UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Yosuke Okada
Organization	University of Occupational and Environmental Health
Division name	First Department of Internal Medicine, School of Medicine
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	Hiroko Mori
Organization	University of Occupational and Environmental Health
Division name	First Department of Internal Medicine, School of Medicine
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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2012 Year 07 Month 13 Day
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

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Publication of results	Unpublished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