UMIN-CTR Clinical Trial

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.go.jp

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	国立国際医療研究センター(東京都)

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	Open public recruiting
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	2022 Year 08 Month 26 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000047422