Study S002738

The Efficacy of Glycemic Control With Continuous Glucose Monitoring on Atheroma Progression: Rationale and Design of the Observation of Coronary Atheroma Progression Under Continuous Glucose Monitoring Guidance in Patients With Type 2 Diabetes Mellitus

ClinicalTrials.gov record

Registration

Registration: NCT04559191
Acronym: OPTIMAL
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE4
Masking: NONE
Status: UNKNOWN
Enrollment: 90
Start: 2019-03-01
Primary completion: 2021-12-31
Lead sponsor: National Cerebral and Cardiovascular Center, Japan
Conditions: Coronary Atherosclerosis
Interventions: DEVICE:continuous glucose monitoring (CGM)
Results posted: FALSE
Individual participant data sharing: UNDECIDED

Registered primary outcomes

the normalized absolute change in total atheroma volume on serial intravascular ultrasound imaging. [from baseline to 12 months]

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