FreeStyle Libre- Effect on QOL in Type 2 Diabetes Patients

November 15, 2017 updated by: zohar landau, Wolfson Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Holon, Israel, 58100
        • E. Wolfson Medical Center
      • Holon, Israel, 58100
        • Wolfson Medical Center, Bariatric Surgery Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
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
Other: SMBG
Self monitoring blood glucose: patients in this arm will measure blood glucose with personal glucometer
Device: personal glucometer
Subjects in the Control Group will measure blood glucose levels by personal glucometer (SMBG = self monitoring blood glucose)
Other Names:
  • SMBG

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of quality of life.
Time Frame: 10 weeks
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
Time Frame: 10 weeks
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
Time Frame: 10 weeks
This outcome will be measured in capillary blood sample.
10 weeks
Percent to reach target HbA1c as defined personally by the physician
Time Frame: 10 weeks
This outcome will be assessed using the result of the HbA1c.
10 weeks
Reduction in hypoglycemic events <54 mg%
Time Frame: 10 weeks
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%
Time Frame: 10 weeks
By comparing events of glucose levels below 70 mg% in the intervention group versus the control group.
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wolfson Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Actual)

July 31, 2017

Study Completion (Actual)

October 31, 2017

Study Registration Dates

First Submitted

June 8, 2016

First Submitted That Met QC Criteria

June 21, 2016

First Posted (Estimate)

June 22, 2016

Study Record Updates

Last Update Posted (Actual)

November 17, 2017

Last Update Submitted That Met QC Criteria

November 15, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0096-16-WOMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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