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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008480
Receipt No. 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

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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
Email 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
Email shumeg@z8.keio.jp

Sponsor
Institute Keio University school of medicine, Nephrology, endocrinology, and metabolism department
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009969

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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