Change in variability of glucose daily profile by switching insulin Glargine to insulin Ddegludec in patients with diabetes -prospective open-label observational trial
Phase 4
- Conditions
- type1 or type2 diabetes mellitus
- Registration Number
- JPRN-UMIN000010148
- Lead Sponsor
- Hokkaido University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 22
Inclusion Criteria
Not provided
Exclusion Criteria
1) patients with unstable diabetic retinopathy, 2) severe hepatic dysfunction, renal dysfunction, heart failure, 3) history of anaphylaxis of insulin Degludec or insulin Glargine, 4) pregnancy, 5) patients who are inadequate to enter this study due to the other reasons by physician's judgments
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Variability of glucose daily profile (MAGE) using Continuous Glucose Monitoring System
- Secondary Outcome Measures
Name Time Method 1) hypo- and hyper- glycemic area of glucose daily profile using Continuous Glucose Monitoring System (AUCglucose24h, AUCglucose0-6am, AUCglucose24h of less than70mg/dl, AUCglucose0-6am of less than 70mg/dl), 2) change of insulin dose, 3) Frequency of hypoglycemia (awareness and unawareness), 4) levels of insulin antibody