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

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ClinicalTrials.gov Identifier: NCT01627184
Recruitment Status : Completed
First Posted : June 25, 2012
Last Update Posted : February 12, 2015
Sponsor:
Information provided by (Responsible Party):
DexCom, Inc.

Brief 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.

Condition or disease Intervention/treatment
Diabetes Mellitus Device: Dexcom G4 CGM System

Study Type : Observational
Actual Enrollment : 13 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long-term Use: CGM System Assessment in Adult Athletes With Diabetes Mellitus
Study Start Date : May 2012
Actual Primary Completion Date : January 2013
Actual Study Completion Date : June 2013

Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. Glycemic Control during Exercise [ Time Frame: multiple months, up to 6 ]
    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.


Secondary Outcome Measures :
  1. System Utility and Usability [ Time Frame: multiple months, up to 6 ]

    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



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult athletes with diabetes mellitus
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01627184


Locations
United States, Georgia
Atlanta Diabetes Association
Atlanta, Georgia, United States, 30309
Sponsors and Collaborators
DexCom, Inc.

Responsible Party: DexCom, Inc.
ClinicalTrials.gov Identifier: NCT01627184     History of Changes
Other Study ID Numbers: PTL-900905
First Posted: June 25, 2012    Key Record Dates
Last Update Posted: February 12, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases