UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029061 |
|---|---|
| Receipt number | R000033239 |
| Scientific Title | Accuracy of subcutaneous continuous glucose monitoring system -Comparison between different surgeries- |
| Date of disclosure of the study information | 2017/09/08 |
| Last modified on | 2018/09/10 14:10:53 |
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Basic information
Public title
Accuracy of subcutaneous continuous glucose monitoring system -Comparison between different surgeries-
Acronym
Accuracy of subcutaneous continuous glucose monitoring system
Scientific Title
Accuracy of subcutaneous continuous glucose monitoring system -Comparison between different surgeries-
Scientific Title:Acronym
Accuracy of subcutaneous continuous glucose monitoring system
Region
| Japan |
Condition
Condition
Patients who were scheduled to undergo neurological or cardiac surgery and healthy volunteers
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the correlation between blood glucose level and interstitial glucose level using subcutaneous continuous glucose monitoring system in different surgeries
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Accuracy of subcutaneous continuous glucose monitoring
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged 20 years or older who are scheduled to undergo neurosurgery or cardiac surgery, or healthy volunteers
Key exclusion criteria
N/A
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuki Sugiyama |
Organization
Shinshu Universit School of Medicine
Division name
Department of Anesthesiology and Resuscitology
Zip code
Address
3-1-1, Asahi, Matsumoto, Nagano
TEL
0263-37-2670
ysugiyama@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuki Sugiyama |
Organization
Shinshu University School of Medicine
Division name
Department of Anesthesiology and Resuscitology
Zip code
Address
3-1-1, Asahi, Matsumoto, Nagano
TEL
0263-37-2670
Homepage URL
ysugiyama@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University School of Medicine
Department of Anesthesiology and Resuscitology
Institute
Department
Personal name
Funding Source
Organization
Shinshu University School of Medicine
Organization
Division
Category of Funding Organization
Other
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 | 09 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Published
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 | 09 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 09 | Month | 08 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2017 | Year | 09 | Month | 08 | Day |
Last modified on
| 2018 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033239
