UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019727 |
|---|---|
| Receipt number | 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 08:24:58 |
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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
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
morihiro@med.uoeh-u.ac.jp
Sponsor or person
Institute
University of Occupational and Environmental Health
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022719
