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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
DexCom, Inc.
ClinicalTrials.gov Identifier:
NCT01627210
First received: June 21, 2012
Last updated: February 11, 2013
Last verified: February 2013
  Purpose

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.


Condition
Diabetes Mellitus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Glycemic Control Using Adjunctive Continuous Glucose Monitoring With the Dexcom G4 System - GLYCOAIM Study

Resource links provided by NLM:


Further study details as provided by DexCom, Inc.:

Primary Outcome Measures:
  • Evaluate the Dexcom G4 system utility and usability during home use. [ Time Frame: One year ] [ Designated as safety issue: No ]
    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.


Enrollment: 60
Study Start Date: May 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adults diagnosed with diabetes mellitus

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01627210

Locations
United States, California
Catalina Research Institute
Chino, California, United States, 91710
Diabetes and Endocrine Associate
La Mesa, California, United States, 91942
Infosphere
West Hills, California, United States, 91307
United States, Nevada
Desert Endocrinology Clinical Research Center
Henderson, Nevada, United States, 89052
Sponsors and Collaborators
DexCom, Inc.
  More Information

No publications provided

Responsible Party: DexCom, Inc.
ClinicalTrials.gov Identifier: NCT01627210     History of Changes
Other Study ID Numbers: PTL900920
Study First Received: June 21, 2012
Last Updated: February 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by DexCom, Inc.:
Diabetes Mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 26, 2014