Safety and Feasibility Study of a Hybrid Closed-loop Insulin Delivery System for Children and Young Adults With High Risk Acute Lymphoblastic Leukemia
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Rate of infection at the CGM insertion site
研究概览
简要总结
The overall objective of this pilot study is to determine the safety and feasibility of a hybrid closed-loop insulin delivery system for children and young adults with high risk acute lymphoblastic leukemia, during the induction chemotherapy phase while they are exposed to steroids and asparaginase that cause hyperglycemia.
详细描述
The overall objective of this pilot study is to determine the safety and feasibility of a hybrid closed-loop insulin delivery system for children and young adults with high risk acute lymphoblastic leukemia, during the induction chemotherapy phase while they are exposed to steroids and asparaginase that cause hyperglycemia. Insulin therapy would be beneficial in reducing hyperglycemia-associated complications in this period and thereby could improve other outcomes. The primary objective of the current pilot proposal is to demonstrate that hybrid closed loop pump therapy is a safe to be used in children and young adults with high risk acute lymphoblastic leukemia. If successful, the results of this study will be used to plan and support a larger, multi-center clinical trial and a grant proposal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 26 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ages 10 years old and above
- •Patients who are newly diagnosed with high-risk acute lymphoblastic leukemia
- •Patients who have started or will start an induction chemotherapy regimen containing steroid and asparaginase
- •Patients (if over 18 years of age) or parent/guardian (if the patient is under 18 years of age) must be fluent in reading and speaking English
- •Parent or guardian living in the home with the participant who also receives training on diabetes, CGM, HCL therapy, and the safety protocols
排除标准
- •Preexisting diabetes
- •Severe psychiatric disease or developmental delays, that might interfere with ability to provide informed consent
- •Active skin condition that would affect sensor placement
- •Any other medical condition which in the opinion of the investigators impairs the person's ability to safely participate in the trial, including but limited to:
- •Significant chronic kidney disease (eGFR <60) or requiring hemodialysis
- •Significant liver disease
- •History of adrenal insufficiency
- •History of abnormal TSH consistent with hypothyroidism or hyperthyroidism that is not appropriately treated
- •History of thyroid cancer
- •Use of intravenous or oral acetaminophen more than 60 mg/kg/day (maximum 4000 mg/day)
结局指标
主要结局
Rate of infection at the CGM insertion site
时间窗: 35 days
Rate of infection at the CGM insertion site, measured in occurrences per patient-day.
Rate of bleeding at the CGM insertion site
时间窗: 35 days
Rate of bleeding at the CGM insertion site, measured in occurrence per patient-day.
CGM Time in hypoglycemia (blood glucose < 70 mg/dL)
时间窗: 35 days
The primary outcome measures for this study will be the safety of HCL insulin delivery by hypoglycemia exposure. One of the primary endpoints is CGM Time in hypoglycemia (defined as blood glucose \< 70 mg/dL).
Number of episodes of symptomatic hypoglycemia
时间窗: 35 days
The primary outcome measures for this study will be the safety of HCL insulin delivery by hypoglycemia exposure. One of the primary endpoints is the number of episodes of symptomatic hypoglycemia. At each study visit, subjects will be asked about symptoms, such as shakiness, dizziness, blurred/impaired vision, sweating, pallor, clumsiness, difficulty paying attention, tingling around the lips, tongue or cheeks, change in mental status, or seizure.
Rate of infection at the HCL insulin infusion site
时间窗: 35 days
Rate of infection at the HCL insulin infusion site, measured in occurrence per patient-day.
Rate of bleeding at the HCL insulin infusion site
时间窗: 35 days
Rate of bleeding at the HCL insulin infusion site, measured in occurrence per patient-day.
次要结局
- Need for readmission during the induction phase in percent(35 days)
- Length of PICU admission in days per patient(35 days)
- Rate of remission at the end of induction in percent(35 days)
- Efficacy of glycemic control with HCL insulin delivery assessed by mean sensor glucose level(35 days)
- Length of hospitalization in days per patient(35 days)
- Efficacy of glycemic control with HCL insulin delivery assessed by Time in Ranges (TIR)(35 days)
- Rate of infection in episodes per patient-days(35 days)