The safety and accuracy test for wearing the continuous glucose monitoring sensor "Libre Pro" on the abdome
Not Applicable
- Conditions
- diabetes mellitus
- Registration Number
- JPRN-UMIN000032371
- Lead Sponsor
- St. Marianna University School of Medicine Toyoko Hospital, Lifestyle-related Disease Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
Not provided
Exclusion Criteria
Pregnancy and the patients who are decided by their attending physician that it is inappropriate to participate in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety assessment of Libre Pro sensor attached to the abdomen for 2 weeks by the following questions Q1. Whether there is a pain generated by skin puncture when the sensor is attached to the body Q2. Whether there is a bleeding or infection at the insertion site Q3. Whether there is a dermatitis on the site where the sensor attached Q4. Whether there is an uncomfortable wearing and its stress Q5. Whether there is difficulty in daily life due to wearing the sensor
- Secondary Outcome Measures
Name Time Method Assessment of the glucose measurement accuracy regarding Libre Pro sensor attached to the abdomen for 2 weeks by the following test 1. Correspondence of SG values between "Libre Pro" sensors at the arm and abdomen over a 2 week-period and Accuracy of these sensors against the calibrated conventional CGM sensor "iPro2" as reference 2. Ability of each CGM device and the glucose test strips to detect rapid fluctuation of venous plasma glucose (VPG) during an oral glucose tolerance test