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

• Sponsor: DexCom, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01627184
• Collaborator: (none)
• Enrollment: 13
• Location: 1
• Duration (Months): 13
• Patients Per Site Per Month: 1

Study Details

Study Description

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	Phase
Diabetes Mellitus	Device: Dexcom G4 CGM System

Study Design

• 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 1, 2012
• Actual Primary Completion Date: Jan 1, 2013
• Actual Study Completion Date: Jun 1, 2013

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Atlanta Diabetes Association	Atlanta	Georgia	United States	30309

Sponsors and Collaborators

• DexCom, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: DexCom, Inc.
• ClinicalTrials.gov Identifier: NCT01627184
• Other Study ID Numbers: PTL-900905
• First Posted: Jun 25, 2012
• Last Update Posted: Feb 12, 2015
• Last Verified: Feb 1, 2015

• Additional relevant MeSH terms: Diabetes Mellitus

Study Results

No Results Posted as of Feb 12, 2015