Treatment Satisfaction of Using OmniPod System Compared With Conventional Insulin Pump in Adults With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Treatment satisfaction
研究概览
简要总结
Randomized, two arms, open study in order to evaluate treatment satisfaction of using OmniPod system compared with conventional insulin pump in adults with type 1 diabetes.
The study will include two consecutive 12 weeks treatment periods. According to randomization, each patient will be treated consecutively with both treatment arms: 12 weeks with OmniPod system and than 12 weeks with patient's previous insulin pump or vice versa.
详细描述
A Randomized, two arms, open, crossover study in order to evaluate treatment satisfaction of using OmniPod system compared with conventional insulin pump in adults with type 1 diabetes.
The study will include two consecutive 12 weeks treatment periods. According to randomization, each patient will be treated consecutively with both treatment arms: 12 weeks with OmniPod system and than 12 weeks with patient's previous insulin pump or vice versa.
Study will consist of 4 clinic visits taking place at -2,0,12 and 24 weeks and additional 4 telephone visits taking place at 4,8,16 and 20 weeks. In addition, patients will be invited one week prior to visit 5 and visit 8 in order to insert a continuous glucose sensor. Patients will complete DTSQ and Comfort & Function questionnaires at weeks 0, 12 and 24, before and at the end of each study arm.
On each clinical visits the following parameters will be evaluated: vital signs, HbA1c, 4 and 7 points glucose profile, hypoglycemia events, hyperglycemia events and pump related technical problems.
The telephone visits will include pump related technical problems solving and AE/SAE reporting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes diagnosed at least 1 year prior to study entry
- •Use of continuous subcutaneous insulin infusion therapy for at least one year
- •Age: 18-35 years old
- •HbA1c >8.0
- •At least 4 self blood glucose measurements per day
- •No more than one severe hypoglycaemic or ketoacidosis episode within the past year and none within the past month
- •Capable of reading pump screen in English
- •Able to understand and sign subject informed consent forms
排除标准
- •Any significant disease or conditions, including psychiatric disorders that in the opinion of the principal investigator are likely to effect subject compliance or the subjects ability to complete the study.
- •Patients participating in other device or drug studies
- •Clinical diagnosis of hypoglycaemic unawareness
- •Known dermal hypersensitivity to products that contain medical adhesive
- •Taking prescription medications that could complicate the management of glycemic control.
- •Inability to understand/complete the Treatment satisfaction questionnaire
研究组 & 干预措施
OmniPod system
At this arm patients will be treated with the OmniPod system for 12 weeks
干预措施: OmniPod system (Device)
patient's conventional pump
At this arm patients will be treated with their conventional pump for 12 weeks
干预措施: Patient's conventional pump (Device)
结局指标
主要结局
Treatment satisfaction
时间窗: Diabetes Treatment Satisfaction Questionnare (DTSQ) will be completed at baseline, 12 and 24 weeks
次要结局
- Comfort and function(Comfort and function questionnaires will be completed at weeks 0,12 and 24.)
- HbA1C(HbA1C will be measured at screening, baseline, 12 weeks and 24 weeks)
- Fructosamine(Fructosamine will be measured at baseline,12 and 24 weeks)
- 7 points glucose profile(diary will be completed before every clinical visit)
- Pump related technical difficulties(pump related technical difficulties will be analyzed every telephone visit)
- continuous glucose measurements(continuous glucose sensor will be inserted one week before visits 5 and 8)