UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002569 |
|---|---|
| Receipt number | R000003136 |
| Scientific Title | A study of blood glucose fluctuation examined by continous glucose monitoring system |
| Date of disclosure of the study information | 2009/11/01 |
| Last modified on | 2017/04/07 10:49:25 |
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Basic information
Public title
A study of blood glucose fluctuation examined by continous glucose monitoring system
Acronym
A study of blood glucose fluctuation examined by continous glucose monitoring system
Scientific Title
A study of blood glucose fluctuation examined by continous glucose monitoring system
Scientific Title:Acronym
A study of blood glucose fluctuation examined by continous glucose monitoring system
Region
| Japan |
Condition
Condition
Diabetes Mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify blood glucose fluctuation or variablility in diabetes patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
relationship between 1,5 AG and parameters obtained with CGM
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
Anyone who is suitable for monitoring continuious blood glucose level
Key exclusion criteria
Anyone who has skin trouble
Target sample size
100
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
Zip code
Address
7-5-1 Kusunoki-cho, chuo-ku, Kobe
TEL
078-382-6596
kzhkskgc@med.kobe-u.ac.jp
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
Zip code
Address
7-5-1, Kusunoki-Cho, Chuoku
TEL
078-382-6596
Homepage URL
kzhkskgc@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Graduate School of Medicine, Division of Diabetes, Metabolism and Endocrinology
Institute
Department
Personal name
Funding Source
Organization
Kobe University Graduate School of Medicine, Division of Diabetes, Metabolism and Endocrinology
Organization
Division
Category of Funding Organization
Self funding
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
神戸大学医学部付属病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 11 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2009 | Year | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cpmpare parameter obtained with CGM and 1,5AG
Management information
Registered date
| 2009 | Year | 10 | Month | 01 | Day |
Last modified on
| 2017 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003136
