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NCT01627210 Clinical Trial

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

Diabetes Mellitus Clinical Trial

— GLYCOAIM  

Official title:
Evaluation of Glycemic Control Using Adjunctive Continuous Glucose Monitoring With the Dexcom G4 System - GLYCOAIM Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01627210
Other study ID # PTL900920
Secondary ID
Status Completed
Phase N/A
First received June 21, 2012
Last updated February 11, 2013
Start date May 2012
Est. completion date December 2012

Study information
Verified date February 2013
Source DexCom, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Catalina Research Institute Chino California
United States Desert Endocrinology Clinical Research Center Henderson Nevada
United States Diabetes and Endocrine Associate La Mesa California
United States Infosphere West Hills California

Sponsors (1)
Lead Sponsor Collaborator
DexCom, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluate the Dexcom G4 system utility and usability during home use. The primary object of the study is to evaluate the Dexcom G4 system utility and usability during home use. Variables to be evaluated are sensor used, length of use, and data capture during use. One year No
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