Comparative study between effects of insulin degludec and glargine U300 on nighttime blood glucose fluctuation -Investigasion using flash glucose monitoring system
Phase 4
- Conditions
- diabetes mellitus
- Registration Number
- JPRN-UMIN000026829
- Lead Sponsor
- Fukuiken Saisekai Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Not provided
Exclusion Criteria
1 Patients with a clear history of ischemic heart disease (angina, myocardial infarction), ischemic cerebrovascular disease 2 Patients with HbA1c fluctuating by 2% or more within 3 months 3 Severe ketosis, diabetic coma or prematurity 4 Patients with severe infection, preoperative, severe trauma 5 Cases judged by other physicians to be ineligible
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method For the first 5 days and last 5 days in the midnight to 6AM time zone 1 mean blood sugar level 2 Standard Deviation 3 Mean amplitude of glucose excursion
- Secondary Outcome Measures
Name Time Method For the first 5 days and last 5 days in the midnight to 6 AM time zone 1 Percentage of time zone with blood glucose level less than 70 mg per dl and its AUC 2 Percentage of time zone with blood sugar level less than 50 mg per dl and its AUC 3 Percentage of time zone with blood glucose level 140 mg per dl and its AUC