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

NCT04903496 | Completed Results

• 1 other identifier: 1245-0203
• Study Type: observational
• Target: 1,233,162
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

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

  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.

  up to 5 years (2015 up to 2019)

Secondary Outcomes (24)

• 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

Study Arms (4)

In- and outpatients: diabetic with risk factors (RF) [Arm A]

In- and outpatients with diagnosis of diabetes, and with diagnosis of risk factors cardiovascular disease (CVD), heart failure (HF), chronic kidney disease (CKD) or at high cardiovascular (CV) risk identified in the Tianjin regional medical database.

In- and outpatients: diabetic without RF [Arm B]

In- and outpatients with diagnosis of diabetes, but not with diagnosis of risk factors CVD, HF, CKD or at high CV risk identified in the Tianjin regional medical database.

In- and outpatients: non-diabetic with RF [Arm C]

In- and outpatients without diabetes but with diagnosis of risk factors CVD, HF, CKD or at high CV risk identified in the Tianjin regional medical database.

In- and outpatients: non-diabetic without RF [Arm D]

In- and outpatients without diabetes and without diagnosis of risk factors CVD, HF, CKD or at high CV risk identified in the Tianjin regional medical database.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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);

You may not qualify if:

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

Sponsors & Collaborators

• Boehringer Ingelheim: lead
• Chengdu Big Data Association: collaborator

Study Sites (1)

Chengdu Big Data Association

Chengdu, 610041, China

Location

Related Links

• Related Info

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2021
• First Posted: May 26, 2021
• Study Start: September 6, 2021
• Primary Completion: June 24, 2022
• Study Completion: June 24, 2022
• Last Updated: November 12, 2024
• Results First Posted: November 12, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)