UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002986 |
|---|---|
| Receipt number | R000003622 |
| Scientific Title | Effect of continuous glucose monitering on glycemic control in diabetes mellitus |
| Date of disclosure of the study information | 2010/03/01 |
| Last modified on | 2010/01/06 15:16:29 |
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Basic information
Public title
Effect of continuous glucose monitering on glycemic control in diabetes mellitus
Acronym
Effect of CGM on glycemic control
Scientific Title
Effect of continuous glucose monitering on glycemic control in diabetes mellitus
Scientific Title:Acronym
Effect of CGM on glycemic control
Region
| Japan |
Condition
Condition
Diabetes mellitaus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to clarify the effect of CGM on glycemic control in patients with diabetes mellitus
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1)the average of blood glucose
2)variability of blood glucose
Key secondary outcomes
the change of blood glucose, comliance, others
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Measurement of24h blood glucose by using CGMS Gold and adjust doses of OHA or insulin. Then, HbA1c and blood glucose are checked at 0, 1, 3, and 6 months.
Interventions/Control_2
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
Men and women over 20 years old who fulfill the following criteria:1)disease of any type of Diabetes mellitus,
2) The level of HbA1c is more than 6.5%.
Key exclusion criteria
1)Risk of bleeding
2) An idividual who is judged as inappropriate for this study by a medical doctor
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | tadashi yamakawa |
Organization
Yokohama City University Medical Center
Division name
Department of Diabetes
Zip code
Address
4-57 Urafune-cho,minami-ku,yokohama,232-0024,Japan
TEL
045-261-5656
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | tadashi yamakawa |
Organization
Yokohama City University Medical Center
Division name
Department of Diabetes
Zip code
Address
4-57 Urafune-cho,minami-ku,yokohama,232-0024,Japan
TEL
045-261-5656
Homepage URL
Sponsor or person
Institute
Yokohama City University Medical Center
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University Medical Center
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
横浜市立大学医学部附属市民総合医療センター
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 03 | 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
| 2010 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 01 | Month | 06 | Day |
Last modified on
| 2010 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003622
