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G5® Mobile Continuous Glucose Monitoring System Automated vs. Manual Sensor Applicator

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: NCT02696252
Recruitment Status : Completed
First Posted : March 2, 2016
Last Update Posted : April 14, 2016
Sponsor:
Information provided by (Responsible Party):
DexCom, Inc.

Tracking Information
First Submitted Date January 25, 2016
First Posted Date March 2, 2016
Last Update Posted Date April 14, 2016
Study Start Date January 2016
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 25, 2016)
proportion of blood glucose values, compared between CGM and a lab glucose analyzer that are matched relative to a diabetes accuracy measurement of %20/20 mg/dL [ Time Frame: 7 days ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title G5® Mobile Continuous Glucose Monitoring System Automated vs. Manual Sensor Applicator
Official Title Comparison of G5® Mobile Continuous Glucose Monitoring System Accuracy When Using an Automated Applicator vs. a Manual Sensor Applicator
Brief Summary Comparison of G5® Mobile Continuous Glucose Monitoring System Accuracy When Using an Automated Applicator vs. a Manual Sensor Applicator
Detailed Description The objective of the study is to demonstrate the performance, i.e. efficacy of the G5x System with the automated applicator is no worse than that of the commercial Dexcom G4 TM PLATINUM Continuous Glucose Monitoring System (G4 System) with the manual applicator.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adults and pediatrics with diabetes mellitus
Condition Diabetes Mellitus
Intervention Not Provided
Study Groups/Cohorts CGM Users
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 13, 2016)
97
Original Estimated Enrollment
 (submitted: February 25, 2016)
60
Actual Study Completion Date April 2016
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Ages 2 or older
  • Diagnosis of Type 1 diabetes or Type 2 diabetes
  • Willing to participate in a clinic session involving venous sampling for evaluation of study end point

Exclusion Criteria:

  • Use of acetaminophen
  • Known allergy to medical-grade adhesives
  • Pregnancy
  • Hematocrit outside specification of the study-assigned blood glucose meter
Sex/Gender
Sexes Eligible for Study: All
Ages 2 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02696252
Other Study ID Numbers PTL-901800
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party DexCom, Inc.
Study Sponsor DexCom, Inc.
Collaborators Not Provided
Investigators Not Provided
PRS Account DexCom, Inc.
Verification Date April 2016