Title: Closed-loop Medtronic 780G System in Youth With Type 1 Diabetes: AWeSoMe Study Group Prospective Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Time spent in range (70-180 mg/dL) as assessed from closed-loop Medtronic 780G system
研究概览
简要总结
The goal of this observational study is to describe data on Israeli children and youth using the 780G system including data regarding glycemic control parameters, various questionnaires, sleep data, bioimpedance measures, and dietary parameters. The main questions it aims to answer are: • whether the 780G system will improve glycemic control • whether the psychosocial aspects will improve. Participants will be followed once connected to 780G, at baseline, one, three, and six months after the connection.
详细描述
Patients and Methods:
The study population will include individuals with type 1 diabetes ages 7-18 years who are managed by the pediatric diabetes teams from the AWeSoMe Study Group (five pediatric diabetes multidisciplinary clinics in Israel; Dana-Dwek Children's Hospital, Edmond and Lily Safra Children's Hospital, Maccabi National Juvenile Diabetes Center, Shamir Medical Center and Wolfson Medical Center) and who chose to purchase 780G out-of-pocket as part of their diabetes care, or are eligible according to the updated Israeli basket to receive it. The decision to use 780G will be made prior to and independent of their entrance to the study, and will be based on preferences of the patients and their parents.
Study design:
A prospective multi-center study (AWeSoMe Study Group) of type 1 diabetes patients using the closed-loop Medtronic 780G system as compared to their previous treatment regimen.
Data will be collected at 4 timepoints: baseline (at initiation of 780G system), after 1 month, three months and 6 months of the closed-loop Medtronic 780G system usage.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of type 1 diabetes Diabetes duration ≥ 6 months Routine attendance at clinic visits Initiation of 780G system usage
排除标准
- •Children under the age of 1 year Children without 780G system
结局指标
主要结局
Time spent in range (70-180 mg/dL) as assessed from closed-loop Medtronic 780G system
时间窗: 0,6 months
Change in time spent in range (70-180 mg/dL) from baseline to six months of closed-loop Medtronic 780G system
次要结局
- Quality of life - child as assessed by a questionnaire(0, 6 months)
- Fear of hypoglycemia - child as assessed by a questionnaire(0, 6 months)
- Diabetes management - child as assessed by a questionnaire(0, 6 months)
- Time spent below range (≤ 70 mg/dL) as assessed from closed-loop Medtronic 780G system(0, 6 months)
- Time spent above range (> 250 mg/dL) as assessed from closed-loop Medtronic 780G system(0, 6 months)
- Quality of life - parent as assessed by a questionnaire(0, 6 months)
- Nutrition diaries as assessed by a dietician(0, 6 months)
- HbA1c as assessed from point-of-care clinic visit(0, 6 months)
- Time spent below range (≤ 54 mg/dL) as assessed from closed-loop Medtronic 780G system(0, 6 months)
- Trait anxiety - child as assessed by a questionnaire(0, 6 months)
- Time spent above range (> 180 mg/dL) as assessed from closed-loop Medtronic 780G system(0, 6 months)
- Fear of hypoglycemia - parent as assessed by a questionnaire(0, 6 months)
- Diabetes management - parent as assessed by a questionnaire(0, 6 months)
- Sleep quality as assessed by a questionnaire(0, 6 months)
研究者
Dr. Noah Gruber
Pediatric endocrinologist
Sheba Medical Center