FreeStyle Libre- Effect on QOL in Type 2 Diabetes Patients

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Device: FreeStyle Libre
* Device: personal glucometer


Participation Criteria
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Eligibility Criteria
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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%

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Libre<br>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. | Device: FreeStyle Libre<br>* Addition of FreeStyle Libre system for 10 weeks to the treatment of uncontrolled Type 2 diabetic patients currently on multiple daily injections<br>|
| Other: SMBG<br>Self monitoring blood glucose: patients in this arm will measure blood glucose with personal glucometer | Device: personal glucometer<br>* Subjects in the Control Group will measure blood glucose levels by personal glucometer (SMBG = self monitoring blood glucose)<br>* Other names: SMBG;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of diabetes treatment satisfaction measured by the 'Diabetes Treatment Satisfaction Questionnaire' (DTSQ) |  | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of quality of life. | This outcome will be measured by a validated diabetes - specific quality of life questionnaire (DQOL). | 10 weeks | 
| Assessment of satisfaction from the FreeStyle Libre system | This outcome will be measure by a questionnaire developed by the investigators using specific items evaluating the use of the Libre System. | 10 weeks | 
| Improvement of HbA1c | This outcome will be measured in capillary blood sample. | 10 weeks | 
| Percent to reach target HbA1c as defined personally by the physician | This outcome will be assessed using the result of the HbA1c. | 10 weeks | 
| Reduction in hypoglycemic events <54 mg% | By comparing events of glucose levels below 54 mg% in the intervention group versus the control group. | 10 weeks | 
| Reduction in hypoglycemic events <70 mg% | By comparing events of glucose levels below 70 mg% in the intervention group versus the control group. | 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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insulin treated