Type 2 Diabetes Clinical Trial
Official title:
The Impact on Quality of Life of Novel Glucose -Sensing Technology Used by Individuals With Type 2 Diabetes on Intensive-insulin Therapy
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.
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.
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