Study on Appropriate Technology of Standardized Diagnosis and Treatment for Diabetic Patients With Pulmonary Infections

Shanghai Jiao Tong University

Status: Unknown

Conditions: Diabetes Mellitus; Pulmonary Infection

Study type: Observational

Funder types: Other

Identifiers

NCT03617393

2017YFC1309700

Details and patient eligibility

About

Focusing on patients with diabetes complicated with pulmonary infection, the purpose of this study is: 1) to identify the epidemiology, etiologic spectrum and status of diagnosis and treatment; 2) to develop a symptom score scale , clarify the risk factors and create a precise warning model; 3) to develop a rapid detection of pathogen of lower respiratory infection, to establish clinical pathways of early diagnosis and treatment of diabetes complicated with pulmonary infections (including bacterial, tuberculosis and fungal infections) and then make an application in clinic.

Full description

Investigators perform a observational study on 6000 patients with diabetes, among which 200 patients with pulmonary infection are included in a retrospective study and 100 patients go through metabolomics research. All patients receive clinical questionnaires, laboratory examinations and pulmonary function tests. Investigators study on pathogen distribution and infection ratio of patients above depending on follow-up survey. 1:1 nested case-control study is carried out involving 100 cases from pulmonary-infected group paired with 100 control cases matched for gender, age and fasting blood-glucose. The final purpose is to create a precise warning model in order to develop a rapid detection of pathogen of lower respiratory infection in diabetes patients. Now investigators wish to register this study to do a further research, in order to improve the early diagnosis of diabetes complicated with pulmonary infection and to reduce the mortality.

Enrollment: 6,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis by pathogen examination: positive
• Diagnosis through X-ray or CT: characteristic features of pulmonary infection
• Diagnosis through guideline of diabetes or history of diagnosed diabetes
• Age 40-70 years

Exclusion criteria

• Irregular follow-up and lost follow-up
• Withdraw from the study for any reason

Trial design

6,000 participants in 4 patient groups

Pulmonary Infection with DM group

Description:

Patients with diabetes and pulmonary infection.

Pulmonary Infection group

Description:

Patients with pulmonary infection while the fasting blood-glucose in the normal range.

DM group

Description:

Patients without pulmonary infection while the fasting blood-glucose \> 8 mmol/L.

Control group: normal people

Description:

Patients without pulmonary infection while the fasting blood-glucose in the normal range.