Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01514305 · ClinicalTrials.gov registry record
Observational Study to Evaluate the Effectiveness and Safety Study of the Dexcom G4™ Continuous Glucose Monitoring System
A clinical trial, sponsored by DexCom.
- Completed
- Registry status
- 21
- Enrollment target
NCT01514305: Completed study, sponsored by DexCom.
NCT01514305 is a clinical trial that has completed, run by DexCom. The registered enrollment target is 21 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01514305 has completed, sponsored by DexCom.
- COMPLETED
- Registry status
- 21 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the effectiveness and safety of the Dexcom G4 System when used as an adjuvant to blood glucose testing. Device performance will be primarily evaluated in terms of the proportion of glucose values within a pre-specified range compared to reference values. Safety data of the G4 System will also be collected vis-a-vis adverse event reporting characterized by the incidence and severity of Serious Adverse Device Events, and Adverse Device Events experienced by study participants.
Primary Outcome
The primary objective is to characterize the System performance with respect to laboratory reference venous sample measurements. The device performance will be primarily evaluated in terms of point and rate accuracy of the G4 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.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2011-11 |
| Est. Completion | 2011-12 |
What the finished NCT01514305 record still lists
NCT01514305 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 21 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01514305 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01514305 about?
NCT01514305 is a clinical study titled "Observational Study to Evaluate the Effectiveness and Safety Study of the Dexcom G4™ Continuous Glucose Monitoring System". The purpose of this study is to evaluate the effectiveness and safety of the Dexcom G4 System when used as an adjuvant to blood glucose testing. Device performance will be primarily evaluated in terms of the proportion of glucose values within a pre-specified range compared to reference values. Sa...
What is the current status of trial NCT01514305?
This trial is currently completed. The enrollment target is 21 participants. The study started on 2011-11. Estimated completion is 2011-12.
Who is sponsoring clinical trial NCT01514305?
This trial is sponsored by DexCom, which has 26 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02447874 · 21 participants · Phase 1
Arginine Therapy for the Treatment of Pain in Children With Sickle Cell Disease
- NCT03826992 · 21 participants · Phase 1
Venetoclax Combined With Vyxeos (CPX-351) for Participants With Relapsed or Refractory Acute Leukemia
- NCT04107077 · 21 participants · Phase 2
Phase II Study of the Effects of Laparoscopic Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Patients With Advanced Gastric Cancer
- NCT04158635 · 21 participants · Phase 1
Gemcitabine, Nab-Paclitaxel, and Bosentan for the Treatment of Unresectable Pancreatic Cancer
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia