UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008480 |
|---|---|
| Receipt number | R000009969 |
| Scientific Title | A randomised controlled clinical study to evaluate the efficacy and quality of life of structured self glucose monitoring in non-insulin treated type 2 diabetes mellitus patients in Japan |
| Date of disclosure of the study information | 2012/07/20 |
| Last modified on | 2017/01/23 11:49:25 |
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Basic information
Public title
A randomised controlled clinical study to evaluate the efficacy and quality of life of structured self glucose monitoring in non-insulin treated type 2 diabetes mellitus patients in Japan
Acronym
Effect on Quality of life and Efficacy of STructured self glucose monitoring in non-insulin treated type 2 diabetes mellitus patients in Japan (QUEST)
Scientific Title
A randomised controlled clinical study to evaluate the efficacy and quality of life of structured self glucose monitoring in non-insulin treated type 2 diabetes mellitus patients in Japan
Scientific Title:Acronym
Effect on Quality of life and Efficacy of STructured self glucose monitoring in non-insulin treated type 2 diabetes mellitus patients in Japan (QUEST)
Region
| Japan |
Condition
Condition
type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In Japan, there has yet been a published study that evaluates the effect of structured self glucose monitoring on glycemic control and quality of life in non-insulin treated type 2 diabetes mellitus patients despite the availability of data from similar studies conducted on non-Japanese patients.
The purpose of the study is to evaluate the effect of self glucose monitoring in a structured manner on glycemic control (as measured by HbA1c) and on quality of life (as scored on the PAID and DTSQ questionnaire) in Japanese patients with type 2 diabetes mellitus and not treated with insulin.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
HbA1c after 6 months and 12months
Key secondary outcomes
glycoalbumin after 6 months and 12months
change of glycoalbumin/HbA1c ratio after 6 months and 12months
change of BMI ratio after 6 months and 12months
change of QOL after 6 months and 12months
frequency and pattern of severe hypoglycemia
frequency and pattern of fasting/postprandial hyperglycemia
opinions against
Accu-Chek® 360 from study subjects and medical stuffs
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
Nutritional consultation three times in first six months and ST-SMBG for a year
Interventions/Control_2
Nutritional consultation three times in first six months without SMBG
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
Type 2 diabetes
HbA1c within recent 2 months over 7%
Key exclusion criteria
Already treated by insulin
Already performed SMBG
Who cannot perform SMBG by some reason like dementia
Pregnant
Who have such diseases which affect the values of Hba1c as end-stage renal disease, liver cirrhosis, thyroid disease, and hematological disorders
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shu Meguro |
Organization
Keio University school of medicine
Division name
Nephrology, endocrinology, and metabolism department
Zip code
Address
35, Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
shumeg@z8.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shu Meguro |
Organization
Keio University school of medicine
Division name
Nephrology, endocrinology, and metabolism department
Zip code
Address
35, Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
Homepage URL
shumeg@z8.keio.jp
Sponsor or person
Institute
Keio University school of medicine, Nephrology, endocrinology, and metabolism department
Institute
Department
Personal name
Funding Source
Organization
none
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
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
| 2012 | Year | 07 | Month | 20 | 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
Completed
Date of protocol fixation
| 2012 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 07 | Month | 20 | Day |
Last modified on
| 2017 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009969
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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