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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032979
Receipt No. R000037602
Official scientific title of the study Comparison of CGM data between iPro2 and Libre Pro in diabetes mellitus patients undergoing hemodialysis
Date of disclosure of the study information 2018/06/13
Last modified on 2018/06/13

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Basic information
Official scientific title of the study Comparison of CGM data between iPro2 and Libre Pro in diabetes mellitus patients undergoing hemodialysis
Title of the study (Brief title) Comparison of CGM data between iPro2 and Libre Pro
Region
Japan

Condition
Condition Diabetes mellitus patients on hemodialysis
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compaere the CGM data obtained by iPro2 and Libre Pro.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Mean, maximum, minimum, and SD of glucose levels.

The correlation between HbA1c or GA and mean glucose levels obtained by CGM
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 CGM by 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
85 years-old >
Gender Male and Female
Key inclusion criteria Diabetes mellitus patients undergoing hemodialysis whose diabetes treatment regimens has not been changed within three months
Key exclusion criteria type 1 diabetes, chronic liver disease, thyroid dysfunction, gastrointestinal bleeding
Target sample size 10

Research contact person
Name of lead principal investigator Takahiro Yajima
Organization Matsunami General Hospital
Division name Depertment of Nephrology
Address 185-1, dendai, Kasamatsu-chou, Hashima-gun, Gifu
TEL 058-388-0111
Email yajima5639@gmail.com

Public contact
Name of contact person Takahiro Yajima
Organization Matsunami general hospital
Division name Department of Nephrology
Address 185-1, dendai, Kasamatsu-chou, Hashima-gun, Gifu
TEL 058-388-0111
Homepage URL
Email yajima5639@gmail.com

Sponsor
Institute Matsunami general hospital
Institute
Department

Funding Source
Organization Matsunami general hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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
2018 Year 06 Month 13 Day

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2018 Year 06 Month 13 Day
Anticipated trial start date
2018 Year 06 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 06 Month 13 Day
Last modified on
2018 Year 06 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037602

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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