FreeStyle Libre- Effect on QOL in Type 2 Diabetes Patients
NCT ID: NCT02809365
Last Updated: 2017-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2016-09-30
2017-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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.
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
personal glucometer
Subjects in the Control Group will measure blood glucose levels by personal glucometer (SMBG = self monitoring blood glucose)
Interventions
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FreeStyle Libre
Addition of FreeStyle Libre system for 10 weeks to the treatment of uncontrolled Type 2 diabetic patients currently on multiple daily injections
personal glucometer
Subjects in the Control Group will measure blood glucose levels by personal glucometer (SMBG = self monitoring blood glucose)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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%
30 Years
80 Years
ALL
No
Sponsors
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Wolfson Medical Center
OTHER_GOV
Responsible Party
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zohar landau
Head of Pediatric Endocrinology Unit
Locations
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E. Wolfson Medical Center
Holon, , Israel
Wolfson Medical Center, Bariatric Surgery Clinic
Holon, , Israel
Countries
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References
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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.
Other Identifiers
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0096-16-WOMC
Identifier Type: -
Identifier Source: org_study_id