Data acquisition and accuracy confirmation test for device measurements, fingertip blood glucose levels, and venous blood glucose levels
- Conditions
- ot applicable
- Registration Number
- JPRN-UMIN000049107
- Lead Sponsor
- Suntory Global Innovation Center Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 112
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 with gastrointestinal diseases and/or a history of surgery affecting digestion and absorption (11) Subjects with alcohol sensitivity (12) Subjects with a previous history of feeling sick after blood sampling. (13) Subjects with metal and/or latex allergic contact dermatitis (14) Subjects with allergies to glucose tolerance. (15) Subjects who have had an abnormal ECG (arrhythmia) indicated in the past. (16) Subjects who wear false nails, and those whose white part of the tip of the nail is extended by 3 mm or more. (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 Accuracy of device measurements compared to reference blood glucose values
- Secondary Outcome Measures
Name Time Method