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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000044088
Receipt No. 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

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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
Email 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
Email jsato@juntendo.ac.jp

Sponsor
Institute Juntendo University Graduate School of
Medicine
Institute
Department

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
Email 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
URL(English) https://upload.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


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