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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030417
Receipt No. R000034730
Scientific Title A comparison between flash and continuous glucose monitoring systems in type 2 diabetes
Date of disclosure of the study information 2017/12/15
Last modified on 2017/12/15

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Basic information
Public title A comparison between flash and continuous glucose monitoring systems in type 2 diabetes
Acronym A comparison between FGM and CGM in type 2 diabetes
Scientific Title A comparison between flash and continuous glucose monitoring systems in type 2 diabetes
Scientific Title:Acronym A comparison between FGM and CGM in type 2 diabetes
Region
Japan

Condition
Condition Type 2 diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the accuracy between FGM and CGM in type 2 diabetes
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes To evaluate the performance of FGM against CGM during 7-day period
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 iPro2 and Libre Pro
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

Not applicable
Gender Male and Female
Key inclusion criteria the inpatients with type 2 diabetes
Key exclusion criteria the subjects during pregnancy or lactation
the subjects judged to be ineligible by attending physicians for this research
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sayaka Ida
Organization Mie chuo medical center
Division name Depertment of internal medicine
Zip code
Address 2158-5,Hisai myojin-chou,Tsu-shi,Mie
TEL 059-259-1211
Email n906eb@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Sayaka Ida
Organization Mie chuo medical center
Division name Depertment of internal medicine
Zip code
Address 2158-5,Hisai myojin-chou,Tsu-shi,Mie
TEL 059-259-1211
Homepage URL
Email n906eb@gmail.com

Sponsor
Institute Mie chuo medical center
Institute
Department

Funding Source
Organization Department of Internal medicine,Mie chuo medical center
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 12 Month 15 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
2017 Year 06 Month 07 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 07 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 12 Month 15 Day
Last modified on
2017 Year 12 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034730

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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