UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030792 |
|---|---|
| Receipt number | R000035160 |
| Scientific Title | Investigation of new index to evaluate accuracy of continuous glucose monitoring |
| Date of disclosure of the study information | 2018/01/13 |
| Last modified on | 2018/05/09 11:52:27 |
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Basic information
Public title
Investigation of new index to evaluate accuracy of continuous glucose monitoring
Acronym
new index to evaluate accuracy of continuous glucose monitoring
Scientific Title
Investigation of new index to evaluate accuracy of continuous glucose monitoring
Scientific Title:Acronym
new index to evaluate accuracy of continuous glucose monitoring
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the formula which can evaluate the accuracy of CGM more accurately than MARD.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparing the correlation between ARD and SMBG values with that between square root index (SRI) and SMBG values.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The CGM (FreeStyle Libre Pro) values and SMBG values which were measured on the same time in the 3 studies in which CGM (FreeStyle Libre Pro) were used. The total 1440 CGM values and 1440 SMBG values
Key exclusion criteria
Judged to be unsuitable for participation for medical reasons
Target sample size
1440
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Soichi Takeishi |
Organization
General Inuyama Chuo Hospital
Division name
Diabetes
Zip code
Address
6, Futagozuka, Goromaru, Inuyama-city, Aichi, Japan.
TEL
0568-62-8111
souichi19811225@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Soichi Takeishi |
Organization
General Inuyama Chuo Hospital
Division name
Diabetes
Zip code
Address
6, Futagozuka, Goromaru, Inuyama-city, Aichi, Japan.
TEL
0568-62-8111
Homepage URL
souichi19811225@yahoo.co.jp
Sponsor or person
Institute
General Inuyama Chuo Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
| 2018 | Year | 01 | Month | 13 | 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 | 12 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 01 | Month | 13 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a cross-sectional study. We analysed the CGM (FreeStyle Libre Pro) values and SMBG values which were measured on the same time in the 3 studies in which CGM (FreeStyle Libre Pro) were used. The total 1440 CGM values and 1440 SMBG values were analysed. We compared the correlation between ARD and SMBG values with that between SRI and SMBG values.
Management information
Registered date
| 2018 | Year | 01 | Month | 13 | Day |
Last modified on
| 2018 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035160
