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

NCT06060483 | Unknown

• 1 other identifier: CGM-MACE
• Study Type: interventional
• Target: 4,000
• Locations: 1 country
• Sites: 1

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).

Conditions

Diabetes Mellitus, Type 2; Major Adverse Cardiac Events

Outcome Measures

Primary Outcomes (1)

• major adverse cardiovascular events

  2 years

Study Arms (2)

CGM group

EXPERIMENTAL

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.

Device: CGM

HbA1c group

NO INTERVENTION

HbA1c testing is performed every three months, patient management is based on HbA1c, and the treatment target is HbA1c \<7.0%.

Interventions

CGM DEVICE

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.

CGM group

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

the Second Affiliated Hospital Zhejiang University Schoolof Medicine

Hangzhou, 310009, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Zhengchao

Study Record Dates

• First Submitted: September 23, 2023
• First Posted: September 29, 2023
• Study Start: January 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: September 29, 2023

Record last verified: 2023-09

Locations

CN (1)