Clinical trial NCT02809365: FreeStyle Libre- Effect on QOL in Type 2 Diabetes Patients
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: insulin treated
Lead sponsor: Wolfson Medical Center
Sponsor class: OTHER_GOV
First posted: 2016-06-22
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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%

Primary outcomes:
measure: Improvement of diabetes treatment satisfaction measured by the 'Diabetes Treatment Satisfaction Questionnaire' (DTSQ)
timeFrame: 10 weeks
Secondary outcomes:
measure: Improvement of quality of life.
timeFrame: 10 weeks
measure: Assessment of satisfaction from the FreeStyle Libre system
timeFrame: 10 weeks
measure: Improvement of HbA1c
timeFrame: 10 weeks
measure: Percent to reach target HbA1c as defined personally by the physician
timeFrame: 10 weeks
measure: Reduction in hypoglycemic events <54 mg%
timeFrame: 10 weeks
measure: Reduction in hypoglycemic events <70 mg%
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Holon
country: Israel
facility: E. Wolfson Medical Center
city: Holon
country: Israel
facility: Wolfson Medical Center, Bariatric Surgery Clinic
Study officials:
References:
citation: 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.