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FreeStyle Libre- Effect on QOL in Type 2 Diabetes Patients

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ClinicalTrials.gov Identifier: NCT02809365
Recruitment Status : Completed
First Posted : June 22, 2016
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
zohar landau, 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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Device: FreeStyle Libre Device: personal glucometer Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Impact on Quality of Life of Novel Glucose -Sensing Technology Used by Individuals With Type 2 Diabetes on Intensive-insulin Therapy
Study Start Date : September 2016
Actual Primary Completion Date : July 31, 2017
Actual Study Completion Date : October 31, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

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 Name: SMBG




Primary Outcome Measures :
  1. Improvement of diabetes treatment satisfaction measured by the 'Diabetes Treatment Satisfaction Questionnaire' (DTSQ) [ Time Frame: 10 weeks ]

Secondary Outcome Measures :
  1. Improvement of quality of life. [ Time Frame: 10 weeks ]
    This outcome will be measured by a validated diabetes - specific quality of life questionnaire (DQOL).

  2. 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.

  3. Improvement of HbA1c [ Time Frame: 10 weeks ]
    This outcome will be measured in capillary blood sample.

  4. 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.

  5. 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.

  6. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02809365


Locations
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Israel
E. Wolfson Medical Center
Holon, Israel, 58100
Wolfson Medical Center, Bariatric Surgery Clinic
Holon, Israel, 58100
Sponsors and Collaborators
Wolfson Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: zohar landau, Head of Pediatric Endocrinology Unit, Wolfson Medical Center
ClinicalTrials.gov Identifier: NCT02809365    
Other Study ID Numbers: 0096-16-WOMC
First Posted: June 22, 2016    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by zohar landau, Wolfson Medical Center:
insulin treated
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases