Open AccessThe 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 (OPTIMAL)
Author(s) -
Yasufumi Kataoka,
Kiminori Hosoda,
Hisashi Makino,
Masaki Matsubara,
Miki Matsuo,
Yoko Ohata,
Ryo Koezuka,
Tamiko Tamanaha,
Tsutomu Tomita,
Kyoko Honda-Kohmo,
Michio Noguchi,
Cheol Son,
Kunihiro Nishimura,
Yasuhide Asaumi,
Yoshihiro Miyamoto,
Teruo Noguchi,
Satoshi Yasuda
Publication year - 2019
Publication title -
cardiovascular diagnosis and therapy
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.83
H-Index - 22
eISSN - 2223-3660
pISSN - 2223-3652
DOI - 10.21037/cdt.2019.09.02
Subject(s) - medicine , glycemic , atheroma , diabetes mellitus , clinical endpoint , coronary artery disease , cardiology , type 2 diabetes mellitus , hypoglycemia , clinical trial , randomized controlled trial , type 2 diabetes , endocrinology
Patients with type 2 diabetes mellitus (T2DM) are high-risk subjects who more frequently have micro- and macrovascular diseases including coronary artery disease (CAD). Since impaired glycemic homeostasis directly influences the formation and propagation of atherosclerotic plaques, optimal management of glycemic status is required for the prevention of diabetic atherosclerosis. Continuous glucose monitoring (CGM) provides not only average glucose level but also the degree of glucose fluctuation and hypoglycemia. Given the association of glycemic variability with diabetic macrovascular diseases, CGM-based glycemic management could favorably modulate glycemic fluctuation, thereby potentially modifying atheroma burden in T2DM subjects. To test this hypothesis, the Observation of Coronary Atheroma Progression under Continuous Glucose Monitoring Guidance in Patients with Type 2 Diabetes Mellitus (OPTIMAL) study has been designed (Japan Registry of Clinical Trials: jRCT1052180152, University Hospital Medical Information Network Clinical Trial Registry UMIN000036721).