FreeStyle Libre- Effect on QOL in Type 2 Diabetes Patients

Wolfson Medical Center (WMC)

Status: Completed

Conditions: Type 2 Diabetes

Treatments: Device: personal glucometer; Device: FreeStyle Libre

Study type: Interventional

Funder types: Other

Identifiers

NCT02809365

0096-16-WOMC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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%

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Libre

Other group

Description:

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.

Treatment:

Device: FreeStyle Libre

SMBG

Other group

Description:

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

Treatment:

Device: personal glucometer