None listed
Conditions
Interventions
None listed
Sponsors
Suntory Global Innovation Center Ltd.
Macromill, Inc. Healthcare Systems Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Healthy male and female whose ages are 20 to <65 years old. (2) Subjects whose serum glucose level are < 126 mg/dL. (3) Subjects whose BMI are 18.5 to <30 kg/m2. (4) Subjects who agree with the given description and express informed consent via telecommunication and written documents.
Exclusion criteria
Exclusion criteria: (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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Accuracy of device measurements compared to reference blood glucose values | — |
Countries
Japan
Contacts
Public ContactTomoki Uchida
Suntory Global Innovation Center Ltd. Research Institute
Outcome results
None listed