UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018692
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email rimei@jikei.ac.jp

Sponsor
Institute Jikei University School of Medicine
Institute
Department

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
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 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
URL(English) https://upload.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
Registered date File name


Contact us.