FreeStyle Libre- Effect on QOL in Type 2 Diabetes Patients

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02809365
• Other study ID #: 0096-16-WOMC
• Status: Completed
• Phase: N/A
• First received: June 8, 2016
• Last updated: November 15, 2017
• Start date: September 2016
• Est. completion date: October 31, 2017

Study information

• Verified date: November 2017
• Source: Wolfson Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 31, 2017
• Est. primary completion date: July 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Type 2 diabetes - more than 1 year

2. Age: 30 - 80 yrs

3. Treated with MDI: = 2 injections daily

4. HbA1c: 7.5% to 10%

5. Willing to measure 7 daily blood tests at least one day each week

6. Willing to sign informed consent

Exclusion Criteria:

1. Type 1 diabetes

2. CV event within the last 6 months

3. Steroid therapy > 7 days in last 6 months

4. Retinopathy - grade 3

5. Creatinine >2 mg%

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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

Locations

Country	Name	City	State
Israel	E. Wolfson Medical Center	Holon
Israel	Wolfson Medical Center, Bariatric Surgery Clinic	Holon

Sponsors (1)

Lead Sponsor	Collaborator
Wolfson Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of diabetes treatment satisfaction measured by the 'Diabetes Treatment Satisfaction Questionnaire' (DTSQ)		10 weeks
Secondary	Improvement of quality of life.	This outcome will be measured by a validated diabetes - specific quality of life questionnaire (DQOL).	10 weeks
Secondary	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
Secondary	Improvement of HbA1c	This outcome will be measured in capillary blood sample.	10 weeks
Secondary	Percent to reach target HbA1c as defined personally by the physician	This outcome will be assessed using the result of the HbA1c.	10 weeks
Secondary	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
Secondary	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