UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049107 |
|---|---|
| Receipt number | R000055945 |
| Scientific Title | Data acquisition and accuracy confirmation test for device measurements, fingertip blood glucose levels, and venous blood glucose levels |
| Date of disclosure of the study information | 2022/10/07 |
| Last modified on | 2022/10/04 10:06:35 |
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Basic information
Public title
Data acquisition and accuracy confirmation test for device measurements, fingertip blood glucose levels, and venous blood glucose levels
Acronym
Data acquisition and accuracy confirmation test for device measurements, fingertip blood glucose levels, and venous blood glucose levels
Scientific Title
Data acquisition and accuracy confirmation test for device measurements, fingertip blood glucose levels, and venous blood glucose levels
Scientific Title:Acronym
Data acquisition and accuracy confirmation test for device measurements, fingertip blood glucose levels, and venous blood glucose levels
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective is to acquire device measurements and blood glucose levels and to confirm the accuracy.
Basic objectives2
Others
Basic objectives -Others
Accuracy of device measurements compared to reference blood glucose values
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Accuracy of device measurements compared to reference blood glucose values
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key 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.
Key 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.
Target sample size
112
Research contact person
Name of lead principal investigator
| 1st name | Mitsuhiro |
| Middle name | |
| Last name | Zeida |
Organization
Suntory Global Innovation Center Ltd.
Division name
Research Institute
Zip code
6190284
Address
8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL
080-2546-4385
Mitsuhiro_Zeida@suntory.co.jp
Public contact
Name of contact person
| 1st name | Tomoki |
| Middle name | |
| Last name | Uchida |
Organization
Suntory Global Innovation Center Ltd.
Division name
Research Institute
Zip code
6190284
Address
8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL
050-3182-0381
Homepage URL
Tomoki_Uchida@suntory.co.jp
Sponsor or person
Institute
Suntory Global Innovation Center Ltd.
Institute
Department
Personal name
Funding Source
Organization
Suntory Global Innovation Center Ltd.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Macromill, Inc.
Healthcare Systems Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Healthcare Systems Co., Ltd.
Address
1-14-18 Shirakane, Showa-ku, Nagoya city, Aichi, JAPAN
Tel
052-734-8885
soumu@hc-sys.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 10 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2022 | Year | 09 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 10 | Month | 08 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational, single-center, open-label study
Management information
Registered date
| 2022 | Year | 10 | Month | 04 | Day |
Last modified on
| 2022 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055945
