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CompletedNCT01627210GLYCOAIMUpdated Feb 12, 2013

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

An observational study in Diabetes Mellitus, sponsored by DexCom, Inc.. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-02-12.

Sponsored by DexCom, Inc. · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Diabetes Mellitus

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Keywords

  • Diabetes Mellitus
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.

This study's enrollment of 60 is below the median of 233 across 2,218 observational studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

DexCom, Inc. is the lead sponsor of 35 studies on the registry; 1 is open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adults diagnosed with diabetes mellitus

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

Exclusion Criteria:

  • Have extensive skin changes/ diseases that preclude wearing the device.
  • Dialysis.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (actual)
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What researchers measure

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.

    Time frame: One year

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Study locations

4 sites
  • 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
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 12, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01627210
Lead sponsor
DexCom, Inc.
Responsible party
Sponsor
First posted
Jun 25, 2012
Start date
May 2012
Primary completion
Dec 2012
Completion
Dec 2012
Last update
Feb 12, 2013

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.

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