UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055748 |
|---|---|
| Receipt number | R000063504 |
| Scientific Title | The feasibility study on a postprandial blood glucose trend prediction model using FreeStyle Libre |
| Date of disclosure of the study information | 2024/10/07 |
| Last modified on | 2024/10/04 22:27:05 |
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Basic information
Public title
The feasibility study on a postprandial blood glucose trend prediction model using FreeStyle Libre
Acronym
The feasibility study on a postprandial blood glucose trend prediction model using FreeStyle Libre
Scientific Title
The feasibility study on a postprandial blood glucose trend prediction model using FreeStyle Libre
Scientific Title:Acronym
The feasibility study on a postprandial blood glucose trend prediction model using FreeStyle Libre
Region
| Japan |
Condition
Condition
Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The analysis of blood glucose data obtained using FreeStyle Libre, along with other acquired data, will be conducted to develop and improve the accuracy of a postprandial blood glucose trend prediction model.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change in blood glucose levels from the start to the end (56 days) .
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Japanese healthy males and females over 18 years old
Key exclusion criteria
1) Currently undergoing treatment for diabetes
2) Individuals deemed inappropriate by the principal investigato
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shohei |
| Middle name | |
| Last name | Tokunaga |
Organization
THE PHAGE, Inc.
Division name
NA
Zip code
150-0002
Address
5th Floor, Yamaguchi Building, 17-4 Shibuya 3-chome, Shibuya-ku, Tokyo, Japan
TEL
03-4500-1654
info@thephage.life
Public contact
Name of contact person
| 1st name | Tokunaga |
| Middle name | |
| Last name | Shohei |
Organization
THE PHAGE, Inc.
Division name
NA
Zip code
150-0002
Address
5th Floor, Yamaguchi Building, 17-4 Shibuya 3-chome, Shibuya-ku, Tokyo, Japan
TEL
03-4500-1654
Homepage URL
info@thephage.life
Sponsor or person
Institute
other
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
THE PHAGE, Inc.
Address
5th Floor, Yamaguchi Building, 17-4 Shibuya 3-chome, Shibuya-ku, Tokyo, Japan
Tel
03-4500-1654
info@thephage.life
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
| 2024 | 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
100
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
Completed
Date of protocol fixation
| 2023 | Year | 11 | Month | 26 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 03 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 05 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
NA
Management information
Registered date
| 2024 | Year | 10 | Month | 04 | Day |
Last modified on
| 2024 | 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=R000063504
