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

Diabetes Mellitus Clinical Trial

— LUCID  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01627184
• Other study ID #: PTL-900905
• Status: Completed
• Phase: N/A
• First received: June 21, 2012
• Last updated: February 10, 2015
• Start date: May 2012
• Est. completion date: June 2013

Study information

• Verified date: February 2015
• Source: DexCom, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: June 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Device:
• Dexcom G4 CGM System

Locations

Country	Name	City	State
United States	Atlanta Diabetes Association	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
DexCom, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	multiple months, up to 6	No
Secondary	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	multiple months, up to 6	No