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

NCT ID: NCT01627184

Last Updated: 2015-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

13 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-05-31

Study Completion Date

2013-06-30

Brief Summary

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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

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Conditions

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Diabetes Mellitus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Athletes with diabetes mellitus

Athletes who are insulin-requiring and insulin-dependent diabetics undergoing high levels of activity over extended period of time

Dexcom G4 CGM System

Intervention Type DEVICE

Interventions

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Dexcom G4 CGM System

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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DexCom, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Atlanta Diabetes Association

Atlanta, Georgia, United States

Site Status

Countries

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United States

Other Identifiers

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PTL-900905

Identifier Type: -

Identifier Source: org_study_id

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