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

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

Study Overview

• Status: Completed
• Conditions: Diabetes

• Study Type: Observational
• Enrollment (Actual): 1233162

Contacts and Locations

Study Locations

• China
  • Chengdu, China, 610041
    • Chengdu Big Data Association

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Age of Inpatients and All Participants (In-and Outpatients) at Their Last Visit in 2015	The mean age was calculated for inpatients grouped by their diagnoses category [Arm A, B, C, D - inpatients only] and for all participants [All in- and outpatients] at their last visit in 2015. The Arms A, B, C, D - inpatients only were mutually exclusive in 2015. Patients with risk factors (RF) 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.	Last visit in 2015, up to 1 day
Mean Age of Inpatients and All Participants (In-and Outpatients) at Their Last Visit in 2017	The mean age was calculated for inpatients grouped by their diagnoses category [Arm A, B, C, D - inpatients only] and for all participants [All in- and outpatients] at their last visit in 2017. The Arms A, B, C, D - inpatients only were mutually exclusive in 2017. Patients with risk factors (RF) 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.	Last visit in 2017, up to 1 day
Mean Age of Inpatients and All Participants (In-and Outpatients) at Their Last Visit in 2019	The mean age was calculated for inpatients grouped by their diagnoses category [Arm A, B, C, D - inpatients only] and for all participants [All in- and outpatients] at their last visit in 2019. The Arms A, B, C, D - inpatients only were mutually exclusive in 2019. Patients with risk factors (RF) 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.	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	The number of female and male was calculated for inpatients grouped by their diagnoses category [Arm A, B, C, D - inpatients only] and for all participants [All in- and outpatients] at their last visit in 2015. The Arms A, B, C, D - inpatients only were mutually exclusive in 2015. Patients with risk factors (RF) 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.	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	The number of female and male was calculated for inpatients grouped by their diagnoses category [Arm A, B, C, D - inpatients only] and for all participants [All in- and outpatients] at their last visit in 2017. The Arms A, B, C, D - inpatients only were mutually exclusive in 2017. Patients with risk factors (RF) 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.	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	The number of female and male was calculated for inpatients grouped by their diagnoses category [Arm A, B, C, D - inpatients only] and for all participants [All in- and outpatients] at their last visit in 2019. The Arms A, B, C, D - inpatients only were mutually exclusive in 2019. Patients with risk factors (RF) 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.	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	The number of participants with insurance payment was calculated for inpatients grouped by their diagnoses category [Arm A, B, C, D - inpatients only] and for all participants [All in- and outpatients] at their last visit in 2015. The Arms A, B, C, D - inpatients only were mutually exclusive in 2015. Patients with risk factors (RF) 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.	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	The number of participants with insurance payment was calculated for inpatients grouped by their diagnoses category [Arm A, B, C, D - inpatients only] and for all participants [All in- and outpatients] at their last visit in 2017. The Arms A, B, C, D - inpatients only were mutually exclusive in 2017. Patients with risk factors (RF) 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.	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	The number of participants with insurance payment was calculated for inpatients grouped by their diagnoses category [Arm A, B, C, D - inpatients only] and for all participants [All in- and outpatients] at their last visit in 2019. The Arms A, B, C, D - inpatients only were mutually exclusive in 2019. Patients with risk factors (RF) 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.	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	The number of participants in a particular discharge department was calculated for inpatients grouped by their diagnoses category [Arm A, B, C, D - inpatients only] and for all participants [All in- and outpatients] at their last visit in 2015. The Arms A, B, C, D - inpatients only were mutually exclusive in 2015. Patients with risk factors (RF) were patients with diagnosis of CVD, HF, CKD or at high CV risk. Each participant could potentially have multiple diagnoses and records in multiple discharge departments simultaneously. Thus, one participant could potentially occur more than once per arm. 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.	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	The number of participants in a particular discharge department was calculated for inpatients grouped by their diagnoses category [Arm A, B, C, D - inpatients only] and for all participants [All in- and outpatients] at their last visit in 2017. The Arms A, B, C, D - inpatients only were mutually exclusive in 2017. Patients with risk factors (RF) were patients with diagnosis of CVD, HF, CKD or at high CV risk. Each participant could potentially have multiple diagnoses and records in multiple discharge departments simultaneously. Thus, one participant could potentially occur more than once per arm. Thus, one participant could potentially occur more than once per arm. 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.	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	The number of participants in a particular discharge department was calculated for inpatients grouped by their diagnoses category [Arm A, B, C, D - inpatients only] and for all participants [All in- and outpatients] at their last visit in 2019. The Arms A, B, C, D - inpatients only were mutually exclusive in 2019. Patients with risk factors (RF) were patients with diagnosis of CVD, HF, CKD or at high CV risk. Each participant could potentially have multiple diagnoses and records in multiple discharge departments simultaneously. Thus, one participant could potentially occur more than once per arm. 