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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000002569
Receipt No. 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

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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
Email 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
Email kzhkskgc@med.kobe-u.ac.jp

Sponsor
Institute Kobe University Graduate School of Medicine, Division of Diabetes, Metabolism and Endocrinology
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003136

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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