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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
DexCom, Inc.
ClinicalTrials.gov Identifier:
NCT01627184
First received: June 21, 2012
Last updated: February 10, 2015
Last verified: February 2015
  Purpose

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 Intervention
Diabetes Mellitus
Device: Dexcom G4 CGM System

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long-term Use: CGM System Assessment in Adult Athletes With Diabetes Mellitus

Further study details as provided by DexCom, Inc.:

Primary Outcome Measures:
  • Glycemic Control during Exercise [ Time Frame: multiple months, up to 6 ] [ Designated as safety issue: No ]
    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:
  • System Utility and Usability [ Time Frame: multiple months, up to 6 ] [ Designated as safety issue: No ]

    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


Enrollment: 13
Study Start Date: May 2012
Study Completion Date: June 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01627184

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

No publications provided

Responsible Party: DexCom, Inc.
ClinicalTrials.gov Identifier: NCT01627184     History of Changes
Other Study ID Numbers: PTL-900905
Study First Received: June 21, 2012
Last Updated: February 10, 2015
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 30, 2015