UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008455 |
|---|---|
| Receipt number | R000009942 |
| Scientific Title | Efficacy of the electronic management system of self monitoring blood glucose in patients with type 1 and type 2 diabetes. |
| Date of disclosure of the study information | 2012/07/17 |
| Last modified on | 2012/07/17 13:53:42 |
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Basic information
Public title
Efficacy of the electronic management system of self monitoring blood glucose in patients with type 1 and type 2 diabetes.
Acronym
Efficacy of e-SMBG in diabetes.
Scientific Title
Efficacy of the electronic management system of self monitoring blood glucose in patients with type 1 and type 2 diabetes.
Scientific Title:Acronym
Efficacy of e-SMBG in diabetes.
Region
| Japan |
Condition
Condition
type 1 and type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy of the electronic management sysytem of self monitoring blood glucose in patients with type 1 diabetes treated with multiple insulin injection and type 2 diabetes treated with diet or oral antidiabetic drugs.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
the changes of glycated hemoglobin and body weight
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
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 |
Interventions/Control_1
Type 2 diabetic patients treated with diet or antidiabetics were divided into contorol and e-SMBG groups. Electronic self monitoring sysytem of blood glucose was applied for first 12 weeks (first period) in eSMBG group, and it was applied all patients for 12 weeks in second period.
Interventions/Control_2
Electronic self monitoring sysytem of blood glucose was applied for 12 weeks in type 1 diabetic patients treated with multiple insulininjection.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Type 2 diabetic patients treated with diet or antidiabetics were divided into contorol and e-SMBG
2. Type 1 diabetic patients treated with multiple insulininjection
Key exclusion criteria
1.The patient who was dicided as an inappopritae subject for this study by the physician.
2. Type 2 diabetic patient who has been applied self monitoring blood glucose (SMBG) in recent three months.
2. Type 2 diabetic patient who has been treated with insulin or GLP-1
analogue in recent three months.
4. Type 1 diabetic patients who were treated with insulin without SMBG.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Munehide Matsuhsia |
Organization
The University of Tokushima
Division name
Diabetes Therapeutics and Research Center
Zip code
Address
3-18-15, Kuramoto-cho, Tokushima, 770-8503, Japan
TEL
088-633-7587
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
The University of Tokushima
Division name
Diabetes Therapeutics and Research Center
Zip code
Address
3-18-15, Kuramoto-cho, Tokushima, 770-8503, Japan
TEL
088-633-7587
Homepage URL
matuhisa@tokushima-u.ac.jp
Sponsor or person
Institute
The University of Tokushima,
Diabetes Therapeutics and Research Center
Institute
Department
Personal name
Funding Source
Organization
Terumo Corporation
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
| 2012 | Year | 07 | Month | 17 | 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
| 2012 | Year | 07 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 07 | Month | 17 | Day |
Last modified on
| 2012 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009942
