NCT02809365

FreeStyle Libre- Effect on QOL in Type 2 Diabetes Patients

The Impact on Quality of Life of Novel Glucose -Sensing Technology Used by Individuals With Type 2 Diabetes on Intensive-insulin Therapy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Wolfson Medical Center · Other Government
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized controlled study in type 2 diabetic patients who are presently uncontrolled on at least 2 injections of insulin daily with an A1C \>7.5 % and \<10%. Patients need to be stabilized on their MDI for 1 week then randomized to either SBGM or FreeStyle Libre for 10 weeks.

Detailed description

FreeStyle Libre Flash Glucose Monitoring System is an interstitial glucose monitoring system intended to be replacement for the capillary blood glucose measurement. The system contains several features that distinguish it from exiting sensor technology including no user calibration during 14 days of wear. The sensor is applied to the upper arm of the patient and the hand-held reader is used to scan the sensor to receive glucose result along with historic results with a 15 min frequency for up to 8 hours. An AGP (=Ambulatory Glucose Profile) report is a way to present the glucose data collected by the time of day that has several advantages: demonstrates median glucose levels and the 25-75%, 10-90% excursions as well as the tendency for hypo or hyperglycemia throughout the day. This integration of results gives a more complete picture of the glucose control throughout the week/s while eliminating the "noise" from outliers. The hypothesis is that the addition of FreeStyle Libre system for 10 weeks to the treatment of uncontrolled Type 2 diabetic patients currently on MDI, will produce a modification of behavior/life style and improvement in treatment satisfaction, quality of life and glycemic control and reduce the number of any/major hypoglycemia events.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DEVICE	FreeStyle Libre	Addition of FreeStyle Libre system for 10 weeks to the treatment of uncontrolled Type 2 diabetic patients currently on multiple daily injections
DEVICE	personal glucometer	Subjects in the Control Group will measure blood glucose levels by personal glucometer (SMBG = self monitoring blood glucose)

Timeline

• Start date: 2016-09-01
• Primary completion: 2017-07-31
• Completion: 2017-10-31
• First posted: 2016-06-22
• Last updated: 2017-11-17

Locations

2 sites across 1 country: Israel