UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012309 |
|---|---|
| Receipt number | R000014394 |
| Scientific Title | Continuous blood glucose monitoring by artificial pancreas during interventional radiology |
| Date of disclosure of the study information | 2013/11/18 |
| Last modified on | 2017/02/10 18:45:31 |
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Basic information
Public title
Continuous blood glucose monitoring by artificial pancreas during interventional radiology
Acronym
Blood Glucose Monitoring by Artificial Pancreas -InterVentional Radiology (GMAP-IVR)
Scientific Title
Continuous blood glucose monitoring by artificial pancreas during interventional radiology
Scientific Title:Acronym
Blood Glucose Monitoring by Artificial Pancreas -InterVentional Radiology (GMAP-IVR)
Region
| Japan |
Condition
Condition
Patients treated intra- and extracranial diseases (aneurysms, arterial stenosis, and tumors, etc.)with interventional radiology
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study evaluates that continuous blood glucose monitoring by artificial pancreas detects adverse events during interventional radiology by blood glucose change.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between blood glucose change and adverse event during IVR
Key secondary outcomes
Correlation between hypreintense lesions on postoperative diffusion weighted images and blood glucose change
Correlation between change of cerebral blood flow on postoperative SPECT and blood glucose change
Incidence of unmeasurable events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
During IVR, blood glucose is continuously monitored by artificial pancreas. Blood is sampled at a 2mL/hr from peripheral vein.
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
Diseases required IVR
Men and women of 20 years of age or older
Unnecessary of insulin treatment
Written Informed consent
Key exclusion criteria
Necessary of insulin treatment
Requirement of glucose administration before and during surgery
Pregnant or lactating women and women of child bearing potential
Patients judged by investigators ineligible for participation as study subjects for any other reason.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shin-Ichi Miyatake |
Organization
Osaka Medical College
Division name
Neurosurgery
Zip code
Address
2-7, Daigakumachi, Takatsuki, Osaka, 569-8686, Japan
TEL
072-683-1221
neu070@poh.osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Motomasa Furuse |
Organization
Osaka Medical College
Division name
Neurosurgery
Zip code
Address
2-7, Daigakumachi, Takatsuki, Osaka, 569-8686, Japan
TEL
072-683-1221
Homepage URL
neu054@poh.osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
Department of Neurosurgery, Osaka Medical College
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
| 2013 | Year | 11 | Month | 18 | 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
| 2013 | Year | 07 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | Month | 27 | Day |
Last follow-up date
| 2016 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 11 | Month | 15 | Day |
Last modified on
| 2017 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014394
