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Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000028251
Receipt No. R000032330
Scientific Title perioperative intensive insulin therapy by continuous glucose monitoring system
Date of disclosure of the study information 2017/07/15
Last modified on 2018/11/14

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Basic information
Public title perioperative intensive insulin therapy by
continuous glucose monitoring system
Acronym perioperative intensive insulin therapy by
continuous glucose monitoring system
Scientific Title perioperative intensive insulin therapy by
continuous glucose monitoring system
Scientific Title:Acronym perioperative intensive insulin therapy by
continuous glucose monitoring system
Region
Japan

Condition
Condition hyperglycemia
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 perioperative blood glucose control by continuous glucose monitoring system
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes perioperative blood glucose change
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 continuous blood glucose monitoring system during perioperative period
Interventions/Control_2 blood glucose control by sliding scale
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 scheduled for surgery with general anesthesia
Key exclusion criteria non
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoji Mita
Organization Tokushima University Hospital
Division name Department of Anesthesiology
Zip code
Address 3-18-15, Kuramoto, Tokushima, Japan
TEL 088-633-7181
Email mita@tokushima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoji Mita
Organization Tokushima University Hospital
Division name Department of Anesthesiology
Zip code
Address 3-18-15, Kuramoto, Tokushima, Japan
TEL 088-633-7181
Homepage URL
Email mita@tokushima-u.ac.jp

Sponsor
Institute Tokushima University
Institute
Department

Funding Source
Organization ministry of education, culture, sports, science and technology-Japan
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 07 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 Suspended
Date of protocol fixation
2016 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 18 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
2017 Year 07 Month 15 Day
Last modified on
2018 Year 11 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032330

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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