NCT02403375已完成不适用
Insight Kids Study: Reaching HbA1c Targets in Children and Adolescents With Type 1 Diabetes
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 18
- 主要终点
- Percentage of Children and Adolescents of Ages 2 to 17 Years Reaching an HbA1c target of <7.5%
研究概览
简要总结
This study is to compare metabolic control, treatment satisfaction, and quality of life during continuous subcutaneous insulin infusion (CSII ) therapy with a new insulin pump system with multiple daily injections (MDI) therapy. Furthermore, this study will add clinical data originating from clinical investigation in a special population, i.e. children and adolescents of ages 2 - 17 years , to the existing clinical data of the ACCU-CHEK Insight insulin pump.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children and adolescents at least 24 months of age, and not more than 17 years of age at screening
- •Diagnosed with type 1 diabetes
- •Diagnosis of type 1 diabetes established > 6 months before study start if >5 years of age
- •Indication for insulin pump therapy according to local guidelines
- •Subject's most recent HbA1c is equal or above 7.0% (53.0 mmol/mol) - measured at last assessment before screening within the past 2 months prior to the Baseline Visit into the study
- •Willingness to use automated bolus advice obtained from the Accu-Chek Insight diabetes therapy system during the study
- •Willingness and ability to participate and comply with study procedures
排除标准
- •Disease or condition that in the opinion of the investigator is likely to affect compliance or the ability to complete the study
- •Not willing or able to start insulin pump therapy
- •Not willing to self-measure blood glucose at least four times daily
- •Significantly impaired awareness of hypoglycemia
- •More than one hospitalization for severe hypoglycemia during the last 12 months
- •History of recurrent ketoacidosis during intensive insulin therapy
- •Known strong plaster incompatibility and/or allergy
- •Unstable chronic disease other than diabetes (e.g. impaired hepatic function, impaired renal function, impaired cardiac function, uncontrolled vascular complications) and any other condition interfering with the study procedures, as per Investigator´s discretion.
- •If on antihypertensive, thyroid, anti-depressant or lipid-lowering medication, lack of stability on the medication for the past 2 months prior to the Baseline Visit in the study
- •Chronic use of steroids in adrenal suppressive doses, other immuno-modulatory medication or chemotherapy
- •Prescription medications other than insulin interfering with diabetes management
- •Acute illness or abnormality (e.g. impaired vision, impaired motor function, acute pain) at the time of screening interfering with study procedures, affecting compliance, or the ability to complete the study as per Investigator´s discretion
- •Either pregnant or breastfeeding
- •Drug dependency
- •Dependency on sponsor or Investigator (e.g. co-worker or family member)
结局指标
主要结局
Percentage of Children and Adolescents of Ages 2 to 17 Years Reaching an HbA1c target of <7.5%
时间窗: 26 weeks
This HbA1c target of \<7.5% proportion is statistically tested against a proportion of 25%, composed of the anticipated population proportion of 15% of children and adolescents using multiple daily insulin injections plus a safety margin of 10%.
次要结局
- Score on Insulin Pump Questionnaire(26 weeks)
- Score on Diabetes Treatment Satisfaction Questionnaire (DTSQ)(26 weeks)
- Score on Pediatric Quality of Life Inventory (PedsQL)(26 weeks)
- Change from Baseline in HbA1c(26 weeks)
- Number of Subjects, Who Report a Diabetes-Related Adverse Event (i.e., Symptomatic Hypoglycemia, Severe Hypoglycemia, Diabetic Ketoacidosis)(26 weeks)
- Change from Baseline in Blood Glucose(26 weeks)
研究者
研究点 (18)
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