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

February 10, 2015 updated by: DexCom, Inc.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

13

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Atlanta Diabetes Association

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult athletes with diabetes mellitus

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
multiple months, up to 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
multiple months, up to 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DexCom, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

June 21, 2012

First Submitted That Met QC Criteria

June 22, 2012

First Posted (Estimate)

June 25, 2012

Study Record Updates

Last Update Posted (Estimate)

February 12, 2015

Last Update Submitted That Met QC Criteria

February 10, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PTL-900905

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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