UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000000481
Receipt number 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 18:31:09

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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 or person

Institute

Japan Foundation for the Promotion of International Medical Research Cooperation

Institute

Department

Personal name



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

Value
https://center6.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