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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04903496
• Other study ID #: 1245-0203
• Status: Completed
• Start date: September 6, 2021
• Est. completion date: June 24, 2022

Study information

• Verified date: July 2022
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100000
• Est. completion date: June 24, 2022
• Est. primary completion date: June 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes

Locations

Country	Name	City	State
China	Chengdu Big Data Association	Chengdu

Sponsors (2)

Lead Sponsor	Collaborator
Boehringer Ingelheim	Chengdu Big Data Association

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of diabetic/non-diabetic patients with established cardiovascular disease, or chronic kidney disease, or at high cardiovascular risk		up to 4 years
Primary	The proportion of diabetic patients with established cardiovascular disease, or chronic kidney disease, or at high cardiovascular risk among all diabetic patients		up to 4 years
Primary	The proportion of non-diabetic patients with established cardiovascular disease, or chronic kidney disease, or at high cardiovascular risk among all non-diabetic patients		up to 4 years
Secondary	Age at admission at the latest visit for all patients, as well as the trends for inpatients over time (2015, 2017, and 2019 respectively)		up to 4 years
Secondary	Gender at the latest visit for all patients, as well as the trends for inpatients over time (2015, 2017, and 2019 respectively)		up to 4 years
Secondary	Insurance payment at the latest visit for all patients, as well as the trends for inpatients over time (2015, 2017, and 2019 respectively)		up to 4 years
Secondary	Discharge department at the latest visit for all patients, as well as the trends for inpatients over time (2015, 2017 and 2019 respectively)		up to 4 years
Secondary	Proportion of death at the latest visit for all patients, as well as the trends for inpatients over time (2015, 2017 and 2019 respectively)		up to 4 years
Secondary	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)		up to 4 years
Secondary	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)		up to 4 years
Secondary	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)		up to 4 years

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