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NCT01667185 · ClinicalTrials.gov registry record
Effectiveness and Safety of the Dexcom™ G4 Continuous Glucose Monitoring System in Pediatric Subjects With Diabetes Mellitus
A clinical trial, sponsored by DexCom.
- Completed
- Registry status
- 176
- Enrollment target
NCT01667185: Completed study, sponsored by DexCom.
NCT01667185 is a clinical trial that has completed, run by DexCom. The registered enrollment target is 176 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01667185 has completed, sponsored by DexCom.
- COMPLETED
- Registry status
- 176 participants
- Enrollment target
Study Summary
The primary objective of the study is to evaluate the safety and effectiveness of the G4 System (System) when used as an adjuvant to blood glucose testing over a 7-day period in pediatric subjects with diabetes mellitus. System effectiveness will be primarily evaluated with comparison to laboratory reference Yellow Springs Instrument (YSI) venous sample measurements. The system performance will be evaluated in terms of point and rate accuracy of the system in reference to YSI. The point accuracy is measured as the proportion of G4 System values that are within ±20% of YSI reference value for glucose levels \>80 mg/dL and ±20 mg/dL at YSI glucose levels \<80 mg/dL. The trend accuracy of the device performance, i.e., continuous glucose error grid analysis, will be evaluated as well as the temporal accuracy at different glucose rates of changes and different glucose ranges (hypoglycemic, euglycemic, and hyperglycemic ranges). The primary matched paired (Sensor-YSI) measurements will be collected during one in-clinic session. System effectiveness will also be evaluated with SMBG measurements similarly. Safety data of the system will also be collected and safety will be characterized by the incidence of Adverse Device Effects (ADE) experienced by study participants. Other objectives include the evaluation of device performance at an alternate site (the upper buttocks).
Primary Outcome
The primary objective is to characterize System effectiveness in comparison with the laboratory reference YSI venous sample measurements.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 176 participants |
| Start Date | 2012-07 |
What the finished NCT01667185 record still lists
NCT01667185 is an observational study that tracks outcomes without assigning an intervention. The registered 176 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01667185 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01667185 about?
NCT01667185 is a clinical study titled "Effectiveness and Safety of the Dexcom™ G4 Continuous Glucose Monitoring System in Pediatric Subjects With Diabetes Mellitus". The primary objective of the study is to evaluate the safety and effectiveness of the G4 System (System) when used as an adjuvant to blood glucose testing over a 7-day period in pediatric subjects with diabetes mellitus. System effectiveness will be primarily evaluated with comparison to laboratory...
What is the current status of trial NCT01667185?
This trial is currently completed. The enrollment target is 176 participants. The study started on 2012-07.
Who is sponsoring clinical trial NCT01667185?
This trial is sponsored by DexCom, which has 26 total clinical trials registered on ClinicalTrials.gov.
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