type 2 diabetes
Conditions
Interventions
None listed
Sponsors
Juntendo University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)30 years of age or older and 80 years of age or younger(regardless of gender) 2)T2DM patients treated at the outpatient clinic. 3)signing consent form for participation in the study. 4)No changes (including new prescriptions) in their antidiabetic medication for at least 4 weeks before FreeStyle Libre Pro sensors were applied at the back of the upper arm of each participant.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 1) the relationships between fluctuations in glucose levels evaluated by continuous glucose monitoring and the incidence of composite cardiovascular events (a, b or c, or each of a,b and c) a)heart diseases (cardiovascular death, acute myocardial infarction, unstable angina pectoris, revascularization for the treatment of coronary artery diseases or hospitalization for heart failure) b)cerebrovascular diseases (ischemic stroke, hemorrhagic stroke or subarachnoid haemorrhage) c)artery diseases (arteriosclerosis obliterans, revascularization for the treatment of arteriosclerosis obliterans or lower limb amputation) 2) the relationships between fluctuations in glucose levels evaluated by continuous glucose monitoring and the incidence of malignant tumors, 3) the relationships between fluctuations in glucose levels evaluated by continuous glucose monitoring and all-cause mortality in addition to a) plus b) plus c) as described above. 4) the relationships between fluctuations in glucose levels evaluated by continuous glucose monitoring, and cardiovascular death, myocardial infarction or stroke. 5) the relationships between fluctuations in glucose levels evaluated by continuous glucose monitoring, and cardiovascular death, myocardial infarction, unstable angina, or stroke. 6) the relationships between fluctuations in glucose levels evaluated by continuous glucose monitoring, and development or progression of diabetic retinopathy or nephropathy. 7) the relationships between fluctuations in glucose levels evaluated by continuous glucose monitoring, and changes in mean carotid intima media thickness, max carotid intima media thickness, gray-scale median, or brachial-ankle pulse wave velocity. 8) the relationships between fluctuations in glucose levels evaluated by continuous glucose monitoring, and changes in Diabetes Therapy-Related QOL scores or Pittsburgh Sleep Quality Index scores. etc. | — |
Countries
Japan
Contacts
Public Contactohmura mita tomoya
Juntendo University Graduate School of Medicine Department of Metabolism & Endocrinology
Outcome results
None listed