UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Correlation between blood glucose level and interstitial glucose level in two subcutaneous continuous glucose monitoring systems in perioperative period
Title of the study (Brief title)	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	Yuki Sugiyama
Organization	Shinshu University Hospital
Division name	Anesthesiology and Resuscitology
Address	3-1-1, Asahi, Matsumoto, Japan
TEL	0263-37-2670
Email	ysugiyama@shinshu-u.ac.jp

Public contact
Name of contact person	Yuki Sugiyama
Organization	Shinshu University Hospital
Division name	Anesthesiology and Resuscitology
Address	3-1-1, Asahi, Matsumoto, Japan
TEL	0263-37-2670
Homepage URL
Email	ysugiyama@shinshu-u.ac.jp

Sponsor
Institute	Shinshu University
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 04 Month 03 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031008