Unique ID issued by UMIN | UMIN000047333 |
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Receipt number | R000053983 |
Scientific Title | Exploratory study to confirm correlation between device measurements and blood glucose levels |
Date of disclosure of the study information | 2022/04/06 |
Last modified on | 2022/06/29 20:37:15 |
Exploratory study to confirm correlation between device measurements and blood glucose levels
Exploratory study to confirm correlation between device measurements and blood glucose levels
Exploratory study to confirm correlation between device measurements and blood glucose levels
Exploratory study to confirm correlation between device measurements and blood glucose levels
Japan |
Not applicable
Not applicable |
Others
NO
The objective is to confirm the correlation between the measurements obtained by the device and blood glucose levels.
Others
The correlation between the measurements obtained by the device and blood glucose levels
The correlation between the measurements obtained by the device and blood glucose levels
Observational
20 | years-old | <= |
65 | years-old | > |
Male and Female
(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.
(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.
24
1st name | Mitsuhiro |
Middle name | |
Last name | Zeida |
Suntory Global Innovation Center Ltd.
Research Institute
619-0284
8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
080-2546-4385
Mitsuhiro_Zeida@suntory.co.jp
1st name | Tomoki |
Middle name | |
Last name | Uchida |
Suntory Global Innovation Center Ltd.
Research Institute
619-0284
8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
05031820381
Tomoki_Uchida@suntory.co.jp
Suntory Global Innovation Center Ltd.
None
Other
Chiyoda Paramedical Care Clinic Clinical Trial Review Committee
3-1-15, Nihonbashihongokucho, Chuo-ku, Tokyo, 103-0021 Japan
03-6225-9005
IRB@cpcc.cp.jp
NO
2022 | Year | 04 | Month | 06 | Day |
Unpublished
Completed
2022 | Year | 03 | Month | 25 | Day |
2022 | Year | 03 | Month | 25 | Day |
2022 | Year | 04 | Month | 08 | Day |
2022 | Year | 05 | Month | 14 | Day |
Observational, single-center, open-label study
2022 | Year | 03 | Month | 30 | Day |
2022 | Year | 06 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053983
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