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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:
Information provided by (Responsible Party):
DexCom, Inc.
ClinicalTrials.gov Identifier:
NCT01627210
First received: June 21, 2012
Last updated: February 11, 2013
Last verified: February 2013

June 21, 2012
February 11, 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 ] [ Designated as safety issue: No ]
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.

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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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01627210
PTL900920
No
DexCom, Inc.
DexCom, Inc.
Not Provided
Not Provided
DexCom, Inc.
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP