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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Atlanta Diabetes Association

Atlanta, Georgia, 30309, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age 18 years or older
Diagnosis of diabetes mellitus

Exclusion criteria

Extensive skin changes/diseases
Known allergy to medical adhesives
Pregnancy
Dialysis

Treatment and study plan

Dexcom G4 CGM System

Device

Primary outcomes

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.

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

DexCom, Inc.

Industry

Registry information

Acronym: LUCID

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: Jun 25, 2012
Registry last updated: Feb 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed