UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003004 |
|---|---|
| Receipt number | R000003639 |
| Scientific Title | Investigation of the effects on diabetes control using SMBG device eqipped with color diaplay |
| Date of disclosure of the study information | 2010/01/09 |
| Last modified on | 2015/01/09 10:59:40 |
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Basic information
Public title
Investigation of the effects on diabetes control using SMBG device eqipped with color diaplay
Acronym
Investigation of the effects on diabetes control using SMBG device wquipped with color diaplay
Scientific Title
Investigation of the effects on diabetes control using SMBG device eqipped with color diaplay
Scientific Title:Acronym
Investigation of the effects on diabetes control using SMBG device wquipped with color diaplay
Region
| Japan |
Condition
Condition
Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to clarify the efficacy of the diabetes control using the SMBG device equipped with color display
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Change in HbA1c
Key secondary outcomes
Frequency of hyperglycemia/ hypoglycemia
The"M value": the magnitude of glucose swing
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Using SMBG device with color display
Interventions/Control_2
Using SMBG device without color display
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients planed to attendig outpatint branch of Kobe University Hospital regularly after discharge
Key exclusion criteria
The patients who might not alive for more than 6 month after discharge
The patients who can't use the SMBG device by themselves
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Sakaguchi |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Diabetes,Metabolism and Endocrinology, Department of Internal Medicine
Zip code
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Sakaguchi |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Diabetes,Metabolism and Endocrinology, Department of Internal Medicine
Zip code
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017
TEL
Homepage URL
Sponsor or person
Institute
Kobe University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
| 2010 | Year | 01 | Month | 09 | 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
| 2010 | Year | 01 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 02 | Month | 01 | 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
| 2010 | Year | 01 | Month | 09 | 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=R000003639
