NCT02082184

An Evaluation of a Novel Glucose Sensing Technology in Type 2 Diabetes

Randomised Controlled Study to Evaluate the Impact of Novel Glucose Sensing Technology on HbA1c in Type 2 Diabetes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 302 (actual)
• Sponsor: Abbott Diabetes Care · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the impact of the Abbott Sensor Based Glucose Monitoring System on glycaemic control (HbA1c) compared to Self Monitoring Blood Glucose (SMBG) testing using a randomised controlled study design in adults with Type 2 diabetes using insulin.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	Sensor Based Glucose Monitoring System	Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels. Post completion of the 6 month intervention, subjects participating in this arm of the study will be given a further 6 month period of open access to the device. All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation.
DEVICE	Standard Blood Glucose Monitoring	Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study. All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation.

Timeline

• Start date: 2014-03-01
• Primary completion: 2015-06-01
• Completion: 2015-12-01
• First posted: 2014-03-10
• Last updated: 2017-05-30
• Results posted: 2017-04-14

Locations

26 sites across 3 countries: France, Germany, United Kingdom