An interventional study of CGM in Diabetes Mellitus, Type 2 and Major Adverse Cardiac Events, sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine. Status unknown at 1 site in China. Open to participants aged 35 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-09-29.
Sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine · Not applicable, Interventional, and Prevention
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).
9,590 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.
This study's planned enrollment of 4,000 is above the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Second Affiliated Hospital, Zhejiang University, School of Medicine is the lead sponsor of 90 studies on the registry; 60 are open to participants now.
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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
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 testing is performed every three months, patient management is based on HbA1c, and the treatment target is HbA1c \<7.0%.
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.
major adverse cardiovascular events
Time frame: 2 years
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Second Affiliated Hospital, Zhejiang University, School of Medicine