Patient-Reported Outcomes With the Accu-Chek® Solo Micropump System vs. Multiple Daily Injection Therapy vs. Mylife OmniPod® in Patients With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 181
- 试验地点
- 42
- 主要终点
- Treatment Satisfaction: Accu-Chek® Micropump System vs. MDI, Measured by the Difference in the Diabetes Technology Questionnaire (DTQ) Total Change Score
研究概览
简要总结
This interventional device study aims to compare mainly standard Multiple Daily Injection (MDI) therapy vs. Accu-Chek® Solo Micropump System and investigates participant satisfaction. In addition, a third arm is included to compare to only similar product on the market which is OmniPod. The third arm is for data collection purpose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed type 1 diabetes mellitus
- •At least 6 months experience with MDI therapy
- •Age ≥18 years and age ≤ 65
- •Able to perform carbohydrate counting
- •Clinically suitable for CSII including willingness to measure blood glucose at least 4 times per day or to use flash or real-time continuous glucose monitoring consistently
- •HbA1c between 7.5% (58 millimoles per mole (mmol/mol)) and 9.0% (75 mmol/mol) (determined within the last 2 months)
- •Ability and willingness to read and understand study materials (participant information, data protection and written consent form, all questionnaires etc.) and to comply with study procedures
- •Ability and willingness to use investigational devices independently and respond to alarms after training and run-in phase
- •Using a blood glucose (BG)-meter or real-time continuous glucose monitoring device that can be downloaded via Accu-Chek® Smart Pix or willingness to use a compatible meter that will be provided for the duration of the study
排除标准
- •Prior insulin pump use
- •Relevantly impaired hypoglycemia awareness
- •History of >1 hospitalization due to severe hypoglycemia within the previous 3 months
- •History of >1 hospitalization due diabetic ketoacidosis within the last 3 months
- •Significant manifestation of diabetes-related late complications
- •Pregnant or planning to become pregnant or breastfeeding
- •Known allergic reactions to plaster adhesive
- •Chronic use (therapy lasting for more than 3 months) of steroids in adrenal suppressive doses, immunosuppressive medication, or chemotherapy
- •Serious or unstable chronic medical or psychological condition(s)
- •Addiction to alcohol or other substance(s) of abuse as determined by the investigator
- •Psychological condition rendering the participant unable to understand the nature and the scope of the study
- •Plans for relocation or extensive travel
- •Participation in another clinical study within 4 weeks prior to the screening visit
- •Dependency on Sponsor or Investigator (e.g. co-worker or family member)
结局指标
主要结局
Treatment Satisfaction: Accu-Chek® Micropump System vs. MDI, Measured by the Difference in the Diabetes Technology Questionnaire (DTQ) Total Change Score
时间窗: 26 weeks
The two comparisons will be performed using a hierarchical procedure. First, the comparison between the Accu-Chek® Solo system vs. MDI will be performed and only if the corresponding Null hypothesis of no difference between both systems can be rejected, then the second comparison between Accu-Chek® Solo system and versus mylife™ OmniPod® will also be performed. The DTQ questionnaire consists of 30 questions with the individual Change Scores ranging from 1 to 5, where 1 represents 'Much worse' and 5 represents 'Much better'. The Total Change Score Range on this questionnaire is from 30 to 150 with higher scores representing lower impairment and improved outcomes.
Treatment Satisfaction: Accu-Chek® Micropump System vs. Mylife™ OmniPod®, Measured by the Difference in the Diabetes Technology Questionnaire (DTQ) Total Change Score
时间窗: 26 weeks
The two comparisons will be performed using a hierarchical procedure. First, the comparison between the Accu-Chek® Solo system vs. MDI will be performed and only if the corresponding Null hypothesis of no difference between both systems can be rejected, then the second comparison between Accu-Chek® Solo system and versus mylife™ OmniPod® will also be performed. The DTQ questionnaire consists of 30 questions with the individual Change Scores ranging from 1 to 5, where 1 represents 'Much worse' and 5 represents 'Much better'. The Total Change Score Range on this questionnaire is from 30 to 150 with higher scores representing lower impairment and improved outcomes.
次要结局
- Device Satisfaction and Treatment Preference(Baseline up to Week 39)
- Therapy Success Confirmed by Glycated Hemoglobin (Hb1Ac) Levels(Baseline up to Week 39)
- Therapy Success Indicated by Change in Body Mass Index (BMI)(Baseline up to Week 39)
- Diabetes-Related Emotional Distress Assessed by Problem Areas in Diabetes Scale (PAID)-5(Week 26 up to Week 39)
- Therapy Success Indicated by Change in Weight(Baseline up to Week 39)
- Change in Glycemic Index(Baseline up to Week 39)
- Number of Participants With Therapy Parameters Indicated by Commencement of Continuous Subcutaneous Insulin Infusion (CSII)(Baseline up to Week 39)
- Change in Therapy Parameters Based on Type of Insulin Used(Baseline up to Week 39)
- Socio-economic Acceptance: Amount of Insulin Left in Device at Reservoir Change/Device Discard(Baseline up to Week 39)
- Change in Therapy Parameters Indicated by Total Daily Insulin Dose (TDD)(Baseline up to Week 39)
- Change in Therapy Parameters Indicated by Total Daily Basal Insulin Dose (TBD)(Baseline up to Week 39)
- Percentage of Time Spent in Hypoglycaemic Blood Glucose (BG) Ranges(Baseline up to Week 39)
- Percentage of Time Spent in Hyperglycaemic Blood Glucose (BG) Ranges(Baseline up to Week 39)
- Change in Therapy Parameters Based on Average Number of Self Monitoring of Blood Glucose (SMBGs) Per Day(Baseline up to Week 39)
- Number of Consultations(Baseline up to Week 39)
- Number of Pods/Infusion Assemblies Falling Off Prematurely(Baseline up to Week 39)
- Average Time Spent on Infusion Assembly(Baseline up to Week 39)
- Number of Participants With Skin Reactions (Including Type and Intensity)(Baseline up to Week 39)
- Amount of Waste, Inferred by Total Material Consumption(Baseline up to Week 39)