UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030417 |
|---|---|
| Receipt number | R000034730 |
| Scientific Title | A comparison between flash and continuous glucose monitoring systems in type 2 diabetes |
| Date of disclosure of the study information | 2017/12/15 |
| Last modified on | 2021/06/23 18:41:22 |
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Basic information
Public title
A comparison between flash and continuous glucose monitoring systems in type 2 diabetes
Acronym
A comparison between FGM and CGM in type 2 diabetes
Scientific Title
A comparison between flash and continuous glucose monitoring systems in type 2 diabetes
Scientific Title:Acronym
A comparison between FGM and CGM in type 2 diabetes
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the accuracy between FGM and CGM in type 2 diabetes
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
To evaluate the performance of FGM against CGM during 7-day period
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
iPro2 and Libre Pro
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
the inpatients with type 2 diabetes
Key exclusion criteria
the subjects during pregnancy or lactation
the subjects judged to be ineligible by attending physicians for this research
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sayaka Ida |
Organization
Mie chuo medical center
Division name
Depertment of internal medicine
Zip code
Address
2158-5,Hisai myojin-chou,Tsu-shi,Mie
TEL
059-259-1211
n906eb@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sayaka Ida |
Organization
Mie chuo medical center
Division name
Depertment of internal medicine
Zip code
Address
2158-5,Hisai myojin-chou,Tsu-shi,Mie
TEL
059-259-1211
Homepage URL
n906eb@gmail.com
Sponsor or person
Institute
Mie chuo medical center
Institute
Department
Personal name
Funding Source
Organization
Department of Internal medicine,Mie chuo medical center
Organization
Division
Category of Funding Organization
Self funding
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
| 2017 | Year | 12 | Month | 15 | 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
| 2017 | Year | 06 | Month | 07 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 07 | Day |
Last follow-up date
| 2018 | Year | 12 | 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
| 2017 | Year | 12 | Month | 15 | Day |
Last modified on
| 2021 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034730
