The Impact on Quality of Life of Novel Glucose -Sensing Technology Used by Individuals With Type 2 Diabetes on Intensive-insulin Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Improvement of diabetes treatment satisfaction measured by the 'Diabetes Treatment Satisfaction Questionnaire' (DTSQ)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Type 1 diabetes
- •CV event within the last 6 months
- •Steroid therapy > 7 days in last 6 months
- •Retinopathy - grade 3
- •Creatinine >2 mg%
结局指标
主要结局
Improvement of diabetes treatment satisfaction measured by the 'Diabetes Treatment Satisfaction Questionnaire' (DTSQ)
时间窗: 10 weeks
次要结局
- Improvement of quality of life.(10 weeks)
- Percent to reach target HbA1c as defined personally by the physician(10 weeks)
- Improvement of HbA1c(10 weeks)
- Reduction in hypoglycemic events <70 mg%(10 weeks)
- Assessment of satisfaction from the FreeStyle Libre system(10 weeks)
- Reduction in hypoglycemic events <54 mg%(10 weeks)
研究者
zohar landau
Head of Pediatric Endocrinology Unit
Wolfson Medical Center