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

History of Changes

Tracking Information
First Received Date ^ICMJE	June 21, 2012
Last Updated Date	February 11, 2013
Start Date ^ICMJE	May 2012
Primary Completion Date	December 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 22, 2012)	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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01627210 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Evaluation of Glycemic Control Using Adjunctive Continuous Glucose Monitoring With the Dexcom G4 System
Official Title ^ICMJE	Evaluation of Glycemic Control Using Adjunctive Continuous Glucose Monitoring With the Dexcom G4 System - GLYCOAIM Study
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Adults diagnosed with diabetes mellitus
Condition ^ICMJE	Diabetes Mellitus
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Not Provided
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 ^ICMJE	Completed
Enrollment ^ICMJE	60
Completion Date	December 2012
Primary Completion Date	December 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01627210
Other Study ID Numbers ^ICMJE	PTL900920
Has Data Monitoring Committee	No
Responsible Party	DexCom, Inc.
Study Sponsor ^ICMJE	DexCom, Inc.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	DexCom, Inc.
Verification Date	February 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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