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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028412
Receipt No. R000032517
Scientific Title Study about the discrepancies between monitoring data of FreeStyle libre and SMBG.
Date of disclosure of the study information 2017/07/27
Last modified on 2018/07/28

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Basic information
Public title Study about the discrepancies between
monitoring data of FreeStyle libre and SMBG.
Acronym Study about the discrepancies between
monitoring data of FreeStyle libre and SMBG.
Scientific Title Study about the discrepancies between
monitoring data of FreeStyle libre and SMBG.
Scientific Title:Acronym Study about the discrepancies between
monitoring data of FreeStyle libre and SMBG.
Region
Japan

Condition
Condition healthy subjects
patients with diabetes, using insulin
Classification by specialty
Medicine in general Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Investigate the discrepancies of monitoring
data between FreeStyle libre and SMBG, to use
the device properly.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The level of discrepancies of monitoring
data between FreeStyle libre and SMBG.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 To evaluate the discrepancies among the
glucose data of libre, SMBG and venous blood
sample(at OGTT only for healthy subjects).
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
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria 1.Agreemnt with paper.
2.Healthy subjects.
Patients with diabetes using insulin.
Key exclusion criteria 1.Subjects with renal dysfunction
(>=Cr1.5mg/dl)and liver dysfunction
(ex.cirrhosis).
2.Inappropriate for the research.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Junko Sato
Organization Juntendo University Shizuoka Hospital
Division name Department of Diabetes, Endocrinology and Metabolism
Zip code
Address 1129 Nagaoka, Izunokunishi, Shizuoka, Japan
TEL 055-948-3111
Email jsato@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Junko Sato
Organization Juntendo University Shizuoka Hospital
Division name Department of Diabetes, Endocrinology and Metabolism
Zip code
Address 1129 Nagaoka, Izunokunishi, Shizuoka, Japan
TEL 055-948-3111
Homepage URL
Email jsato@juntendo.ac.jp

Sponsor
Institute Juntendo University Shizuoka Hospital
Institute
Department

Funding Source
Organization Juntendo University Shizuoka Hospital
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

Other administrative information
Date of disclosure of the study information
2017 Year 07 Month 27 Day

Related information
URL releasing protocol
Publication of results Partially 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
2017 Year 03 Month 13 Day
Date of IRB
Anticipated trial start date
2017 Year 07 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
2017 Year 07 Month 27 Day
Last modified on
2018 Year 07 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032517

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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