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Clinical Characteristics and Disease Burden of Diabetic Patients Based on Tianjin Regional Database

14 de julho de 2022 atualizado por: Boehringer Ingelheim

Characteristics, Treatment, and Economic Burden of Disease of Chinese Diabetic/Non-diabetic Patients With/Without Established Cardiovascular Disease, Chronic Kidney Disease, or at High Cardiovascular Risk

The study aims to investigate the clinical characteristics, treatment, and economic burden of disease of Chinese diabetic/non-diabetic patients with/without established cardiovascular disease (CVD), chronic kidney disease (CKD), or at high cardiovascular risk, including:

  • Primary objectives: describe the proportion of Chinese diabetic/non-diabetic patients with established cardiovascular disease, CKD, or at high cardiovascular risk including hypertension and hyperlipidemia
  • Secondary objectives: describe the demographic characteristics of the last visit for all patients, and the demographic characteristics of inpatients over time; investigate the clinical characteristic for all patients

Visão geral do estudo

Status

Concluído

Condições

Tipo de estudo

Observacional

Inscrição (Real)

100000

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

      • Chengdu, China, 610041
        • Chengdu Big Data Association

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

Diabetic/non-diabetic patients with/without established cardiovascular disease, chronic kidney disease, or at high cardiovascular risk.

Descrição

Inclusion Criteria:

  • Patients in the Tianjin regional database from 01/01/2015 to 31/12/2019
  • Group A: patients with diagnosis of diabetes, and with diagnosis of cardiovascular disease, heart failure, chronic kidney disease or at high cardiovascular risk
  • Group B: patients with diagnosis of diabetes, but not with diagnosis of cardiovascular disease, heart failure, chronic kidney disease or at high cardiovascular risk
  • Group C: patients with diagnosis of cardiovascular disease, heart failure, chronic kidney disease or at high cardiovascular risk, but not with diagnosis of diabetes
  • Group D: patients without diagnosis of cardiovascular disease, heart failure, chronic kidney disease or at high cardiovascular risk, and without diagnosis of diabetes. We will randomly select a group of non-diabetic patients without any of the above diseases by matching on age and gender

Definition of diabetes, cardiovascular disease, chronic kidney disease and high cardiovascular risk:

  • Diabetes: patients with at least 1 discharged diagnosis or 2 outpatient diagnosis of diabetes (the first diagnosis will be the index diagnosis, and the time interval between diagnoses is not restricted) (International classification of disease (ICD)-10 E10-E14);
  • Cardiovascular disease: patients with at least 1 discharged diagnosis or 2 outpatient diagnosis of ischemic heart diseases (the first diagnosis will be the index diagnosis, and the time interval between diagnoses is not restricted) (ICD-10 I20~I25); or patients with at least 1 discharged diagnosis or 2 outpatient diagnosis of cerebrovascular diseases (the first diagnosis will be the index diagnosis, and the time interval between diagnoses is not restricted) (ICD-10 I60~I69); or patients with at least 1 discharged diagnosis or 2 outpatient diagnosis of ischemic peripheral artery disease (the first diagnosis will be the index diagnosis, and the time interval between diagnoses is not restricted) (ICD-10 E10.501, E11.603, E14.501, E14.606, E14.503, I73.9, I99.03, I99.04);
  • Heart failure: patients with at least 1 discharged diagnosis or 2 outpatient diagnosis of heart failure (the first diagnosis will be the index diagnosis, and the time interval between diagnoses is not restricted) (ICD-10 I50);
  • Chronic kidney disease (CKD): inpatients with at least once 1 discharged diagnosis CKD (ICD-10 N18), or inpatients with the last estimated glomerular filtration rate (eGFR, calculated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation) <60 mL/min/1.73 m2 or prescription of dialysis, but not with the diagnosis of acute kidney injury (ICD-10 N17); or outpatients with at least 2 diagnosis of CKD (the first diagnosis will be the index diagnosis, and the time interval between diagnoses is not restricted) or with two consecutive eGFR (calculated by CKD-EPI equation) <60 mL/min/1.73 m2 by 90 days or more;
  • High cardiovascular risk: patients with at least 1 discharged diagnosis or 2 outpatient diagnosis of hypertension (the first diagnosis will be the index diagnosis, and the time interval between diagnoses is not restricted) (ICD-10 I10~I15); or at least 1 discharged diagnosis or 2 outpatient diagnosis of hyperlipidemia (ICD-10 E78.001-E78.003, E78.101, E78.203, E78.301-E78.304, E78.306, E78.401, E78.501, E78.902);

