UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009192 |
|---|---|
| Receipt number | R000010793 |
| Scientific Title | Study for the Efficacy Assessment of the Standard Diabetes Manual |
| Date of disclosure of the study information | 2012/10/26 |
| Last modified on | 2018/01/26 13:52:44 |
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Basic information
Public title
Study for the Efficacy Assessment of the Standard Diabetes Manual
Acronym
SEAS-DM
Scientific Title
Study for the Efficacy Assessment of the Standard Diabetes Manual
Scientific Title:Acronym
SEAS-DM
Region
| Japan |
Condition
Condition
diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy of the Standard Diabetes Manual issued by National Center for Global Health and Medicine
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Proportion of the following test performance:
1. Evaluation of retinopathy by an ophthalmologist (once a year)
2. Measurement of urinary albumin excretion (every 6 months)
3. Measurement of serum creatinine level (every 6 months)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
1 The participating clinical practitioners will be randomized to either "Manual group" or "Guide group".
2 "Diabetes Treatment Guide 2012-2013", published by the Japan Diabetes Society will be provided to the "control group".
Interventions/Control_2
Both "Diabetes Treatment Guide 2012-2013" and "the Standard Diabetes Manual" published by National Center for Global Health and Meidicine be provided to the "Manual group"
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Those who satisfies all the following conditions:
1 Type 2 diabetes mellitus
2 Age between 20 and 75 years
3 Under care by the primary physician for more than 1 year
Key exclusion criteria
None
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuhiko Noda |
Organization
National Center for Global Health and Medicine
Division name
Diabetes and Metabolic Diseases
Zip code
Address
1-21-1 Toyama, Shinjuku, Tokyo, Japan
TEL
03-3202-7181
noda-3im@io.ocn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsuhiko Noda |
Organization
National Center for Global Health and Medicine
Division name
Diabetes and Metabolic Diseases
Zip code
Address
1-21-1 Toyama, Shinjuku, Tokyo, Japan
TEL
03-3202-7181
Homepage URL
noda-3im@io.ocn.ne.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
Health Sciences Research Grant from the Ministry of Health, Labour and Welfare of Japan
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
1 Yamaguchi University, Japan
2 Aizawa Hospital, Japan
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
| 2012 | Year | 10 | Month | 26 | 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
Completed
Date of protocol fixation
| 2012 | Year | 10 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 27 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 12 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 10 | Month | 26 | Day |
Last modified on
| 2018 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010793
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
