UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044088 |
|---|---|
| Receipt number | R000050343 |
| Scientific Title | Cohort survey about meal, sleep, physical activity, actual treatment and quality of life on Japanese type 1 diabetes patients |
| Date of disclosure of the study information | 2021/05/01 |
| Last modified on | 2021/05/01 11:37:52 |
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Basic information
Public title
Cohort survey about meal, sleep, physical
activity, actual treatment and quality of
life on Japanese type 1 diabetes patients
Acronym
Cohort survey about meal, sleep, physical
activity, actual treatment and QOL on
Japanese type 1 diabetes patients
Scientific Title
Cohort survey about meal, sleep, physical
activity, actual treatment and quality of
life on Japanese type 1 diabetes patients
Scientific Title:Acronym
Cohort survey about meal, sleep, physical
activity, actual treatment and QOL on
Japanese type 1 diabetes patients
Region
| Japan |
Condition
Condition
Type 1 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This is a study to grasp the real life and
treatment of type 1 diabetes.
Basic objectives2
Others
Basic objectives -Others
This is a study to aim the improvement of
quality of life(QOL) for type 1 diabetes.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relation between the scores of
questionnaires(Problem Areas in Diabetes,
Beck Depression inventory2)and the
parameters
Key secondary outcomes
1)diabetes control
2)lipid control
3)meal pattern
4)sleep pattern
5)physical exercise pattern
6)indicator of hypoglycemic fear
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
Type 1 diabetes patients in Juntendo
University Hospital and Aso clinic at the
age of 20 years-old or older when registered
from June, 2019 to October 2019.
Key exclusion criteria
Type 2 diabetes, secondary diabetes and
monogenic diabetes will be excluded.
Target sample size
450
Research contact person
Name of lead principal investigator
| 1st name | Junko |
| Middle name | |
| Last name | Sato |
Organization
Juntendo University Graduate School of
Medicine
Division name
Department of Metabolism and Endocrinology
Zip code
1138421
Address
2-1-1 Hongo, Bunkyoku, Tokyo
TEL
03-3813-3111
jsato@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Junko |
| Middle name | |
| Last name | Sato |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Metabolism and Endocrinology
Zip code
1138421
Address
2-1-1 Hongo, Bunkyoku, Tokyo
TEL
03-3813-3111
Homepage URL
jsato@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Graduate School of
Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Metabolism and Endocrinology,
Juntendo University Graduate School of
Medicine
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
Ethics committee at Juntendo University Hospital
Address
3-1-3 Hongo, Bunkyoku, Tokyo
Tel
03-5802-1589
jun-rinri@juntendo.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
| 2021 | Year | 05 | Month | 01 | 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
477
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
| 2019 | Year | 10 | Month | 17 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 17 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 30 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study of 5 years
Management information
Registered date
| 2021 | Year | 05 | Month | 01 | Day |
Last modified on
| 2021 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050343
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
