Evaluation of Malglycemia Via Continuous Glucose Monitoring in the Pediatric Hematopoietic Stem Cell Transplant Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- The number of patients with Malgylcemia
研究概览
简要总结
This study is designed to determine feasibility of using a continuous glucose monitor in pediatric, adolescent and young adult hematopoietic stem cell transplant (HSCT) recipients, and to identify the incidence and risk factors for malglycemia in primary admission for pediatric, adolescent and young adult HSCT patients as well as to characterize the relationship between outcomes and malglycemia in this population.
详细描述
This study is a prospective observational cohort analysis examining the rate of malglycemia in the pediatric HSCT population and the effect of malglycemia on important post-HSCT outcomes. In addition to usual care during the peri-HSCT period, participants in this trial will be asked to wear a continuous glucose monitor for the duration of their initial hospital admission. Participants will wear this monitor while admitted to the hospital for up to one week prior to transplant, and up to 60 days after transplant.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients age 2 to 30 years old at time of transplant.
- •Patients undergoing hematopoietic stem cell transplantation at CHCO.
- •Subject willing to wear a continuous glucose monitor for the duration of the study.
- •Subject willing to follow study protocols.
排除标准
- •Preexisting diagnosis of type 1 diabetes, type 2 diabetes, or an insulin requirement in the 2 weeks preceding transplant.
- •Preexisting condition requiring use of steroids (other than HSCT)
- •Severe psychiatric disease or developmental delays that might interfere with ability to provide informed consent.
- •Any other medical condition which in the opinion of the investigators impairs the person's ability to safely participate in the trial.
- •Subject has an active skin condition that would affect sensor placement.
结局指标
主要结局
The number of patients with Malgylcemia
时间窗: 1 week prior to transplant through maximum 60 days post-transplant; inpatient only
Hypoglycemia (BG \< 70 mg/dL), hyperglycemia (BG ≥ 126 mg/dL), or glycemic variability (σ ≥ 29 mg/dL). Participants will wear a continous glucose monitor (CGM) to measure glycemia levels. This will service both as an exposure and and outcome.
The number patients that contract an infection
时间窗: 0-100 days post-transplant
Infection, defined by clinically significant positive microbiology or radiology result
次要结局
- The length of hospital stays for all participants(Through study completion to 1 year of follow-up)
- The Graft-versus-host-disease (GVHD) status of all participants(Through study completion to 1 year of follow-up)
- The length of hospital stays in the ICU for all participants(Through study completion to 1 year of follow-up)