Evaluation of Glycemic Control Using Adjunctive Continuous Glucose Monitoring With the Dexcom G4 System (GLYCOAIM)
This study has been completed.
Sponsor:
DexCom, Inc.
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
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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
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 May 16, 2013