Evaluation of Glycemic Control Using Adjunctive Continuous Glucose Monitoring With the Dexcom G4 System
GLYCOAIM
1 other identifier
observational
60
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2012
Shorter than P25 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 21, 2012
CompletedFirst Posted
Study publicly available on registry
June 25, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedFebruary 12, 2013
February 1, 2013
7 months
June 21, 2012
February 11, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluate the Dexcom G4 system utility and usability during home use.
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.
One year
Eligibility Criteria
Adults diagnosed with diabetes mellitus
You may qualify if:
- 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.
You may not qualify if:
- Have extensive skin changes/ diseases that preclude wearing the device.
- Dialysis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- DexCom, Inc.lead
Study Sites (4)
Catalina Research Institute
Chino, California, 91710, United States
Diabetes and Endocrine Associate
La Mesa, California, 91942, United States
Infosphere
West Hills, California, 91307, United States
Desert Endocrinology Clinical Research Center
Henderson, Nevada, 89052, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2012
First Posted
June 25, 2012
Study Start
May 1, 2012
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
February 12, 2013
Record last verified: 2013-02