NCT02103595已完成不适用
Perception of Insertion Pain With Soft Cannula Infusion Sets: A Multicenter, Randomized, Cross-over Study to Evaluate Accu-Chek FlexLink Plus and Accu-Chek FlexLink Under Real Life Conditions.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 5
- 主要终点
- Perception of pain during infusion set insertion assessed by means of a visual analogue scale (VAS)
研究概览
简要总结
German Multi-centered, randomized, crossover study in diabetic patients evaluating two infusion sets under real life conditions at home. Subjects will be randomized to use one of the infusion set devices during the first period of 4 weeks, and be switched to the other infusion set for the second period of 4 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects at least 18 years of age
- •Diabetes mellitus type 1 or type 2
- •Continuous subcutaneous insulin therapy (CSII) for at least 3 months
- •Insulin pump compatible with Luer lock infusion set (Accu-Chek, Disetronic, Animas, Deltec Cozmo and Minimed 506 to 508)
- •Sufficient potential infusion sites suitable for the usage of a cannula length of 8 mm and a tubing length of 70 and 80 cm
- •Willing to measure blood glucose at least 4 times per day and 1-3 hrs after each new insertion
- •Willing and able to participate and comply with study procedures including the general recommendation of shifting infusion sets (at least every 3 days)
排除标准
- •Significantly impaired awareness of hypoglycemia
- •A history of or high risk of ketoacidosis during CSII therapy
- •Frequent catheter abscesses in the past year, as per investigator´s discretion
- •Known strong plaster incompatibility and/or allergy (history of catheter use)
- •Unstable chronic disease other than diabetes
- •Chronic use of steroids in adrenal suppressive doses, other immuno-modulatory medication or chemotherapy
- •Acute illness or abnormality at the time of screening rendering the patient not suitable to participate in the study in the opinion of the Investigator
- •Chronic use of analgesics and any other condition interfering with the assessment of pain, as per investigator´s discretion
- •Are either pregnant or breastfeeding or are currently planning a pregnancy
结局指标
主要结局
Perception of pain during infusion set insertion assessed by means of a visual analogue scale (VAS)
时间窗: 8 weeks
次要结局
- Incidence of adverse events(8 weeks)
- Insulin set replacement pattern(8 weeks)
- Incidence of kinked cannulas(8 weeks)
- Pump settings, including insulin dosage(8 weeks)
- Device satisfaction/preference as assessed by patient surveys(8 weeks)
- Investigator assessment of patient device use(At Baseline and Week 4)
研究者
研究点 (5)
Loading locations...
相似试验
已完成
不适用
Intrauterine Device Insertion and Felt PainIntrauterine Device MigrationNCT05956184Ankara City Hospital Bilkent128
已完成
不适用
Local Anesthesia With Needle-free Injection SystemPediatric AnesthesiaLocal AnesthesiaNCT04028271Sinem yildirim60
已完成
1 期
A Study of the Use of Microneedle Patches to Deliver Topical Lidocaine in the Oral CavityTopical AnaesthesiaNCT03629041Innoture Ltd16
已完成
1 期
Study Comparing The Tolerability Of Three Excipient Formulations Administered Subcutaneously To Healthy SubjectsHealthyNCT01401764Ablynx, a Sanofi company30
招募中
不适用
Pain Perception Comparison of Computerized vs Conventional Injection MethodsPain PerceptionLocal AnesthesiaNCT06129162Mansoura University120