N/A
N=398,008
Clinical Characteristics and Disease Burden of Diabetic Patients Based on Tianjin Regional Database
Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT04903496 ↗Enrolled (actual)
398,008
Serious AEs
—
Results posted
Nov 2024
Primary outcome: Primary: Number of Participants With Established Cardiovascular Disease, or Chronic Kidney Disease, or High Cardiovascular Risk — 127726; 43819; 295882; 99128 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Established Cardiovascular Disease, or Chronic Kidney Disease, or High Cardiovascular Risk |
127726; 43819; 295882; 99128; 448063; 138069 | — |
| SECONDARY Mean Age of Inpatients and All Participants (In-and Outpatients) at Their Last Visit in 2015 |
64.1; 49.7; 64.8; 61.9; 60.1 | — |
| SECONDARY Mean Age of Inpatients and All Participants (In-and Outpatients) at Their Last Visit in 2017 |
63.0; 44.2; 62.7; 62.1; 59.3 | — |
| SECONDARY Mean Age of Inpatients and All Participants (In-and Outpatients) at Their Last Visit in 2019 |
61.8; 46.3; 63.0; 62.5; 58.9 | — |
| SECONDARY Number of Female and Male Inpatients and All Participants (In-and Outpatients) at Their Last Visit in 2015 |
42775; 7683; 11709; 2761; 195654; 41825 | — |
| SECONDARY Number of Female and Male Inpatients and All Participants (In-and Outpatients) at Their Last Visit in 2017 |
54221; 14543; 13939; 3789; 287609; 62578 | — |
| SECONDARY Number of Female and Male Inpatients and All Participants (In-and Outpatients) at Their Last Visit in 2019 |
63480; 14309; 14894; 3865; 335474; 76055 | — |
| SECONDARY Number of Inpatients and All Participants (In-and Outpatients) With Insurance Payment at Their Last Visit in 2015 |
57950; 8489; 13797; 3760; 340909 | — |
| SECONDARY Number of Inpatients and All Participants (In-and Outpatients) With Insurance Payment at Their Last Visit in 2017 |
77385; 12792; 16484; 4467; 482628 | — |
| SECONDARY Number of Inpatients and All Participants (In-and Outpatients) With Insurance Payment at Their Last Visit in 2019 |
94453; 13508; 18762; 5167; 543328 | — |
| SECONDARY Number of Inpatients and All Participants (In-and Outpatients) by Discharge Department at Their Last Visit in 2015 |
210; 19; 66; 2; 417; 933 | — |
| SECONDARY Number of Inpatients and All Participants (In-and Outpatients) by Discharge Department at Their Last Visit in 2017 |
35; 136; 13; 5; 422; 2071 | — |
| SECONDARY Number of Inpatients and All Participants (In-and Outpatients) by Discharge Department at Their Last Visit in 2019 |
50; 229; 13; 8; 704; 2428 | — |
| SECONDARY Number of Deaths in Inpatients and All Participants (In-and Outpatients) at Their Last Visit in 2015 |
303; 18; 94; 15; 430 | — |
| SECONDARY Number of Deaths in Inpatients and All Participants (In-and Outpatients) at Their Last Visit in 2017 |
504; 29; 141; 30; 704 | — |
| SECONDARY Number of Deaths in Inpatients and All Participants (In-and Outpatients) at Their Last Visit in 2019 |
225; 8; 41; 20; 294 | — |
| SECONDARY The Value of Glycated Hemoglobin (HbA1c) in Inpatients and in All Participants (in- and Outpatients) at Their Last Visit in 2015 |
7.8; 9.2; 5.7; 5.4; 6.9 | — |
| SECONDARY The Value of Glycated Hemoglobin (HbA1c) in Inpatients and in All Participants (in- and Outpatients) at Their Last Visit in 2017 |
7.6; 7.8; 5.8; 5.8; 7.2 | — |
| SECONDARY The Value of Glycated Hemoglobin (HbA1c) in Inpatients and in All Participants (in- and Outpatients) at Their Last Visit in 2019 |
7.7; 7.3; 5.8; 5.4; 7.1 | — |
| SECONDARY Concentration of Random Blood Glucose in Inpatients and in All Participants (in- and Outpatients) at Their Last Visit in 2015 |
8.3; 8.3; 5.3; 8.5; 8.3 | — |
| SECONDARY Concentration of Random Blood Glucose in Inpatients and in All Participants (in- and Outpatients) at Their Last Visit in 2017 |
9.4; 8.8; 5.3; 7.2; 8.5 | — |
| SECONDARY Concentration of Random Blood Glucose in Inpatients and in All Participants (in- and Outpatients) at Their Last Visit in 2019 |
9.0; 7.7; 5.3; 5.1; 8.3 | — |
| SECONDARY Serum Creatine Concentration in Inpatients and in All Participants (in- and Outpatients) at Their Last Visit in 2015 |
70.0; 56.0; 67.0; 62.3; 68.0 | — |
| SECONDARY Serum Creatine Concentration in Inpatients and in All Participants (in- and Outpatients) at Their Last Visit in 2017 |
69.2; 54.0; 68.0; 61.0; 67.0 | — |
| SECONDARY Serum Creatine Concentration in Inpatients and in All Participants (in- and Outpatients) at Their Last Visit in 2019 |
70.0; 53.5; 68.1; 62.0; 67.6 | — |
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
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;
- 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)
Data sourced from ClinicalTrials.gov (NCT04903496). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.