UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018692 |
|---|---|
| Receipt number | R000021636 |
| Scientific Title | Evaluation of validity of the advanced glucose monitoring (Flash Glucose Monitoring) |
| Date of disclosure of the study information | 2015/09/01 |
| Last modified on | 2016/10/26 12:36:13 |
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Basic information
Public title
Evaluation of validity of the advanced glucose monitoring (Flash Glucose Monitoring)
Acronym
Evaluation of FGM
Scientific Title
Evaluation of validity of the advanced glucose monitoring (Flash Glucose Monitoring)
Scientific Title:Acronym
Evaluation of FGM
Region
| Japan |
Condition
Condition
Diabetes on insulin treatment
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the validity of advance glucose monitoring (Flash Glucose Monitoring)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
WHO-5 questionnaire
DTSQ
safety evaluation sheet
after 2 weeks intervention by Flash Glucose Monitoring
Key secondary outcomes
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
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Flash Glucose Monitoring
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
diabetes on insulin treatment
Key exclusion criteria
diabetes without insulin treatment
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Rimei Nishimura |
Organization
Jikei University School of Medicine
Division name
Division of Diabetes, Metabolism and Endocrinology Department of Internal Medicine
Zip code
Address
3-25-8 Nishishimbashi, Minato-ku, Tokyo 105-8461 Japan
TEL
03-3433-1111
rimei@jikei.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Rimei Nishimura |
Organization
Jikei University School of Medicine
Division name
Division of Diabetes, Metabolism and Endocrinology Department of Internal Medicine
Zip code
Address
3-25-8 Nishishimbashi, Minato-ku, Tokyo 105-8461 Japan
TEL
03-3433-1111
Homepage URL
rimei@jikei.ac.jp
Sponsor or person
Institute
Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Jikei University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Diabetes, Endocrinology and Nutrition, Kyoto University
Department of Pediatrics, Osaka City University Hospital
Eizyu Memorial Hospital
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
東京慈恵会医科大学附属病院（東京都）
京都大学医学部附属病院（京都府）
大阪市立大学附属病院（大阪府）
永寿記念病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 09 | 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
Completed
Date of protocol fixation
| 2015 | Year | 08 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 10 | 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
| 2015 | Year | 08 | Month | 17 | Day |
Last modified on
| 2016 | Year | 10 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021636
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
