Validation of non-invasive blood glucose measurement
- Conditions
- Diabetes (Type 1,2)Diabetes
- Registration Number
- JPRN-jRCTs032220521
- Lead Sponsor
- ishimura Rimei
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 410
Inpatients who meet all of the following selection criteria will be eligible for the study and whose consent has been obtained
1.Patients who are able to have at least 5 blood samples taken and blood glucose level measured by the test device.
2. Age Patients who are at least 18 years old at the time consent is obtained.
3. Gender Any gender
4. Patients who have been fully informed of the study and who have given written consent of their own free will.
5. Patients who possess SMBG equipment (SMBG capable of acquiring data up to 15 times every 10 minutes) or wear CGM equipment (FreestyleLibre) (Measurement B only)
Patients who meet at least one of the following exclusion criteria will be excluded.
(1) Patients who require immediate treatment due to changes in blood glucose levels
(2) Patients who are judged by the principal investigator (subinvestigator) to be inappropriate to participate in this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Difference between blood glucose level in venous blood and blood glucose level estimated from test equipment
- Secondary Outcome Measures
Name Time Method Difference between the range of change in venous blood glucose or SMBG and CGM measurements and the range of change in blood glucose estimated from non-invasive devices, and the number of successful measurements/number of measurements of blood glucose estimated from non-invasive devices