UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013338 |
|---|---|
| Receipt number | R000015568 |
| Scientific Title | Accuracy of subcutaneous continuous glucose monitor during perioperative period |
| Date of disclosure of the study information | 2014/03/06 |
| Last modified on | 2016/04/08 12:46:45 |
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Basic information
Public title
Accuracy of subcutaneous continuous glucose monitor during perioperative period
Acronym
Accuracy of subcutaneous continuous glucose monitor
Scientific Title
Accuracy of subcutaneous continuous glucose monitor during perioperative period
Scientific Title:Acronym
Accuracy of subcutaneous continuous glucose monitor
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma, Pancreas tumor, Esophageal cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Aim of this study is examined the accuracy of a subcutaneous continuous glucose monitor during perioperative period.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference between glucose measured by subcutaneous continuous glucose monitor and glucose measured by artificial pancreas.
Key secondary outcomes
Base
Study type
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Subcutaneous continuous glucose monitor
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Schedule operated patient of liver, pancreas and esophagus
Key exclusion criteria
Patients who was not used an artificial pancreas for perioperative glucose control
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Hanazaki |
Organization
Kochi Medical School
Division name
Surgery
Zip code
Address
Kohasu, Oko-cho, Nankoku, Kochi, Japan
TEL
088-880-2370
hanazaki@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoaki Yatabe |
Organization
Kochi Medical School
Division name
Anesthesiology
Zip code
Address
Kohasu, Oko-cho, Nankoku, Kochi, Japan
TEL
088-880-2471
Homepage URL
yatabe@kochi-u.ac.jp
Sponsor or person
Institute
Department of Surgery, Kochi Medical School
Institute
Department
Personal name
Funding Source
Organization
Department of Surgery, Kochi Medical School
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
| 2014 | Year | 03 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/26721825
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
| 2014 | Year | 02 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 03 | 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
Management information
Registered date
| 2014 | Year | 03 | Month | 05 | Day |
Last modified on
| 2016 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015568
