UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Shu Meguro
Organization	Keio University school of medicine
Division name	Nephrology, endocrinology, and metabolism department
Address	35, Shinanomachi, Shinjuku-ku, Tokyo
TEL	03-3353-1211
Email	shumeg@z8.keio.jp

Public contact
Name of contact person	Shu Meguro
Organization	Keio University school of medicine
Division name	Nephrology, endocrinology, and metabolism department
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 03 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000009969