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.	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	The number of participants who were diagnosed as dead in 2015 was calculated for inpatients grouped by their diagnoses category [Arm A, B, C, D - inpatients only] and for all participants [All in- and outpatients] at their last visit in 2015. The Arms A, B, C, D - inpatients only were mutually exclusive in 2015. Patients with risk factors (RF) 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.	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	The number of participants who were diagnosed as dead in 2017 was calculated for inpatients grouped by their diagnoses category [Arm A, B, C, D - inpatients only] and for all participants [All in- and outpatients] at their last visit in 2017. The Arms A, B, C, D - inpatients only were mutually exclusive in 2017. Patients with risk factors (RF) 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.	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	The number of participants who were diagnosed as dead in 2019 was calculated for inpatients grouped by their diagnoses category [Arm A, B, C, D - inpatients only] and for all participants [All in- and outpatients] at their last visit in 2019. The Arms A, B, C, D - inpatients only were mutually exclusive in 2019. Patients with risk factors (RF) 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.	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	The value of glycated hemoglobin (HbA1c) was calculated for inpatients grouped by their diagnoses category [Arm A, B, C, D - inpatients only] and for all participants [All in- and outpatients] at their last visit in 2015. The Arms A, B, C, D - inpatients only were mutually exclusive in 2015. Patients with risk factors (RF) 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.	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	The value of glycated hemoglobin (HbA1c) was calculated for inpatients grouped by their diagnoses category [Arm A, B, C, D - inpatients only] and for all participants [All in- and outpatients] at their last visit in 2017. The Arms A, B, C, D - inpatients only were mutually exclusive in 2017. Patients with risk factors (RF) 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.	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	The value of glycated hemoglobin (HbA1c) was calculated for inpatients grouped by their diagnoses category [Arm A, B, C, D - inpatients only] and for all participants [All in- and outpatients] at their last visit in 2019. The Arms A, B, C, D - inpatients only were mutually exclusive in 2019. Patients with risk factors (RF) 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.	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	The concentration (Millimole per liter (mmol/L)) of random blood glucose was calculated for inpatients grouped by their diagnoses category [Arm A, B, C, D - inpatients only] and for all participants [All in- and outpatients] at their last visit in 2015. The Arms A, B, C, D - inpatients only were mutually exclusive in 2015. Patients with risk factors (RF) 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.	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	The concentration (Millimole per liter (mmol/L)) of random blood glucose was calculated for inpatients grouped by their diagnoses category [Arm A, B, C, D - inpatients only] and for all participants [All in- and outpatients] at their last visit in 2017. The Arms A, B, C, D - inpatients only were mutually exclusive in 2017. Patients with risk factors (RF) 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.	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	The concentration (Millimole per liter (mmol/L)) of random blood glucose was calculated for inpatients grouped by their diagnoses category [Arm A, B, C, D - inpatients only] and for all participants [All in- and outpatients] at their last visit in 2019. The Arms A, B, C, D - inpatients only were mutually exclusive in 2019. Patients with risk factors (RF) 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.	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	Serum creatine concentration (μmol/L) was calculated for inpatients grouped by their diagnoses category [Arm A, B, C, D - inpatients only] and for all participants [All in- and outpatients] at their last visit in 2015. The Arms A, B, C, D - inpatients only were mutually exclusive in 2015. Patients with risk factors (RF) 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.	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	Serum creatine concentration (μmol/L) was calculated for inpatients grouped by their diagnoses category [Arm A, B, C, D - inpatients only] and for all participants [All in- and outpatients] at their last visit in 2017. The Arms A, B, C, D - inpatients only were mutually exclusive in 2017. Patients with risk factors (RF) 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.	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	Serum creatine concentration (μmol/L) was calculated for inpatients grouped by their diagnoses category [Arm A, B, C, D - inpatients only] and for all participants [All in- and outpatients] at their last visit in 2019. The Arms A, B, C, D - inpatients only were mutually exclusive in 2019. Patients with risk factors (RF) 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.	Last visit in 2019, up to 1 day

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim
• Collaborators: Chengdu Big Data Association

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2021
• Primary Completion (Actual): June 24, 2022
• Study Completion (Actual): June 24, 2022

Study Registration Dates

• First Submitted: May 25, 2021
• First Submitted That Met QC Criteria: May 25, 2021
• First Posted (Actual): May 26, 2021

Study Record Updates

• Last Update Posted (Estimated): November 12, 2024
• Last Update Submitted That Met QC Criteria: September 9, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 1245-0203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No