Effectiveness and Safety Study of the Abbott Sensor Based Glucose Monitoring Systems
Public ClinicalTrials.gov record NCT02283411. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Effectiveness and Safety Study of the Abbott Sensor Based Glucose Monitoring System - Personal and Abbott Sensor Based Glucose Monitoring System - Professional
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of the study is to evaluate the safety and effectiveness of the Abbott Sensor Based Glucose Monitoring System Personal (System-P) and Abbott Sensor Based Glucose Monitoring System Professional (System-Pro) when used as an adjunct to blood glucose testing over a 14-day wear period in adult subjects. The Abbott Sensor Based Glucose Monitoring System - Professional Sensors will be worn by adult subjects over a 14-day wear period. The primary objective is to characterize the Systems performance with respect to Yellow Spring Instrument (YSI) reference venous sample measurements. The device performance will be primarily evaluated in terms of point and rate accuracy of the Abbott Sensor Based Glucose Monitoring Systems in reference to YSI. Safety of the Abbott Sensor Based Glucose Monitoring Systems will be characterized by Adverse Device Effects and Serious Adverse Device Effects experienced by study participants. 240 subjects will be enrolled and additional healthy subjects may also be enrolled in the study as training subjects.
Study identification
- NCT ID
- NCT02283411
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 156 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 31, 2014
- Primary completion
- Feb 28, 2015
- Completion
- Feb 28, 2015
- Last update posted
- Feb 21, 2018
2014 – 2015
United States locations
- U.S. sites
- 6
- U.S. states
- 5
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| William Sansum Diabetes Center | Santa Barbara | California | 93105 | — |
| Diablo Clinical Research | Walnut Creek | California | 94598 | — |
| Atlanta Diabetes Associates | Atlanta | Georgia | 30318 | — |
| Rocky Mountain Diabetes & Osteoporosis Center | Idaho Falls | Idaho | 83404 | — |
| Clinical Trials of Texas | San Antonio | Texas | 78229 | — |
| Rainier Clinical Research Center | Renton | Washington | 98057 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02283411, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 21, 2018 · Synced Sep 11, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02283411 live on ClinicalTrials.gov.