UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053471 |
|---|---|
| Receipt number | R000061008 |
| Scientific Title | Evaluation of the prototype device for glucose monitoring by oral glucose tolerance test |
| Date of disclosure of the study information | 2024/01/30 |
| Last modified on | 2024/03/21 08:43:59 |
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Basic information
Public title
Evaluation of the prototype device for glucose monitoring by oral glucose tolerance test
Acronym
Evaluation of the prototype device for glucose monitoring by oral glucose tolerance test
Scientific Title
Evaluation of the prototype device for glucose monitoring by oral glucose tolerance test
Scientific Title:Acronym
Evaluation of the prototype device for glucose monitoring by oral glucose tolerance test
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm accuracy and characteristics of the blood glucose monitoring device, which is under development, by comparing the data from gold-standard or the date from current simplified glucose monitoring methods.
Basic objectives2
Others
Basic objectives -Others
Correlation between the prototype device and the following blood glucose levels
1.Blood glucose level by venous blood collection
2.Blood glucose level by continuous glucose monitoring.
3.Blood glucose level by self-blood collection (fingertip)
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of glucose level for each of the prototype devices and venous blood sampling, fingertip sampling and continuous glucose monitoring.
Key secondary outcomes
None
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Oral glucose(device)
Interventions/Control_2
Oral glucose(continuous glucose monitoring)
Interventions/Control_3
Oral glucose (fingertip sampling)
Interventions/Control_4
Oral glucose (venous blood collection)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Males and females aged 20 years or older at the time of informed consent.
2) Subjects who can make self-judgment and voluntarily gave written informed consent.
3) Subjects whose fasted blood glucose levels are 100 mg/dL or more and less than 126 mg/dL at a health checkup within the past year.
Key exclusion criteria
1)Subjects who are on treatment for a serious illness.
2)Subjects who have been diagnosed with diabetes and under treatment or medication.
3)Subjects who are may develop allergies in connection with the oral glucose tolerance test.
4)Subjects who regularly use licensed drugs or quasi-drugs that may affect the study.
5)Subjects who are currently on treatment at a medical institution for a disease that may affect the study.
6)Subjects who are participating in a clinical trial or have participated in another clinical trial within 1 month before the date of consent for this study.
7)Subjects who are pregnant and those who are breastfeeding.
8)Subjects who plan to participate in another clinical trial during the study period.
9)Subjects who have difficulty in wearing the prototype device.
10)Subjects who have difficulty in wearing continuous glucose monitoring.
11)Subjects who have difficulty in blood drawing from their fingertips by themselves.
12)Subjects who judged as unsuitable for this study by the principal investigator for any reasons.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Toshio |
| Middle name | |
| Last name | Miyata |
Organization
DEN Medical Corporation MIH Clinic Yoyogi.
Division name
Chairman of the board
Zip code
151-0051
Address
2F Value HR Building, 5-21-14 Sendagaya, Shibuya-ku, Tokyo
TEL
03-6276-5385
info@mih-clinic.com
Public contact
Name of contact person
| 1st name | Masako |
| Middle name | |
| Last name | Mizuuchi |
Organization
APO PLUS STATION CO., LTD
Division name
CRO Business division
Zip code
103-0027
Address
Front Place Nihonbashi,2-14-1 Nihonbashi, Chuo-ku, Tokyo
TEL
03-6386-8809
Homepage URL
food-contact@apoplus.co.jp
Sponsor or person
Institute
APO PLUS STATION CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
TANITA Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee, ITO Yoyogi Mental Clinic
Address
4-26-11 Sendagaya, Shibuya-ku, Tokyo
Tel
03-6804-2227
cns_jimu@triad-j.co.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
医療法人社団DENみいクリニック代々木(東京都）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | Month | 30 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 01 | Month | 15 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 15 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 30 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 01 | Month | 29 | Day |
Last modified on
| 2024 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061008
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
