Effectiveness and Safety Study of the DexCom™ G4 Continuous Glucose Monitoring System in Children and Adolescents With Type 1 Diabetes Mellitus
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01185496|
Recruitment Status : Completed
First Posted : August 20, 2010
Last Update Posted : June 13, 2011
|Condition or disease|
Device performance will be primarily evaluated in terms of the proportion of G4 System values that are within ±20% of the study meter reference value for glucose levels >80 mg/dL and ±20 mg/dL at meter glucose levels <80 mg/dL. This proportion will be compared to the proportion of such points observed in the DexCom clinical study that will be used to apply for FDA approval of the G4 System (PTL 900360) for adults.
Safety data of the G4 System will also be collected and safety will be characterized by the incidence of Adverse Device Effects, Serious Adverse Device Events, and Unanticipated Adverse Device Effects experienced by study participants.
|Study Type :||Observational|
|Estimated Enrollment :||64 participants|
|Official Title:||Effectiveness and Safety Study of the DexCom™ G4 Continuous Glucose Monitoring System in Children and Adolescents With Type 1 Diabetes Mellitus|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||October 2010|
|Actual Study Completion Date :||November 2010|
Blinded/Unblinded CGM wear in adjunct with SMBG meter diabetes management
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01185496
|United States, California|
|San Diego, California, United States, 92121|