NCT05389254

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Ningbo No. 1 Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 2 Diabetes Mellitus
• Acute Coronary Syndrome

Interventions

Type	Name	Description
DEVICE	continuous glucose monitoring system	use real-time CGM system to check and adjust blood glucose
DEVICE	capillary blood glucose monitoring	monitor blood glucose with finger blood; real-time CGM is blind to both participants and researchers

Timeline

• Start date: 2022-06-01
• Primary completion: 2023-06-01
• Completion: 2023-12-01
• First posted: 2022-05-25
• Last updated: 2022-05-25

Locations

1 site across 1 country: China