UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041903 |
|---|---|
| Receipt number | R000047829 |
| Scientific Title | The study of the effect of frequent measurement of diabetes-related biomarkers in tears |
| Date of disclosure of the study information | 2020/09/29 |
| Last modified on | 2024/03/31 22:11:44 |
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Basic information
Public title
The study of the effect of frequent measurement of diabetes-related biomarkers in tears
Acronym
The study of the effect of frequent measurement of diabetes-related biomarkers in tears
Scientific Title
The study of the effect of frequent measurement of diabetes-related biomarkers in tears
Scientific Title:Acronym
The study of the effect of frequent measurement of diabetes-related biomarkers in tears
Region
| Japan |
Condition
Condition
diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to examine whether frequent measurement of diabetes-related biomarkers in tears affects behavioral changes and glycemic control.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HbA1c levels, glycoalbumin levels, fasting glucose levels
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Frequent measurement of diabetes-related biomarkers in tears and participants know the result
Interventions/Control_2
Frequent measurement of diabetes-related biomarkers in tears and participants know the result on the last day
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
Type 2 diabetes patients with HbA1c more than 6% and less than 9%
Key exclusion criteria
Participants who use insulin and GLP-1
Participants positive for HIV, hepatitis C, syphilis
Participants determined to be difficult to continue the study by doctors
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Naoto |
| Middle name | |
| Last name | Kubota |
Organization
The University of Tokyo Hospital
Division name
Department of Diabetes and Metabolic Diseases
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
81-3-5800-8818
nkubota-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Masakazu |
| Middle name | |
| Last name | Aihara |
Organization
The University of Tokyo
Division name
Department of Diabetes and Metabolic Diseases
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
81-3-5800-8818
Homepage URL
maihara-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The University of Tokyo Hospital
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
Tel
03-5841-3600
ethics@m.u-tokyo.ac.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
| 2020 | Year | 09 | Month | 29 | 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
| 2020 | Year | 09 | Month | 04 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 04 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 29 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 09 | Month | 27 | Day |
Last modified on
| 2024 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047829
