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

Boehringer Ingelheim1 site in 1 country1,233,162 target enrollmentSeptember 6, 2021

ConditionsDiabetes

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Diabetes
Sponsor: Boehringer Ingelheim
Enrollment: 1233162
Locations: 1
Primary Endpoint: Number of Participants With Established Cardiovascular Disease, or Chronic Kidney Disease, or High Cardiovascular Risk
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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

Registry

clinicaltrials.gov

Start Date

September 6, 2021

End Date

June 24, 2022

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Boehringer Ingelheim

Responsible Party

Sponsor

Eligibility Criteria

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;

Exclusion Criteria

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

Outcomes

Primary Outcomes

Number of Participants With Established Cardiovascular Disease, or Chronic Kidney Disease, or High Cardiovascular Risk

Time Frame: up to 5 years (2015 up to 2019)

Number of participants with established cardiovascular disease (CVD), chronic kidney disease (CKD), and/or high cardiovascular (CV) risk was calculated as (100%\* Number of patients with labels of interested diseases from 2015 to the given year)/ (Number of diabetic or non-diabetic patients from 2015 to the given year). To compare diabetic with non-diabetic patients within a year and across years * the arms with diabetic in- and outpatients \[Arm A and B together\] were combined * the arms with non-diabetic in- and outpatients \[Arm C and D together\] were combined by year. Patients with risk factors were patients with diagnosis of CVD, HF, CKD or at high CV risk. Each participant could potentially have multiple diagnoses simultaneously. The data presented for this outcome is an retrospective analysis of electronic healthcare records of the Tianjin regional data base. Participants with diagnoses of interest were identified by International Classification of Disease (ICD) code.

Secondary Outcomes

Mean Age of Inpatients and All Participants (In-and Outpatients) at Their Last Visit in 2015(Last visit in 2015, up to 1 day)
Mean Age of Inpatients and All Participants (In-and Outpatients) at Their Last Visit in 2017(Last visit in 2017, up to 1 day)
Mean Age of Inpatients and All Participants (In-and Outpatients) at Their Last Visit in 2019(Last visit in 2019, up to 1 day)
Number of Female and Male Inpatients and All Participants (In-and Outpatients) at Their Last Visit in 2015(Last visit in 2015, up to 1 day)
Number of Female and Male Inpatients and All Participants (In-and Outpatients) at Their Last Visit in 2017(Last visit in 2017, up to 1 day)
Number of Female and Male Inpatients and All Participants (In-and Outpatients) at Their Last Visit in 2019(Last visit in 2019, up to 1 day)
Number of Inpatients and All Participants (In-and Outpatients) With Insurance Payment at Their Last Visit in 2015(Last visit in 2015, up to 1 day)
Number of Inpatients and All Participants (In-and Outpatients) With Insurance Payment at Their Last Visit in 2017(Last visit in 2017, up to 1 day)
Number of Inpatients and All Participants (In-and Outpatients) With Insurance Payment at Their Last Visit in 2019(Last visit in 2019, up to 1 day)
Number of Inpatients and All Participants (In-and Outpatients) by Discharge Department at Their Last Visit in 2015(Last visit in 2015, up to 1 day)
Number of Inpatients and All Participants (In-and Outpatients) by Discharge Department at Their Last Visit in 2017(Last visit in 2017, up to 1 day)
Number of Inpatients and All Participants (In-and Outpatients) by Discharge Department at Their Last Visit in 2019(Last visit in 2019, up to 1 day)
Number of Deaths in Inpatients and All Participants (In-and Outpatients) at Their Last Visit in 2015(On the last visit (1 day) in 2015 data was retrospectively assessed for the last 12 months in 2015.)
Number of Deaths in Inpatients and All Participants (In-and Outpatients) at Their Last Visit in 2017(On the last visit (1 day) in 2017 data was retrospectively assessed for the last 12 months in 2017.)
Number of Deaths in Inpatients and All Participants (In-and Outpatients) at Their Last Visit in 2019(On the last visit (1 day) in 2019 data was retrospectively assessed for the last 12 months in 2019.)
The Value of Glycated Hemoglobin (HbA1c) in Inpatients and in All Participants (in- and Outpatients) at Their Last Visit in 2015(Last visit in 2015, up to 1 day)
The Value of Glycated Hemoglobin (HbA1c) in Inpatients and in All Participants (in- and Outpatients) at Their Last Visit in 2017(Last visit in 2017, up to 1 day)
The Value of Glycated Hemoglobin (HbA1c) in Inpatients and in All Participants (in- and Outpatients) at Their Last Visit in 2019(Last visit in 2019, up to 1 day)
Concentration of Random Blood Glucose in Inpatients and in All Participants (in- and Outpatients) at Their Last Visit in 2015(Last visit in 2015, up to 1 day)
Concentration of Random Blood Glucose in Inpatients and in All Participants (in- and Outpatients) at Their Last Visit in 2017(Last visit in 2017, up to 1 day)
Concentration of Random Blood Glucose in Inpatients and in All Participants (in- and Outpatients) at Their Last Visit in 2019(Last visit in 2019, up to 1 day)
Serum Creatine Concentration in Inpatients and in All Participants (in- and Outpatients) at Their Last Visit in 2015(Last visit in 2015, up to 1 day)
Serum Creatine Concentration in Inpatients and in All Participants (in- and Outpatients) at Their Last Visit in 2017(Last visit in 2017, up to 1 day)
Serum Creatine Concentration in Inpatients and in All Participants (in- and Outpatients) at Their Last Visit in 2019(Last visit in 2019, up to 1 day)