Evaluation of Glycemic Control Using Adjunctive Continuous Glucose Monitoring With the Dexcom G4 System

NCT ID: NCT01627210

Last Updated: 2013-02-12

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

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-05-31

Study Completion Date

2012-12-31

Brief Summary

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This is a prospective, non-randomized, observational study conducted in the United States.Up to sixty (60) subjects will be enrolled. The purpose of the study is to evaluate long-term utility and usability of Dexcom G4 Continuous Glucose Monitoring (CGM) System. Subjects will be followed monthly over a period of one year.

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

Eligibility Criteria

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Inclusion Criteria

* Require intensive insulin therapy, defined as use of Continuous Subcutaneous Insulin Infusion (CSII) i.e. insulin pumps or multiple daily injections (MDI.
* Willing to refrain from use of any acetaminophen - containing (ACT) medication during the study, up to 24-hours before the initial sensor insertion.

Exclusion Criteria

* Have extensive skin changes/ diseases that preclude wearing the device.
* 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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Catalina Research Institute

Chino, California, United States

Site Status

Diabetes and Endocrine Associate

La Mesa, California, United States

Site Status

Infosphere

West Hills, California, United States

Site Status

Desert Endocrinology Clinical Research Center

Henderson, Nevada, United States

Site Status

Countries

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United States

Other Identifiers

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PTL900920

Identifier Type: -

Identifier Source: org_study_id

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