UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021714 |
|---|---|
| Receipt number | R000025013 |
| Scientific Title | Japan Diabetes compREhensive database project based on an Advanced electronic Medical record System |
| Date of disclosure of the study information | 2016/04/01 |
| Last modified on | 2021/10/05 09:28:30 |
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Basic information
Public title
Japan Diabetes compREhensive database project based on an Advanced electronic Medical record System
Acronym
Japan Diabetes compREhensive database project based on an Advanced electronic Medical record System(J-DREAMS)
Scientific Title
Japan Diabetes compREhensive database project based on an Advanced electronic Medical record System
Scientific Title:Acronym
Japan Diabetes compREhensive database project based on an Advanced electronic Medical record System(J-DREAMS)
Region
| Japan |
Condition
Condition
Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To collect clinical data of hospitals with Standardized Electronic chart of diabetes and to think over how to apply these database to new clinical trials.
Basic objectives2
Others
Basic objectives -Others
Database
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of patients
Key secondary outcomes
glycemic control, diabetes complications, death
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Diabetes outpatients and inpatients who were seen by a doctor in a department of medical facilities participating in the study
Key exclusion criteria
none
Target sample size
30000
Research contact person
Name of lead principal investigator
| 1st name | Mitsuru |
| Middle name | |
| Last name | Ohsugi |
Organization
National Center Hospital for Global Health and Medicine
Division name
Diabetes and Metabolism Information Center
Zip code
162-8655
Address
1-21-1 Toyama,Shinju-ku,Tokyo-to
TEL
03-3202-7181
j-dreams@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | Mitsuru |
| Middle name | |
| Last name | Ohsugi |
Organization
National Center for Global Health and Medicine
Division name
J-DREAMS Office, Diabetes and Metabolism Information Center
Zip code
162-8655
Address
1-21-1 Toyama,Shinju-ku,Tokyo-to
TEL
03-5273-6894
Homepage URL
http://jdreams.jp/
j-dreams@hosp.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
National Center of Global Health and Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center for Global Health and Medicine
Address
1-21-1 Toyama,Shinju-ku,Tokyo
Tel
03-3202-7181
mailto:rinrijm@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
| 2016 | Year | 04 | 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
| 2015 | Year | 12 | Month | 21 | Day |
Date of IRB
| 2014 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cohort study
Criteria
All Diabetes outpatients and inpatients who were seen by a doctor in a department of medical facilities participating in the study
Data
Background data. Prescription. Laboratory data. Complications. Date of Describing.
http://jdreams.jp/
Management information
Registered date
| 2016 | Year | 03 | Month | 31 | Day |
Last modified on
| 2021 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025013
