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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000019727
Receipt No. R000022719
Scientific Title The relation of between glucose variability and HbA1c, GA and 1,5AG in diabetes patients with insulin therapy using Continuous Glucose Monitoring system (iPro2) cross sectional study
Date of disclosure of the study information 2015/11/10
Last modified on 2016/08/29

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Basic information
Public title The relation of between glucose variability and HbA1c, GA and 1,5AG in diabetes patients with insulin therapy using Continuous Glucose Monitoring system (iPro2)
cross sectional study
Acronym Glucose variability in diabetes patients with insulin therapy using Continuous Glucose Monitoring system (iPro2)
Scientific Title The relation of between glucose variability and HbA1c, GA and 1,5AG in diabetes patients with insulin therapy using Continuous Glucose Monitoring system (iPro2)
cross sectional study
Scientific Title:Acronym Glucose variability in diabetes patients with insulin therapy using Continuous Glucose Monitoring system (iPro2)
Region
Japan

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

Objectives
Narrative objectives1 To determine the relation of between glucose variability and HbA1c, GA and 1,5AG in diabetes patients with insulin therapy using Continuous Glucose Monitoring system (iPro2)
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Relationship between standard deviation and GA, 1.5AG
Key secondary outcomes (1) The correlation between SD and HbA1c
(2) The correlation between GA, 1,5AG and the variables listed below.
Mean mean amplitude of glycemic excursions (MAGE), percentage of time >180 mg/dl, >140 mg/dl, mean of daily difference of blood glucose(MODD)

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 (1)Subjects who treatment with insulin for treatment of diabetes outpatients
(2)Subjects who give consent document about participation in the clinical study
Key exclusion criteria (1) With erythropoietin for renal anemia
(2)With anemia (Hb<10 g/dl)
(3) With CKD and cirrhosis
(4) With abnormal hemoglobinemia
(5) With nephrotic syndrome
(6)With steroid
(7)With acarbose
(8) hospitalized patients and discharge within two months
(9) Considered as inadequate by the investigator
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yosuke Okada
Organization University of Occupational and Environmental Health
Division name First Department of Internal Medicine, School of Medicine
Zip code
Address 1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu-shi 807-8555, Japan
TEL +8100936031611
Email y-okada@med.uoeh-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroko Mori
Organization University of Occupational and Environmental Health
Division name First Department of Internal Medicine, School of Medicine
Zip code
Address 1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu-shi 807-8555, Japan
TEL +8100936031611
Homepage URL
Email morihiro@med.uoeh-u.ac.jp

Sponsor
Institute University of Occupational and Environmental Health
Institute
Department

Funding Source
Organization University of Occupational and Environmental Health
Organization
Division
Category of Funding Organization Other
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
2015 Year 11 Month 10 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 No longer recruiting
Date of protocol fixation
2012 Year 07 Month 13 Day
Date of IRB
Anticipated trial start date
2012 Year 07 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information cross sectional study

Management information
Registered date
2015 Year 11 Month 10 Day
Last modified on
2016 Year 08 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022719

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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