Effect of Patient Management Based on Continuous Continuous Glucose Monitoring on Major Adverse Cardiovascular Events in Patients With Type 2 Diabetes and Moderate to Severe Coronary Artery Stenosis

Not Applicable

Not yet recruiting

• Conditions: Major Adverse Cardiac Events; Diabetes Mellitus, Type 2
• Interventions: Device: CGM

• Registration Number: NCT06060483
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary

Patients with type 2 diabetes and moderate to severe coronary artery stenosis who were treated at Zhejiang Second Hospital and cooperative hospitals were randomly divided into a patient management group based on continuous continuous glucose monitoring (CGM) or a patient management group based on HbA1c. Both groups controlled cardiovascular risk factors according to the Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes (2020) and the ADA Guidelines for the Prevention and Treatment of Diabetes (2023), and conducted HbA1c testing every 3 months. In the CGM-based glucose management group, CGM measurements will be performed at baseline and at 6, 12, 18, and 24 months. In the CGM-guided treatment group, the target TIR\>70%, TBR\<4%, TAR\<25%, and HbA1c\<7.0%; in the HbA1c-guided treatment group, the target HbA1c\<7.0%. The primary endpoint was major adverse cardiovascular events (MACE: CV death, nonfatal myocardial infarction, nonfatal stroke).

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-09
• Study First Submitted: 2023-09-23
• Study First Submitted QC: 2023-09-23
• Last Update Submitted: 2023-09-23
• Study First Posted: 2023-09-29
• Last Update Posted: 2023-09-29
• Study Start: 2024-01
• Primary Completion: 2025-12
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 4000

Inclusion Criteria

Male or female between 35 and 75 years old type 2 diabetes HbA1C: 7.5%-10% Moderate to severe coronary artery stenosis (the degree of stenosis of any major coronary artery is ≥50% as assessed by coronary angiography or coronary CTA) The blood sugar lowering regimen has been stable in the past 3 months Ability to understand the requirements of the study and provide informed consent

Exclusion Criteria

Type 1 diabetes or other types of diabetes Acute myocardial infarction or stroke within the past three months Ketoacidosis, hyperosmolar hyperglycemic state Relative or absolute contraindications to contrast agent examinations such as severe renal insufficiency, contrast agent allergy, and hyperthyroidism Elective surgery planned within 2 years Preparing for pregnancy or becoming pregnant Life expectancy less than 2 years Skin allergies and other situations where CGM cannot be used Currently participating in other clinical studies

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CGM group	CGM	Wear CGM continuously and manage patients based on CGM. The treatment goals are TIR\>70%, TBR\<4%, TAR\<25%, and HbA1c\<7.0%. After the treatment reaches the standard, CGM is worn every six months.

Primary Outcome Measures

Name	Time	Method
major adverse cardiovascular events	2 years

Trial Locations

Locations (1)

the Second Affiliated Hospital Zhejiang University Schoolof Medicine; 🇨🇳 Hangzhou, China