and costly education sessions, and poor patient-provider communication. Mobile technologies such as cell phones/smartphones, handheld tablets, and other wireless devices offer new and exciting opportunities for addressing some of these challenges. The purpose of this study is to compare a diabetes management strategy using an information board and a mobile application versus standard care in patients with uncontrolled DM2. METHOD: The SANENT (Sistema de Análisis de Enfermedades No Transmisibles) trial is a primary care-based, prospective, two-arm, randomized controlled, open-label, blinded-endpoint study. We aim to recruit 1440 DM2 patients during a period of 6 months until the requested number of participants has been achieved. The total length of the intervention will be 1 year. Both men and women treated for DM2 with an HbA1c > 8.5% and ≥ 20 years of age are eligible to participate in the study. The primary outcome of the study is improved diabetes control measured by changes in HbA1c in the study participants. HbA1c will be measured at baseline, 3-month, 6-month, 9-month, and 12-month follow-up visits in all participants. The main analysis will be based on the intention-to-treat principle. The primary endpoint of the study will be the change in HbA1C within the groups and the differences between the groups. This will be assessed by a repeated measurement approach based on mixed models which contain both fixed effects and random effects. DISCUSSION: The overall goal of this project is to contribute to the evidence for the use of mobile technology to improve the treatment and regulation of poorly controlled DM2 patients living in Mexico. Our proposed project will show how mobile health technology tools can be used in the treatment of patients with uncontrolled DM2 in primary health care in a Latin American population, and particularly how they could help diabetes patients take better care of themselves. TRIAL REGISTRATION: ClinicalTrials.gov , US National Institutes of Health NCT04974333 . Prospectively registered on July 13, 2021. Protocol version number 1, dated August 15th, 2021.
Assuntos
Diabetes Mellitus Tipo 2 , Aplicativos Móveis , Diabetes Mellitus Tipo 2/diagnóstico , Diabetes Mellitus Tipo 2/terapia , Feminino , Humanos , Sistemas de Informação , Masculino , México , Atenção Primária à Saúde , Estudos Prospectivos , Ensaios Clínicos Controlados Aleatórios como Assunto , Estados UnidosRESUMO
Objetivo Averiguar ¿Cuál de los dos factores es más nocivo? ¿Cuál es la magnitud de su efecto? y ¿Qué pasa cuando alguien se expone a ambos factores a la vez? Métodos Estudio ecológico que evalúa la asociación epidemiológica (riesgo relativo) entre la contaminación atmosférica y el tabaquismo con la función pulmonar, evaluada mediante espirometría funcional en 489 adultos. Se comparan dos ambientes con diferentes niveles de contaminación, 30 y 60 µg/m³ de material particulado respirable (PM10) y grupos de fumadores contra no fumadores. Resultados La función pulmonar está disminuida (VEF1<80 %) en los fumadores en mayor proporción que en los no fumadores, con un exceso de riesgo de 52 % (RR. 1,52 IC95 % 1,11-2,07). Las personas expuestas a un mayor nivel de contaminación ambiental presentan una mayor proporción de disfunción pulmonar con un exceso de riesgo de 64 % (RR. 1,64 IC95 % 1,19-2,25). Cuando los sujetos se exponen a ambos factores, es decir fuman y además se encuentran en ambientes contaminados, el exceso de riesgo es del 129 % (RR 2,29 IC95 % 1,45-3,61). Conclusiones Las personas que respiran ambientes contaminados presentan disfunción pulmonar en una magnitud similar o superior a la que presentan los fumadores, es decir, podríamos afirmar que en relación con los efectos, respirar aire contaminado equivale a estar fumando, solo que en contra de la voluntad.(AU)
Objective We want to determine: ¿Which of the two factors is more harmful? ¿What is the magnitude of its effect? and ¿What happens when someone is exposed to both factors at once?. Methods An ecological study that evaluates the epidemiological association (relative risk) between air pollution and smoking with lung functions as assessed by functional spirometry in 489 adults. We compare two environments with different pollution levels 30 and 60 g/m³ of particulate matter (PM10) and groups of smokers against nonsmokers. Results Lung function is impaired (FEV1 <80 %) in smokers at higher rates than the non-smokers, with an excess risk of 52 % (RR. 1.52 CI 95 % 1.11 -2.07). People exposed to higher levels of pollution have a higher proportion of pulmonary dysfunction than those exposed to less polluted environments with an excess risk of 64 % (RR. 1,64 CI 95% 1.19-2.25). When subjects are exposed to both factors, that is smokers who also live in contaminated environments, the excess of risk reaches 129 % (RR 2.29 CI 95 % 1.45-3.61). Conclusions People who breathe in polluted environments have impaired lung function in a similar magnitude or greater than smokers. Therefore, we could say that breathing contaminated air is equivalent to smoking, but sadly it occurs against the affected party's will.(AU)
Assuntos
Humanos , Nicotiana/efeitos adversos , Poluição do Ar/efeitos adversos , Pneumopatias/etiologia , Espirometria/instrumentação , Estudos EcológicosRESUMO
Objective We want to determine: ¿Which of the two factors is more harmful? ¿What is the magnitude of its effect? and ¿What happens when someone is exposed to both factors at once?. Methods An ecological study that evaluates the epidemiological association (relative risk) between air pollution and smoking with lung functions as assessed by functional spirometry in 489 adults. We compare two environments with different pollution levels 30 and 60 g/m³ of particulate matter (PM10) and groups of smokers against nonsmokers. Results Lung function is impaired (FEV1 <80 %) in smokers at higher rates than the non-smokers, with an excess risk of 52 % (RR. 1.52 CI 95 % 1.11 -2.07). People exposed to higher levels of pollution have a higher proportion of pulmonary dysfunction than those exposed to less polluted environments with an excess risk of 64 % (RR. 1,64 CI 95% 1.19-2.25). When subjects are exposed to both factors, that is smokers who also live in contaminated environments, the excess of risk reaches 129 % (RR 2.29 CI 95 % 1.45-3.61). Conclusions People who breathe in polluted environments have impaired lung function in a similar magnitude or greater than smokers. Therefore, we could say that breathing contaminated air is equivalent to smoking, but sadly it occurs against the affected party's will.