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

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.

FreeStyle Libre users: 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.

Self monitoring blood glucose: patients in this arm will measure blood glucose with personal glucometer

Addition of FreeStyle Libre system for 10 weeks to the treatment of uncontrolled Type 2 diabetic patients currently on multiple daily injections

Subjects in the Control Group will measure blood glucose levels by personal glucometer (SMBG = self monitoring blood glucose)

Improvement of diabetes treatment satisfaction measured by the 'Diabetes Treatment Satisfaction Questionnaire' (DTSQ)

This outcome will be measured by a validated diabetes - specific quality of life questionnaire (DQOL).

This outcome will be measure by a questionnaire developed by the investigators using specific items evaluating the use of the Libre System.

By comparing events of glucose levels below 54 mg% in the intervention group versus the control group.

By comparing events of glucose levels below 70 mg% in the intervention group versus the control group.

Inclusion Criteria: Type 2 diabetes - more than 1 year Age: 30 - 80 yrs Treated with MDI: ≥ 2 injections daily HbA1c: 7.5% to 10% Willing to measure 7 daily blood tests at least one day each week Willing to sign informed consent Exclusion Criteria: Type 1 diabetes CV event within the last 6 months Steroid therapy > 7 days in last 6 months Retinopathy - grade 3 Creatinine >2 mg%

Yaron M, Roitman E, Aharon-Hananel G, Landau Z, Ganz T, Yanuv I, Rozenberg A, Karp M, Ish-Shalom M, Singer J, Wainstein J, Raz I. Effect of Flash Glucose Monitoring Technology on Glycemic Control and Treatment Satisfaction in Patients With Type 2 Diabetes. Diabetes Care. 2019 Jul;42(7):1178-1184. doi: 10.2337/dc18-0166. Epub 2019 Apr 29.