Exploratory study to confirm correlation between device measurements and blood glucose levels
- Conditions
- ot applicable
- Registration Number
- JPRN-UMIN000047333
- Lead Sponsor
- Suntory Global Innovation Center Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 24
Not provided
(1) Systolic pressure <90 mmHg (2) Subjects who are pregnant or lactating. (3) Subjects who donated over 200ml blood components or whole blood within the past 4 weeks prior to the current study. (4) Male Subjects who donated over 400ml whole blood within the past 12 weeks prior to the current study. (5) Female who donated over 400ml whole blood within the past 16 weeks prior to the current study. (6) Male subjects whose blood was collected more than 1200 mL within the last twelve months when the amount of blood sampling in the current study is added. (7) Female subjects whose blood was collected more than 800 mL within the last twelve months when the amount of blood sampling in the current study is added. (8) Subjects who are participating in other clinical studies, or who finished clinical study within the last 4 weeks. (9) a) Subjects with disease on heart, liver, kidney or other organs complications. b) Subjects with a previous history of disease on circulatory organs. c) Subjects who are contracting diabetes. (10) Subjects who receive any kind of treatment at the time of study entry (11) Subjects with gastrointestinal diseases and/or a history of surgery affecting digestion and absorption (12) Subjects with alcohol sensitivity (13) Subjects with a previous history of feeling sick after blood sampling. (14) Subjects who have had an abnormal ECG (arrhythmia) indicated in the past. (15) Subjects with metal and/or latex allergic contact dermatitis (16) Subjects with allergies to food offered in the test. (17) Subjects who are constantly taking certain drug medicine, (18) Subjects who drink alcohol a lot (19) Subjects who work irregular shifts or at midnight. (20) Subjects who are judged as unsuitable for the study by the principal investigator for other reasons.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The correlation between the measurements obtained by the device and blood glucose levels
- Secondary Outcome Measures
Name Time Method