UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027052
Receipt number R000031008
Scientific Title Correlation between blood glucose level and interstitial glucose level in two subcutaneous continuous glucose monitoring systems in perioperative period
Date of disclosure of the study information 2017/04/18
Last modified on 2018/09/10 14:10:18

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Basic information

Public title

Correlation between blood glucose level and interstitial glucose level in two subcutaneous continuous glucose monitoring systems in perioperative period

Acronym

Correlation between blood glucose level and interstitial glucose level

Scientific Title

Correlation between blood glucose level and interstitial glucose level in two subcutaneous continuous glucose monitoring systems in perioperative period

Scientific Title:Acronym

Correlation between blood glucose level and interstitial glucose level

Region

Japan


Condition

Condition

Patients who are scheduled to undergo neurological, plastic, otorhinolaryngologic, or cardiac surgery

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 during the perioperative period.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Correlation between blood glucose level and interstitial glucose level

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 20 years of age or older, who are scheduled to use arterial pressure monitoring.

Key exclusion criteria

The patients who did not consent to this study

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yuki Sugiyama

Organization

Shinshu University Hospital

Division name

Anesthesiology and Resuscitology

Zip code


Address

3-1-1, Asahi, Matsumoto, Japan

TEL

0263-37-2670

Email

ysugiyama@shinshu-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yuki Sugiyama

Organization

Shinshu University Hospital

Division name

Anesthesiology and Resuscitology

Zip code


Address

3-1-1, Asahi, Matsumoto, Japan

TEL

0263-37-2670

Homepage URL


Email

ysugiyama@shinshu-u.ac.jp


Sponsor or person

Institute

Shinshu University

Institute

Department

Personal name



Funding Source

Organization

Shinshu University

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


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

信州大学医学部附属病院


Other administrative information

Date of disclosure of the study information

2017 Year 04 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

2017 Year 04 Month 03 Day

Date of IRB


Anticipated trial start date

2017 Year 04 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

Bland-Altman analysis
Surveillance error grid analysis


Management information

Registered date

2017 Year 04 Month 18 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=R000031008


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name