Exclusion Criteria:

  • Patients with non-Chinese nationalities
  • Duplicated storage (records with same inpatient code)

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Group A: Diabetic patients with CVD, CKD or at risk
The group A includes all Patients with diagnosis of diabetes, and with diagnosis of cardiovascular disease, heart failure, chronic kidney disease or at high cardiovascular risk.
Group B: Diabetic patients without CVD, CKD or at risk
The group B includes all patients with diagnosis of diabetes, but not with diagnosis of cardiovascular disease, heart failure, chronic kidney disease or at high cardiovascular risk.
Group C: Non-diabetic patients with CVD, CKD or at risk
The group C includes all patients with diagnosis of cardiovascular disease, heart failure, chronic kidney disease or at high cardiovascular risk, but not with diagnosis of diabetes.
Group D: Non-diabetic patients without CVD, CKD or at risk
The group D includes all patients without diagnosis of cardiovascular disease, heart failure, chronic kidney disease or at high cardiovascular risk, and without diagnosis of diabetes.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Prazo
The proportion of diabetic/non-diabetic patients with established cardiovascular disease, or chronic kidney disease, or at high cardiovascular risk
Prazo: up to 4 years
up to 4 years
The proportion of diabetic patients with established cardiovascular disease, or chronic kidney disease, or at high cardiovascular risk among all diabetic patients
Prazo: up to 4 years
up to 4 years
The proportion of non-diabetic patients with established cardiovascular disease, or chronic kidney disease, or at high cardiovascular risk among all non-diabetic patients
Prazo: up to 4 years
up to 4 years

Medidas de resultados secundários

Medida de resultado
Prazo
Age at admission at the latest visit for all patients, as well as the trends for inpatients over time (2015, 2017, and 2019 respectively)
Prazo: up to 4 years
up to 4 years
Gender at the latest visit for all patients, as well as the trends for inpatients over time (2015, 2017, and 2019 respectively)
Prazo: up to 4 years
up to 4 years
Insurance payment at the latest visit for all patients, as well as the trends for inpatients over time (2015, 2017, and 2019 respectively)
Prazo: up to 4 years
up to 4 years
Discharge department at the latest visit for all patients, as well as the trends for inpatients over time (2015, 2017 and 2019 respectively)
Prazo: up to 4 years
up to 4 years
Proportion of death at the latest visit for all patients, as well as the trends for inpatients over time (2015, 2017 and 2019 respectively)
Prazo: up to 4 years
up to 4 years
The value of glycated hemoglobin (HbA1c) at the latest visit for all patients, as well as the trends for inpatients over time (2015, 2017 and 2019 respectively)
Prazo: up to 4 years
up to 4 years
Concentration (nmol/L) of random blood glucose at the latest visit for all patients, as well as the trends for inpatients over time (2015, 2017 and 2019 respectively)
Prazo: up to 4 years
up to 4 years
Serum creatine concentration (μmol/L) at the latest visit for all patients, as well as the trends for inpatients over time (2015, 2017, and 2019 respectively)
Prazo: up to 4 years
up to 4 years

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Publicações e links úteis

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Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

6 de setembro de 2021

Conclusão Primária (Real)

24 de junho de 2022

Conclusão do estudo (Real)

24 de junho de 2022

Datas de inscrição no estudo

Enviado pela primeira vez

25 de maio de 2021

Enviado pela primeira vez que atendeu aos critérios de CQ

25 de maio de 2021

Primeira postagem (Real)

26 de maio de 2021

Atualizações de registro de estudo

Última Atualização Postada (Real)

15 de julho de 2022

Última atualização enviada que atendeu aos critérios de controle de qualidade

14 de julho de 2022

Última verificação

1 de julho de 2022

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • 1245-0203

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).

For more details refer to: https://www.mystudywindow.com/msw/datatransparency

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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