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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000481
Receipt No. R000000582
Scientific Title Japan Diabetes Outcome Intervention Trial 2 (J-DOIT2) Pilot research about efficiency of a system supporting type 2 diabetes mellitus medical care by a family doctor
Date of disclosure of the study information 2006/09/01
Last modified on 2008/03/02

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Basic information
Public title Japan Diabetes Outcome Intervention Trial 2 (J-DOIT2)
Pilot research about efficiency of a system supporting type 2 diabetes mellitus medical care by a family doctor
Acronym Japan Diabetes Outcome Intervention Trial 2 (J-DOIT2)
Scientific Title Japan Diabetes Outcome Intervention Trial 2 (J-DOIT2)
Pilot research about efficiency of a system supporting type 2 diabetes mellitus medical care by a family doctor
Scientific Title:Acronym Japan Diabetes Outcome Intervention Trial 2 (J-DOIT2)
Region
Japan

Condition
Condition Type 2 Diabetes Mellitus
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We carry out "diabetes mellitus medical care support" for a family doctor and inspect effect improving interruption rate of the type 2 diabetes mellitus patient visiting a clinic for treatment.
Basic objectives2 Others
Basic objectives -Others Estimation of the parameter which is necessary for sample size account toward "large-scale research" and estimate of workability of "large-scale research."
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Estimation of the parameter which is necessary for sample size account toward "large-scale research" and estimate of workability of "large-scale research."
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 The medical care support that a medical care support service center carries out and support by a IT system
Interventions/Control_2 Usual medical care
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
65 years-old >=
Gender Male and Female
Key inclusion criteria 1) The patient who was diagnosed as type 2 diabetes mellitus in another hospital
2) The patient who satisfies criteria of Japan diabetes society
3) The patient who undergoes treatment by diabetes remedy (oral hypoglycemic agent, insulin)
Key exclusion criteria 1) A dialysis patient
2) A inpatient
3) The bedridden patient or the approximately bedridden patient
4) The patient resident in a nursing home
5) The patient with medical history of Blindness or leg amputation
6) The patient who was diagnosed as malignant recently in five years
7) The pregnant patient or the patient with pregnant possibility
8) The patient who undergoes treatment diabetic in plural medical institutions (besides treatment of complication)
9) The patient that type 1 diabetes mellitus is doubted
Target sample size 2400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masashi Kobayashi
Organization Toyama University Hospital
Division name The director of a hospital
Zip code
Address 2630 Sugitani, Toyama 930-0194 Japan
TEL 076-434-7700
Email

Public contact
Name of contact person
1st name
Middle name
Last name katsuya Yamazaki
Organization University of Toyama
Division name Faculty of Medicine, Internal Medicine 1
Zip code
Address 2630 Sugitani, Toyama 930-0194 Japan
TEL 076-434-7287
Homepage URL http://www.pimrc.or.jp/diabetes/
Email kyamazak@med.u-toyama.ac.jp

Sponsor
Institute Japan Foundation for the Promotion of International Medical Research Cooperation
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2006 Year 09 Month 01 Day

Related information
URL releasing protocol http://www.pimrc.or.jp/diabetes/research2_protocol.pdf
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 Completed
Date of protocol fixation
2006 Year 08 Month 11 Day
Date of IRB
Anticipated trial start date
2006 Year 09 Month 01 Day
Last follow-up date
2008 Year 01 Month 01 Day
Date of closure to data entry
2008 Year 02 Month 01 Day
Date trial data considered complete
2008 Year 03 Month 01 Day
Date analysis concluded
2008 Year 04 Month 01 Day

Other
Other related information

Management information
Registered date
2006 Year 09 Month 01 Day
Last modified on
2008 Year 03 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000582

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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