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CompletedNCT01627184LUCIDUpdated Feb 12, 2015

Long-term Use: CGM System Assessment in Adult Athletes With Diabetes Mellitus

An observational study in Diabetes Mellitus, sponsored by DexCom, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-02-12.

Sponsored by DexCom, Inc. · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
13
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to evaluate CGM glycemic control using the Dexcom G4 system as well as system performance during high levels of activity and home use by adult athletes with insulin-requiring diabetes mellitus, over an extended period of time.

02

Conditions studied

  • Diabetes Mellitus

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03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 13 is below the median of 233 across 2,220 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.

04

Who can participate

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

Study population

Adult athletes with diabetes mellitus

Inclusion criteria

  1. Age 18 years or older
  2. Diagnosis of diabetes mellitus

Exclusion criteria

Exclusion Criteria:

  1. Extensive skin changes/diseases
  2. Known allergy to medical adhesives
  3. Pregnancy
  4. Dialysis
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
13 participants (actual)

Groups and cohorts

  • Athletes with diabetes mellitus

    Athletes who are insulin-requiring and insulin-dependent diabetics undergoing high levels of activity over extended period of time

    Device: Dexcom G4 CGM System

Interventions

  • DeviceDexcom G4 CGM System
06

What researchers measure

Primary outcomes

  1. Glycemic Control during Exercise

    The proportion of time spent in euglycemia zone as well as hypoglycemia zone will be determined from the system glucose readings, particularly during subject's high levels of activity. Longitudinal data analysis methods will be used to assess the within-subject and between-subject effects of the glycemic control for the study population.

    Time frame: multiple months, up to 6

Secondary outcomes

  1. System Utility and Usability

    The objectives of the study are to evaluate the Dexcom G4 system utility and usability during high levels of activity and home use. The assessments may be evaluated by, but are not limited to, the following: * Number and duration of sensors used by subject * Percentage of CGM system communication during wear * Percentage of CGM system glucose reading during wear * Incidence of System prompts and error messages recorded in the receiver

    Time frame: multiple months, up to 6

07

Study locations

1 site
  • Atlanta Diabetes Association
    Atlanta, Georgia 30309, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 12, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01627184
Lead sponsor
DexCom, Inc.
Responsible party
Sponsor
First posted
Jun 25, 2012
Start date
May 2012
Primary completion
Jan 2013
Completion
Jun 2013
Last update
Feb 12, 2015

Oversight

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

Not currently enrolling

This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.

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