UMIN-CTR Clinical Trial

Basic information
Public title	Relationship between compliance of Self-Monitoring of Blood Glucose (SMBG) and control of blood glucose
Acronym	Compliance of SMBG and blood glucose control
Scientific Title	Relationship between compliance of Self-Monitoring of Blood Glucose (SMBG) and control of blood glucose
Scientific Title:Acronym	Compliance of SMBG and blood glucose control
Region	Japan

Condition
Condition	Type 2 diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate if reduction of pain by blood sampling from flat of a hand in Self-Monitoring of Blood Glucose (SMBG) affects compliance of SMBG and control of blood glucose
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1) Level of HbA1c reduction 2) Number of times of SMBG (Compliance)
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	5
Purpose of intervention	Treatment
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	Blood sampling from flat of a hand drugs
Interventions/Control_2	Blood sampling from a finger tip
Interventions/Control_3	No operation of SMBG
Interventions/Control_4	Treatment by only oral anti-diabetic drugs
Interventions/Control_5	Treatment by insulin
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. Type 2 DM 2. No experience of SMBG within 1 year 3. Patients who can do SMBG 4. HbA1c&#8805;5.8%, or FBS&#8805;110mg/dl 5. No improvement by0.5% or more in HbA1c in 3 months 6. 20 years old or more 7. Male or female 8. Patients who can agree with written consent
Key exclusion criteria	1. Type 1 DM or secondary diabetes 2. Patients who performed SMBG in 1 year 3. Improvement by 0.5% or more in HbA1c in 3 months 4. Patients who have depression, psychiatric diseases and alcoholism 5. Patients who have malignant cancers 6. Patients who have abnormal hemoglobin 7. Patients who are not permitted to participate in this trial by attending doctors
Target sample size	400

Research contact person
Name of lead principal investigator	1st name Middle name Last name INAGAKI, nobuya
Organization	Graduate School of Medicine, Kyoto University
Division name	Department of Diabetes and Clinical Nutrition
Zip code
Address	Syogoin Kawahara-cho 54, Sakyo-ku, Kyoto-city, Kyoto, Japan
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name
Organization	Graduate Shcool of Medicine, Kyoto University
Division name	Department of Diabetes and Clinical Nutrition
Zip code
Address
TEL	075-751-3560
Homepage URL
Email

Sponsor
Institute	Dapartment of Diabetes and Clinical Nutrition, Graduate School of Medicine, Kyoto Universiy
Institute
Department

Funding Source
Organization	Johnson and Johnson
Organization
Division
Category of Funding Organization	Profit organization
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	2009 Year 01 Month 01 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	Preinitiation
Date of protocol fixation	2008 Year 11 Month 25 Day
Date of IRB
Anticipated trial start date	2009 Year 01 Month 01 Day
Last follow-up date	2010 Year 11 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2008 Year 11 Month 25 Day
Last modified on	2008 Year 11 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001841

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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