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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

NCT ID: NCT06060483

Last Updated: 2023-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

4000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-31

Study Completion Date

2026-01-31

Brief Summary

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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

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Conditions

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Diabetes Mellitus, Type 2 Major Adverse Cardiac Events

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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CGM group

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.

Group Type EXPERIMENTAL

CGM

Intervention Type 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.

HbA1c group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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zhengchao

Professor Zhengchao

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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the Second Affiliated Hospital Zhejiang University Schoolof Medicine

Hangzhou, , China

Site Status

Countries

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China

Other Identifiers

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CGM-MACE

Identifier Type: -

Identifier Source: org_study_id