NCT02336945

Glucose Variability Pilot Study for the Abbott Sensor Based Glucose Monitoring System-Professional

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 146 (actual)
• Sponsor: Abbott Diabetes Care · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	Abbott Sensor Based Glucose Monitoring System-Professional	Subjects will wear 2 glucose sensors while going about daily activities and adhering to establish diabetes treatment plan. This is not a treatment study.

Timeline

• Start date: 2015-01-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2015-01-13
• Last updated: 2017-01-24

Locations

7 sites across 1 country: United States