FreeStyle Libre- Effect on QOL in Type 2 Diabetes Patients

Not Applicable

Completed

• Conditions: Type 2 Diabetes
• Interventions: Device: FreeStyle Libre; Device: personal glucometer

• Registration Number: NCT02809365
• Lead Sponsor: Wolfson Medical Center

Brief 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.

Study Timeline

• Study First Submitted: 2016-06-08
• Study First Submitted QC: 2016-06-21
• Study First Posted: 2016-06-22
• Study Start: 2016-09
• Primary Completion: 2017-07-31
• Study Completion: 2017-10-31
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-15
• Last Update Posted: 2017-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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%

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Libre	FreeStyle Libre	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.
SMBG	personal glucometer	Self monitoring blood glucose: patients in this arm will measure blood glucose with personal glucometer

Primary Outcome Measures

Name	Time	Method
Improvement of diabetes treatment satisfaction measured by the 'Diabetes Treatment Satisfaction Questionnaire' (DTSQ)	10 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (2)

E. Wolfson Medical Center; 🇮🇱 Holon, Israel

Wolfson Medical Center, Bariatric Surgery Clinic; 🇮🇱 Holon, Israel