UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Accuracy of subcutaneous continuous glucose monitoring system -Comparison between different surgeries-
Title of the study (Brief title)	Accuracy of subcutaneous continuous glucose monitoring system
Region	Japan

Condition
Condition	Patients who were scheduled to undergo neurological or cardiac surgery and healthy volunteers
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 in different surgeries
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Accuracy of subcutaneous continuous glucose monitoring
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 aged 20 years or older who are scheduled to undergo neurosurgery or cardiac surgery, or healthy volunteers
Key exclusion criteria	N/A
Target sample size	90

Research contact person
Name of lead principal investigator	Yuki Sugiyama
Organization	Shinshu Universit School of Medicine
Division name	Department of Anesthesiology and Resuscitology
Address	3-1-1, Asahi, Matsumoto, Nagano
TEL	0263-37-2670
Email	ysugiyama@shinshu-u.ac.jp

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

Sponsor
Institute	Shinshu University School of Medicine Department of Anesthesiology and Resuscitology
Institute
Department

Funding Source
Organization	Shinshu University School of Medicine
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

Other administrative information
Date of disclosure of the study information	2017 Year 09 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 09 Month 08 Day
Anticipated trial start date	2017 Year 09 Month 08 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	Published
URL releasing results
Results
Other related information	none

Management information
Registered date	2017 Year 09 Month 08 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=R000033239