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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012417
Receipt No. R000014508
Scientific Title The construction and evaluation of internet-based Diabetes Education and Managementin type 2 diabetes patients
Date of disclosure of the study information 2013/12/01
Last modified on 2015/01/09

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Basic information
Public title The construction and evaluation of internet-based Diabetes Education and Managementin type 2 diabetes patients
Acronym iDEM trial
Scientific Title The construction and evaluation of internet-based Diabetes Education and Managementin type 2 diabetes patients
Scientific Title:Acronym iDEM trial
Region
Japan

Condition
Condition type 2 diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Type 2 diabetes patients who are working sometimes discontinue their consultation because of their pressing work, which may be one of the reason for future events of ischemic heart disease, celebral infarction, ganrene, hemodialysis or blindness. To improve such situation, we constructed the new system of internet-based diabetes education and management in type 2 diabetes patients who are working and evaluate the efficacy of it.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the average of HbA1c, the standard deviation of HbA1c, the rate of variability of HbA1c, the average of body weight, the standard deviation of body weight,the rate of variability of body weight
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 internet-based diabetes education and management
Interventions/Control_2 common consultation
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
80 years-old >=
Gender Male and Female
Key inclusion criteria type 2 diabetes outpatients who consent participating this study
Key exclusion criteria patients who receive insulin therapy
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kumiko Hamano
Organization Kantoh Rosai Hospital
Division name department of diabetes and endocrinology
Zip code
Address 1-1 Kizukisumiyosicho Nakakhara-Ku, Kawasaki-city, Kanagawa prefecture
TEL 044-411-3131
Email teamdm@kantoh.rofuku.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kumiko Hamano
Organization Kantoh Rosai Hospital
Division name department of diabetes and endocrinology
Zip code
Address 1-1 Kizukisumiyosicho Nakakhara-Ku, Kawasaki-city, Kanagawa prefecture
TEL 044-411-3131
Homepage URL
Email teamdm@kantoh.rofuku.go.jp

Sponsor
Institute Kantoh Rosai Hospital
Institute
Department

Funding Source
Organization Kantoh Rosai Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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
2013 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

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
2013 Year 07 Month 10 Day
Date of IRB
Anticipated trial start date
2013 Year 07 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 11 Month 27 Day
Last modified on
2015 Year 01 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014508

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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