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Evaluation of Glycemic Control Using Adjunctive Continuous Glucose Monitoring With the Dexcom G4 System (GLYCOAIM)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01627210
First Posted: June 25, 2012
Last Update Posted: February 12, 2013
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.
Information provided by (Responsible Party):
DexCom, Inc.
June 21, 2012
June 25, 2012
February 12, 2013
May 2012
December 2012   (Final data collection date for primary outcome measure)
Evaluate the Dexcom G4 system utility and usability during home use. [ Time Frame: One year ]
The primary object of the study is to evaluate the Dexcom G4 system utility and usability during home use. Variables to be evaluated are sensor used, length of use, and data capture during use.
Same as current
Complete list of historical versions of study NCT01627210 on ClinicalTrials.gov Archive Site
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Evaluation of Glycemic Control Using Adjunctive Continuous Glucose Monitoring With the Dexcom G4 System
Evaluation of Glycemic Control Using Adjunctive Continuous Glucose Monitoring With the Dexcom G4 System - GLYCOAIM Study
This is a prospective, non-randomized, observational study conducted in the United States.Up to sixty (60) subjects will be enrolled. The purpose of the study is to evaluate long-term utility and usability of Dexcom G4 Continuous Glucose Monitoring (CGM) System. Subjects will be followed monthly over a period of one year.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
Adults diagnosed with diabetes mellitus
Diabetes Mellitus
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
December 2012
December 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Require intensive insulin therapy, defined as use of Continuous Subcutaneous Insulin Infusion (CSII) i.e. insulin pumps or multiple daily injections (MDI.
  • Willing to refrain from use of any acetaminophen - containing (ACT) medication during the study, up to 24-hours before the initial sensor insertion.

Exclusion Criteria:

  • Have extensive skin changes/ diseases that preclude wearing the device.
  • Dialysis.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01627210
PTL900920
No
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DexCom, Inc.
DexCom, Inc.
Not Provided
Not Provided
DexCom, Inc.
February 2013