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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003733
Receipt No. R000004522
Scientific Title Automatic insulin therapy in critically ill patients; Randmized cross-over controlled study
Date of disclosure of the study information 2010/06/15
Last modified on 2012/12/10

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Basic information
Public title Automatic insulin therapy in critically ill patients; Randmized cross-over controlled study
Acronym Automatic insulin therapy in critically ill patients
Scientific Title Automatic insulin therapy in critically ill patients; Randmized cross-over controlled study
Scientific Title:Acronym Automatic insulin therapy in critically ill patients
Region
Japan

Condition
Condition Adult ICU patients expected to stay for more than 3 days and had acute hyperglycemia defined as >150 mg/dL
Classification by specialty
Emergency medicine Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the safety and efficacy of automatic insulin therapy using STG-22, especially on the incidence of hypoglycemia, the achievement of target glucose levels, glycemic variability and oxidative stress.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The achievement of target blood glucose levels.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit
Blinding Open -no one is 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 Automatic insulin therapy using STG-22
Interventions/Control_2 Protocol based insulin therapy
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 Adult ICU patients
expected to stay in ICU for more than 3 days
glucose level>150mgdL
Key exclusion criteria Prediagnosed diabetic melitus
Contraindication of insulin
Target sample size 24

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Moritoki Egi
Organization Okayama University Hospital
Division name Department of Anesthesiology and Resuscitology
Zip code
Address 2-5-1 Shikata tyou Okayama city, Okayama, Japan 700-8558
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Okayama University Hospital
Division name Department of Anesthesiology and Resuscitology
Zip code
Address
TEL 086-235-7778
Homepage URL
Email

Sponsor
Institute Department of Anesthesiology and Resuscitology, Okayama University Hospital
Institute
Department

Funding Source
Organization Japan Society of the Promotion of Science
Organization
Division
Category of Funding Organization
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

Other administrative information
Date of disclosure of the study information
2010 Year 06 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
2009 Year 12 Month 28 Day
Date of IRB
Anticipated trial start date
2010 Year 06 Month 01 Day
Last follow-up date
2012 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 06 Month 10 Day
Last modified on
2012 Year 12 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004522

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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