UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041535 |
|---|---|
| Receipt number | 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 | 2022/08/26 12:14:25 |
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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
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/
nkodani@hosp.ncgm.go.jp
Sponsor or person
Institute
National Center of Global Health and Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047422
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
