Two-way crossover comparison of insulin glargine and insulin degludec in basal-bolus therapy using continuous glucose monitoring.
Not Applicable
- Conditions
- type 1 diabetes or type 2 diabetes
- Registration Number
- JPRN-UMIN000013285
- Lead Sponsor
- Kitasato University Kitasato Institute 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
Patients with diabetic nephropathy more than stage 3 (urinary albumin 300mg/gCr or urinary protein 0.5g/gCr) or with abnormal aspartate aminotransferase/alanine aminotransferase elevation (3 X the upper limit of normal) were excluded from this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Glycemic control is estimated as the mean blood glucose (MBG), the area under the glucose curve above 10.0 mmol/L (area under the curve [AUC]>10), and the percentage of time above 10.0mmol/L (t>10). The AUC is calculated using the trapezoidal method. Intraday glycemic variability is assessed as the standard deviation (SD) and the mean amplitude of glycemic excursions (MAGE). Day-to-day glycemic variability is assessed as the mean of daily difference (MODD). Hypoglycemia, which is defined as a sensor value of <3.9 mmol/L, was also calculated as a total time at <3.9 mmol/L. Severe hypoglycemia is defined as a sensor value of <2.8 mmol/L.
- Secondary Outcome Measures
Name Time Method