A prospective observational study to investigate the relationship between glucose fluctuation and a subsequent incidence of cardiovascular events in patients with type 2 diabetes
- Conditions
- type 2 diabetes
- Registration Number
- JPRN-UMIN000032325
- Lead Sponsor
- Juntendo University Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 1000
Not provided
1)patients with type 1 or secondary diabetes 2)presence of severe infectious disease, before or after surgery, or severe trauma, 3)history of myocardial infarction, angina pectoris, cerebral stroke, or cerebral infarction, or arteriosclerosis obliterans4)patients undergoing artificial dialysis5)moderate liver dysfunction (aspartate aminotransferase 100 IU/l or more) 6)moderate or severe heart failure (NYHA/New York Heart Association stage III or severer) 7)patients with pregnant, lactating, or possibly pregnant women, or those planning to become pregnant during the study period 8) Present or past history of a malignant tumor (exception: those not on medication for malignant tumor and with no recurrence of the disease to date and without recurrence risks during this study were allowed to participate.) 9) patients with use of Sensor Augmented Pump 10) patients judged as ineligible by the clinical investigators.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary study outcome is to investigate the relationships between fluctuations in glucose levels evaluated by continuous glucose monitoring and the incidence of composite cardiovascular events including cardiovascular death, acute myocardial infarction, unstable angina pectoris, revascularization for the treatment of coronary artery diseases, ischemic stroke, or revascularization for the treatment of arteriosclerosis obliterans.
- Secondary Outcome Measures
Name Time Method