Effect of Insulin Degludec versus twice-daily administration of basal insulin in type 1 diabetes assessed by continuous glucose monitoring system
Not Applicable
- Conditions
- twice-daily administration of basal insulin in type 1 diabetes
- Registration Number
- JPRN-UMIN000010474
- Lead Sponsor
- Juntendo University Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
Not provided
Exclusion Criteria
1.Patients with past medical history of hypersensitivity to Degludec. 2.Patients with serious liver,renal,pituitary and adrenal insufficiency. 3.Patients with diarrhea, vomiting and other gastrointestinal problems. 4.Patients with starvation state or unstable appetite. 5.Patients with serious diabetic complications including proliferative retinopathy. 6.Patients who are pregnant, hope to be pregnant, or are in lactation period. 7.Judged as ineligible by clinical investigators 8.Patients with type 1 diabetes
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change of HbA1c level of the two treatment
- Secondary Outcome Measures
Name Time Method The difference between treatments in following parameters: fasting plasma glucose (FPG), variability (standard deviation) and intra individual variability of 7-point capillary blood glucose profile value measured by SMBG, variability of the two treatments by the continuous glucose monitoring system(Medtronic), frequency and severity of hypoglycemic episodes