- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02809365
FreeStyle Libre- Effect on QOL in Type 2 Diabetes Patients
The Impact on Quality of Life of Novel Glucose -Sensing Technology Used by Individuals With Type 2 Diabetes on Intensive-insulin Therapy
Study Overview
Status
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Holon, Israel, 58100
- E. Wolfson Medical Center
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Holon, Israel, 58100
- Wolfson Medical Center, Bariatric Surgery Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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%
Study Plan
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.
|
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
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Subjects in the Control Group will measure blood glucose levels by personal glucometer (SMBG = self monitoring blood glucose)
Other Names:
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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
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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).
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10 weeks
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Assessment of satisfaction from the FreeStyle Libre system
Time Frame: 10 weeks
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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.
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10 weeks
|
Reduction in hypoglycemic events <54 mg%
Time Frame: 10 weeks
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By comparing events of glucose levels below 54 mg% in the intervention group versus the control group.
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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.
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10 weeks
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
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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Clinical Trials on FreeStyle Libre
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