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

Completed

• Conditions: Diabetes Mellitus
• Interventions: Device: Dexcom G4 CGM System

• Registration Number: NCT01627184
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-06-21
• Study First Submitted QC: 2012-06-22
• Study First Posted: 2012-06-25
• Primary Completion: 2013-01
• Study Completion: 2013-06
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-10
• Last Update Posted: 2015-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Athletes with diabetes mellitus	Dexcom G4 CGM System	Athletes who are insulin-requiring and insulin-dependent diabetics undergoing high levels of activity over extended period of time

Primary Outcome Measures

Name	Time	Method
Glycemic Control during Exercise	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

Name	Time	Method
System Utility and Usability	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

Trial Locations

Locations (1)

Atlanta Diabetes Association; 🇺🇸 Atlanta, Georgia, United States