NCT05793645招募中不适用
Clinical Investigation to Assess the Feasibility of a New Diabetes Management Program, the dALi System, for Pediatric Type 1 Diabetes (T1D) Subjects
Air Liquide Santé International3 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年5月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Assessment of adherence
研究概览
简要总结
The goal of this interventional study is to assess the adherence to a personalized care plan in patients (12-15 years) with Type 1 diabetes
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 12-15 years of age.
- •T1D diagnosis minimum 8 months prior to the Screening/Initiation visit (Visit 0).
- •Equipped with Continuous Glucose Monitoring (CGM) System, intermittent or real-time, either alone or associated with an insulin pump system
- •Subject and health care provider must use a Remote diabetes management platform for the upload and follow-up of CGM, pump data or HCL data (e.g.: Glooko, Diasend).
- •Parent or guardian able and willing to give informed consent for the subject's participation in the investigation.
排除标准
- •Initiation of use of HCL System during the last 2 months or during the investigation.
- •Use of Medtronic insulin pump.
- •Any disease or other medical condition, prior or concomitant medication /treatment
- •/intervention, that may affect this clinical investigation or in other ways make the subject unsuitable for participation in this investigation, according to the judgement of the Principal Investigator (PI), or authorized designee.
- •Participation in any clinical investigation or study within the previous 30 days, that may affect the safety or performance of this investigation.
- •Mental incapacity precluding understanding or cooperation.
- •Subject not able to read and communicate in Swedish without an interpreter.
结局指标
主要结局
Assessment of adherence
时间窗: 15 weeks
Percentage of patients adherent to the use of personalized care plan
次要结局
- Change of MIND Youth-Questionnaire (MY-Q) score from the baseline phase to the post- intervention phase.(15 weeks)
- Assessment of empowerment using Gothenburg Young Persons Empowerment Scale- Diabetes (GYPES)(15 weeks)
- Evaluation of the children satisfaction with regards to the intervention(15 weeks)
- Description of Adverse events(Through study completion, an average of 15 weeks)
- Evaluation of the parents satisfaction with regards to the intervention(15 weeks)
- Evolution of patient glycemic parameters from baseline to the end of intervention(15 weeks)
- Change of PedsQL Diabetes module score from the baseline phase to the post- intervention phase.(15 weeks)
- Change in the estimated HbA1c from the baseline phase and post intervention(15 weeks)
研究者
研究点 (3)
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