Association Between Time in Range and In-hospital Outcomes in Type 2 Diabetic Patients With Acute Coronary Syndrome

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Association Between Time in Range and In-hospital Outcomes in Type 2 Diabetes Mellitus Patients With Acute Coronary Syndrome

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05389254
• Other study ID #: 2022B034
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2022
• Est. completion date: December 2023

Study information

• Verified date: May 2022
• Source: Ningbo No. 1 Hospital
• Contact: Li Li, Bachelor
• Phone: 8613757426626
• Email: lilyningbo[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to use real-time continuous glucose monitoring (real-time CGM) system to get a 14-days blood glucose profile of the hospitalized type 2 diabetes mellitus (T2DM) patients with acute coronary syndrome (ACS), and to understand whether time in range (TIR) is associated with in-hospital outcomes of these patients. This study plans to recruit 100 patients. They will be randomly divided into 2 groups: real-time CGM group and capillary blood glucose monitoring group. All enrolled participants will receive standardized blood glucose management according to the "Expert consensus on blood glucose management of inpatients in China". The duration of the study will be 3 months. The primary endpoint is the average hospital stay and cardiac care unit (CCU) occupancy rate in T2DM patients with ACS. The secondary endpoint is a composite endpoint of nonfatal myocardial infarction, acute heart failure, heart failure rehospitalization, coronary revascularization, cardiovascular death, all-cause death.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• aged =18 and =70 years old;

• T2DM according to 2022 American Diabetes Association standards;

• Patients admitted to hospital with either non-ST elevation acute coronary syndrome or ST-elevation myocardial infarction; coronary angiography examination data can be collected;

• a stable glucose lowering regimen for the previous 3 months;

• obtain informed consent;

• with complete clinical data.

Exclusion Criteria:

• Diagnosis of other types of diabetes, such as type 1 diabetes, gestational diabetes, secondary diabetes, etc.;

• No acute complications of diabetes, such as ketoacidosis, nonketotic hyperosmolar coma, etc.;

• Repeated severe hypoglycemia or hyperglycemia in the past 3 months;

• Patients who have had a history of allergic reactions to CGM materials or skin adhesives, alcohol or chlorhexidine disinfectants;

• Patients who have symptoms and signs of skin lesions, scarring, redness, infection or edema at the sensor application site that can affect the accuracy of sensor application or interstitial fluid glucose measurements;

• Combined with other acute disease states, such as uncontrolled severe infection, use of catecholamines or sedatives, use of ventilator, ventricular fibrillation, etc.;

• Patients who have a history of hematocrit, platelet, and hemoglobin abnormalities within past 2 months; moderate to severe anemia; or a disease (such as a coagulation disorder) that increases the risk of bleeding;

• Patients with malignant tumors, severe liver and kidney diseases, allergic diseases, mental and neurological diseases, combined with rheumatic or immune diseases;

• Using drugs that may affect blood sugar, including steroids, psychotropic drugs, anti-AIDS drugs, etc.;

• X-ray, CT, MRI examinations are scheduled during the period of wearing the sensor, and the appointment time cannot be changed to the beginning or the end of wearing;

• Patients currently participate in another clinical trial;

• Unwilling or unwilling to comply with study requirements, poor compliance, or refusal to use real time-CGM.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Syndrome
• Type 2 Diabetes Mellitus

Intervention

Device:
• continuous glucose monitoring system
use real-time CGM system to check and adjust blood glucose
• capillary blood glucose monitoring
monitor blood glucose with finger blood; real-time CGM is blind to both participants and researchers

Locations

Country	Name	City	State
China	Ningbo First Hospital	Ningbo	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Ningbo No. 1 Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The average hospital stay	The average hospital stay in hospitalized T2DM patients with ACS.	3 months
Primary	The CCU occupancy rate	The CCU occupancy rate in in hospitalized T2DM patients with ACS.	3 months
Secondary	Major adverse cardiovascular events after 3 months	A composite endpoint of nonfatal myocardial infarction, acute heart failure, heart failure rehospitalization, coronary revascularization, cardiovascular death, all-cause death.	3 months