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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.

June 21, 2012
June 25, 2012
February 12, 2015
May 2012
January 2013   (Final data collection date for primary outcome measure)
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.
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.
Complete list of historical versions of study NCT01627184 on ClinicalTrials.gov Archive Site
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
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
Not Provided
Not Provided
 
Long-term Use: CGM System Assessment in Adult Athletes With Diabetes Mellitus
Long-term Use: CGM System Assessment in Adult Athletes With Diabetes Mellitus
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Adult athletes with diabetes mellitus
Diabetes Mellitus
Device: Dexcom G4 CGM System
Athletes with diabetes mellitus
Athletes who are insulin-requiring and insulin-dependent diabetics undergoing high levels of activity over extended period of time
Intervention: Device: Dexcom G4 CGM System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
15
June 2013
January 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01627184
PTL-900905
No
Not Provided
Not Provided
DexCom, Inc.
DexCom, Inc.
Not Provided
Not Provided
DexCom, Inc.
February 2015