UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The efficacy of structured self-monitoring of blood glucose (SMBG)on glycemic control in non-insulin treated type 2 diabetes
Title of the study (Brief title)	Structured SMBG Study
Region	Japan

Condition
Condition	type 2 diabetes
Classification by specialty	Medicine in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of structured SMBG on glycemic control in non-insulin treated type 2 diabetes
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change in HbA1c in 6 months
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	structured SMBG
Interventions/Control_2	Routine 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	1. diet, exercise, and/or OHA-treated type 2 diabetes 2. Age >= 20 3. male and female 4. diabetes duration >= 6 months 5. 6.5% <= HbA1c < 8.5% 6. No improvement of HbA1c > 0.5% in 2 months 7. No SMBG performance in 3 months 8. Informed consent
Key exclusion criteria	1. insulin or GLP-1 receptor agonists-treated patients 2. pregnancy 3. alcoholism, depression, mental diseases 4. Abnormal Hemoglobin 5. Severe complications and comorbidities 6. Malignancy 7. Treatment changes in 2 months
Target sample size	60

Research contact person
Name of lead principal investigator	Nobuya Inagaki
Organization	Kyoto University
Division name	Department of Diabetes and Clinical Nutrition
Address	54 Syogoin Kawaramachi Sakyo-ku Kyoto
TEL	075-751-3560
Email	harasima@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Shinichi Harashima
Organization	Kyoto University
Division name	Department of Diabetes and Clinical Nutrition
Address	54 Syogoin Kawaramachi Sakyo-ku Kyoto
TEL	075-751-3560
Homepage URL
Email	harasima@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Kyoto University
Institute
Department

Funding Source
Organization	Kyoto University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

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 11 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 09 Month 23 Day
Anticipated trial start date	2012 Year 11 Month 01 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	Published
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 09 Month 23 Day
Last modified on	2017 Year 06 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010514