Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

FreeStyle Libre- Effect on QOL in Type 2 Diabetes Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE June 8, 2016
First Posted Date  ICMJE June 22, 2016
Last Update Posted Date November 17, 2017
Study Start Date  ICMJE September 2016
Actual Primary Completion Date July 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2016)
Improvement of diabetes treatment satisfaction measured by the 'Diabetes Treatment Satisfaction Questionnaire' (DTSQ) [ Time Frame: 10 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 21, 2016)
  • Improvement of quality of life. [ Time Frame: 10 weeks ]
    This outcome will be measured by a validated diabetes - specific quality of life questionnaire (DQOL).
  • 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.
  • Improvement of HbA1c [ Time Frame: 10 weeks ]
    This outcome will be measured in capillary blood sample.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE FreeStyle Libre- Effect on QOL in Type 2 Diabetes Patients
Official Title  ICMJE The Impact on Quality of Life of Novel Glucose -Sensing Technology Used by Individuals With Type 2 Diabetes on Intensive-insulin Therapy
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Type 2 Diabetes
Intervention  ICMJE
  • 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
  • Device: personal glucometer
    Subjects in the Control Group will measure blood glucose levels by personal glucometer (SMBG = self monitoring blood glucose)
    Other Name: SMBG
Study Arms  ICMJE
  • 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.
    Intervention: Device: FreeStyle Libre
  • SMBG
    Self monitoring blood glucose: patients in this arm will measure blood glucose with personal glucometer
    Intervention: Device: personal glucometer
Publications * Yaron M, Roitman E, Aharon-Hananel G, Landau Z, Ganz T, Yanuv I, Rozenberg A, Karp M, Ish-Shalom M, Singer J, Wainstein J, Raz I. Effect of Flash Glucose Monitoring Technology on Glycemic Control and Treatment Satisfaction in Patients With Type 2 Diabetes. Diabetes Care. 2019 Jul;42(7):1178-1184. doi: 10.2337/dc18-0166. Epub 2019 Apr 29.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 21, 2016)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 31, 2017
Actual Primary Completion Date July 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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%
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02809365
Other Study ID Numbers  ICMJE 0096-16-WOMC
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party zohar landau, Wolfson Medical Center
Study Sponsor  ICMJE Wolfson Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Wolfson Medical Center
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP