Are Portable Lactate Monitoring Devices Accurate in Patients With Glycogen Storage Disease Ia When Compared to Blood Serum Lactates?
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Home lactate meter accuracy in GSDIa compared with lab lactate
研究概览
简要总结
The goal of this observational study is to determine if home lactate meters (both capillary and serum sample) are accurate, compared to lab serum lactate in a population of patients with glycogen storage disease type 1a and to determine if the Accu Chek Guide glucometer (capillary sample) is accurate, in a population of patients with glycogen storage disease type 1a.
详细描述
The goal of this observational study is to determine if home lactate meters (both capillary and serum sample) are accurate, within 20% of lab serum lactate reading 95% of the time, in a population of patients with glycogen storage disease type 1a and to determine if the Accu Chek Guide glucometer (capillary sample) is accurate, within 20% of lab serum glucose reading 95% of the time, in a population of patients with glycogen storage disease type 1a.
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
- 0 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with diagnosed/confirmed (by liver biopsy or genetic testing) Glycogen Storage Disease Type Ia (ICD 10 code: E74.01).
- •Connecticut Children's Emergency Department visit and/or admission to Connecticut Children's during time study is active
- •For pediatric participants: Ability of child's parent/legal guardian to understand and the willingness to sign a written informed consent document
- •For adults: Ability to understand and the willingness to sign a written informed consent
排除标准
- •Patients with Glycogen storage disease unspecified 74.00, or Ib
- •Patients not meeting inclusion criteria
结局指标
主要结局
Home lactate meter accuracy in GSDIa compared with lab lactate
时间窗: Every 1-3 hours for a maximum 33 hours
Lactate level via point of care finger-stick and lab draw
次要结局
- Glucometer accuracy in GSDIa compared with lab lactate(Every 1-3 hours for a maximum 33 hours)
研究者
Rebecca Riba-Wolman
Principal Investigator
Connecticut Children's Medical Center