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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041535
Receipt No. R000047422
Scientific Title Retrospective observational study in Japanese type 1 diabetes patients using a medical record database
Date of disclosure of the study information 2020/09/01
Last modified on 2020/08/25

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Basic information
Public title Clinical survey on Japanese type 1 diabetes patients
Acronym Clinical survey on Japanese type 1 diabetes patients
Scientific Title Retrospective observational study in Japanese type 1 diabetes patients using a medical record database
Scientific Title:Acronym Epidemiologic study in 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 an retrospective observational database study in Japanese type 1 diabetes using the J-DREAMS(Japan Diabetes compREhensive database project based on an Advanced electronic Medical record System) database. Epidemiologic survey will be performed to understand the present clinical practice and to achieve appropriate treatment regimen.
Basic objectives2 Others
Basic objectives -Others Epidemiologic study
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes This is a descriptive database research in type 1 diabetes patients.
Key secondary outcomes Stratified analysis will also be performed based on each subtype of type 1 diabetes (Fulminant type 1 diabetes, Acute onset type 1 diabetes and Slowly progressive type 1 diabetes).


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 at the age of 20 years-old or older when registered in J-DREAMS database
Key exclusion criteria Type 2 diabetes, secondary diabetes and monogenic diabetes will be excluded
Target sample size 4000

Research contact person
Name of lead principal investigator
1st name Mitsuru
Middle name
Last name Oosugi
Organization National Center of Global Health and Medicine
Division name Diabetes and Metabolism Information Center
Zip code 162-8655
Address 1-21-1 Toyama Shinjyuku-ku
TEL 03-3202-7181
Email moosugi@hosp.ncgm.go.jp

Public contact
Name of contact person
1st name Noriko
Middle name
Last name Kodani
Organization National Center of Global Health and Medicine
Division name Diabetes, Endocrinology and Metabolism
Zip code 162-8655
Address 1-21-1 Toyama Shinjyuku-ku
TEL 03-3202-7181
Homepage URL http://jdreams.jp/
Email nkodani@hosp.ncgm.gojp

Sponsor
Institute National Center of Global Health and Medicine
Institute
Department

Funding Source
Organization National Center of Global Health and Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization National Center of Global Health and Medicine
Address 1-21-1 Toyama Shinjyuku-ku
Tel 03-3202-7181
Email kenkyu-shinsa@hosp.ncgm.go.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 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
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 Preinitiation
Date of protocol fixation
2020 Year 07 Month 20 Day
Date of IRB
2020 Year 09 Month 01 Day
Anticipated trial start date
2020 Year 09 Month 01 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2025 Year 03 Month 31 Day

Other
Other related information Retrospective Observational study

Criteria
All type 1 diabetes outpatients and inpatients who were registered in the database

Data
Background data. Prescription. Laboratory data. Complications.

http://jdreams.jp/

Management information
Registered date
2020 Year 08 Month 24 Day
Last modified on
2020 Year 08 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047422

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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