UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028251
Receipt number 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 2022/02/20 22:00:47

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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 Naoji
Middle name
Last name Mita

Organization

Tokushima University Hospital

Division name

Department of Anesthesiology

Zip code

770-8503

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 Naoji
Middle name
Last name Mita

Organization

Tokushima University Hospital

Division name

Department of Anesthesiology

Zip code

770-8503

Address

3-18-15, Kuramoto, Tokushima, Japan

TEL

088-633-7181

Homepage URL


Email

mita@tokushima-u.ac.jp


Sponsor or person

Institute

Tokushima University

Institute

Department

Personal name



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

Institutional Review Board,Tokushima University Hospital

Address

2-50-1, Kuramoto-tyo, Tokushima, Japan

Tel

088-633-9294

Email

first-ec@tokushima-u.ac.jp


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

Completed

Date of protocol fixation

2016 Year 04 Month 01 Day

Date of IRB

2016 Year 06 Month 01 Day

Anticipated trial start date

2016 Year 07 Month 18 Day

Last follow-up date

2022 Year 12 Month 31 Day

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

2022 Year 02 Month 20 Day



Link to view the page

Value
https://center6.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