This is a multi-center, prospective, non-pivotal, single arm, non-significant risk evaluation the Abbott Sensor Based Glucose Monitoring System - Pro across different stages of T2 diabetes management. This is a non-significant risk study.
Subjects will wear two Sensors, one applied to the back of each upper arm, for a period of 14 days. Subjects will wear the Sensor while going about their normal daily activities during the home use period. Subjects will not be able to see any glucose data. The devices will be removed at the completion of the final study visit. Data obtained from the Reader and reports generated by the system will not be used by the subject or the research team members to determine treatment. Subjects must adhere to their diabetes clinical management plan established prior to the study. No additional medical care will be provided to study subjects following study completion other than care related to the follow up and treatment of adverse events.
Study Type
OBSERVATIONAL
Enrollment
146
Subjects will wear 2 glucose sensors while going about daily activities and adhering to establish diabetes treatment plan. This is not a treatment study.
Unger Primary Care Medical Center & Catalina Research Institute
Chino, California, United States
Dr. Deanna Cheung
Long Beach, California, United States
University of California San Diego Veterns Affairs Medical Center
San Diego, California, United States
Henry Ford Medical Center
Detroit, Michigan, United States
Glucose variability as measured by AGP Interquartile Range, (IQR) obtained via System-Pro Sensor.
Time frame: 2 weeks
Assessment of ambulatory glucose profiles (AGPs) generated by the Software
Time frame: 2 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
St. Luke's Endocrinology and Diabetes
Kansas City, Missouri, United States
Duke Southern Regional AHEC
Fayetteville, North Carolina, United States
Diabetes America- Pearland
Pearland, Texas, United States