UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012417 |
|---|---|
| Receipt number | 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 18:20:46 |
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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
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
teamdm@kantoh.rofuku.go.jp
Sponsor or person
Institute
Kantoh Rosai Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014508
