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Continuous Glucose Monitoring System in Intensive Care Unit

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01995994
Recruitment Status : Completed
First Posted : November 27, 2013
Last Update Posted : May 21, 2015
Sponsor:
Information provided by (Responsible Party):
Jin-Tae Kim, Seoul National University Hospital

Tracking Information
First Submitted Date November 21, 2013
First Posted Date November 27, 2013
Last Update Posted Date May 21, 2015
Study Start Date June 2012
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 26, 2013)
Difference between finger stick blood glucose and real-time continuous glucose monitoring [ Time Frame: 72 hours ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 26, 2013)
Measurement error of real-time continuous glucose monitoring [ Time Frame: 72 hours ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Continuous Glucose Monitoring System in Intensive Care Unit
Official Title Continuous Glucose Monitoring System in Intensive Care Unit - Preliminary Study Evaluating Accuracy
Brief Summary To assess the accuracy, safety, and influence of sampling site of Real-time continuous glucose monitoring system (Medtronic Guardian).
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients planned to stay in intensive care units longer than 72 hours
Condition Diabetic Blood Glucose Monitoring
Intervention Not Provided
Study Groups/Cohorts RT-CGM
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 19, 2015)
23
Original Estimated Enrollment
 (submitted: November 26, 2013)
30
Actual Study Completion Date February 2014
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Older than 18 years old
  • Staying in intensive care units longer than 72 hours

Exclusion Criteria:

  • Skin disease
  • DIC
  • Immune suppressed patients
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT01995994
Other Study ID Numbers D-1203-106-404
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Jin-Tae Kim, Seoul National University Hospital
Study Sponsor Seoul National University Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Jin-Tae Kim, MD. PhD. Seoul National University Hospital
PRS Account Seoul National University Hospital
Verification Date November 2013