UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Continuous Glucose Monitoring(CGM) in Acute Ischemic Stroke
Title of the study (Brief title)	Continuous Glucose Monitoring(CGM) in Acute Ischemic Stroke
Region	Japan

Condition
Condition	Acute Stroke
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to examine the effect of continuous glucose level to the infarct expansion and clinical outcome in acute stroke.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Clinical outcome,NIHSS score,complication the volume of infarction on DWI Hemorrhagic infarction on T2*
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Continuous Glucose Monitoring
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	Acute stroke patients on 24h onset
Key exclusion criteria	t-PA therapy, endovascular therapy, evacuation of the hematoma
Target sample size	100

Research contact person
Name of lead principal investigator	Takashi Shimoyama
Organization	Kawasaki Medical School
Division name	Department of Stroke Medicine
Address	577 Matsushima, Kurashiki City, Okayama, 701-0192, Japan
TEL
Email

Public contact
Name of contact person
Organization	Kawasaki Medical School
Division name	Department of Stroke Medicine
Address	577 Matsushima, Kurashiki City, Okayama, 701-0192, Japan
TEL	086-462-1111
Homepage URL
Email

Sponsor
Institute	Department of Stroke Medicine, Kawasaki Medical School
Institute
Department

Funding Source
Organization	Department of Stroke Medicine, Kawasaki Medical School
Organization
Division
Category of Funding Organization	Self funding
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	2011 Year 05 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 05 Month 30 Day
Anticipated trial start date	2011 Year 06 Month 01 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

Management information
Registered date	2011 Year 05 Month 24 Day
Last modified on	2016 Year 11 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006660