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
調査の概要
状態
条件
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Chengdu、中国、610041
- Chengdu Big Data Association
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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)
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
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Group A: Diabetic patients with CVD, CKD or at risk
The group A includes all Patients with diagnosis of diabetes, and with diagnosis of cardiovascular disease, heart failure, chronic kidney disease or at high cardiovascular risk.
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Group B: Diabetic patients without CVD, CKD or at risk
The group B includes all patients with diagnosis of diabetes, but not with diagnosis of cardiovascular disease, heart failure, chronic kidney disease or at high cardiovascular risk.
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Group C: Non-diabetic patients with CVD, CKD or at risk
The group C includes all patients with diagnosis of cardiovascular disease, heart failure, chronic kidney disease or at high cardiovascular risk, but not with diagnosis of diabetes.
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Group D: Non-diabetic patients without CVD, CKD or at risk
The group D includes all patients without diagnosis of cardiovascular disease, heart failure, chronic kidney disease or at high cardiovascular risk, and without diagnosis of diabetes.
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
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The proportion of diabetic/non-diabetic patients with established cardiovascular disease, or chronic kidney disease, or at high cardiovascular risk
時間枠:up to 4 years
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up to 4 years
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The proportion of diabetic patients with established cardiovascular disease, or chronic kidney disease, or at high cardiovascular risk among all diabetic patients
時間枠:up to 4 years
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up to 4 years
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The proportion of non-diabetic patients with established cardiovascular disease, or chronic kidney disease, or at high cardiovascular risk among all non-diabetic patients
時間枠:up to 4 years
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up to 4 years
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二次結果の測定
結果測定 |
時間枠 |
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Age at admission at the latest visit for all patients, as well as the trends for inpatients over time (2015, 2017, and 2019 respectively)
時間枠:up to 4 years
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up to 4 years
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Gender at the latest visit for all patients, as well as the trends for inpatients over time (2015, 2017, and 2019 respectively)
時間枠:up to 4 years
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up to 4 years
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Insurance payment at the latest visit for all patients, as well as the trends for inpatients over time (2015, 2017, and 2019 respectively)
時間枠:up to 4 years
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up to 4 years
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Discharge department at the latest visit for all patients, as well as the trends for inpatients over time (2015, 2017 and 2019 respectively)
時間枠:up to 4 years
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up to 4 years
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Proportion of death at the latest visit for all patients, as well as the trends for inpatients over time (2015, 2017 and 2019 respectively)
時間枠:up to 4 years
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up to 4 years
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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)
時間枠:up to 4 years
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up to 4 years
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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)
時間枠:up to 4 years
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up to 4 years
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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)
時間枠:up to 4 years
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up to 4 years
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協力者と研究者
出版物と役立つリンク
便利なリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 1245-0203
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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).
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