UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001525 |
|---|---|
| Receipt number | 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 20:27:30 |
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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≥5.8%, or FBS≥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
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
Sponsor or person
Institute
Dapartment of Diabetes and Clinical Nutrition, Graduate School of Medicine, Kyoto Universiy
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001841
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
