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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000001525
Receipt No. R000001841
Scientific Title Relationship between compliance of Self-Monitoring of Blood Glucose (SMBG) and control of blood glucose
Date of disclosure of the study information 2009/01/01
Last modified on 2008/11/25

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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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