Use of CGM in Adolescents With Poorly-controlled Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Number of High Glucose Correction Doses Administered.
研究概览
简要总结
The purpose of this study is to see if children and adolescents with poorly controlled type 1 diabetes will benefit from using a continuous glucose monitor (CGM), a device that can be used to check blood sugars.
详细描述
Adolescents with type 1 diabetes, HbA1c ≥9% on insulin pumps were admitted to the clinical research center and a continuous glucose sensor was inserted. Sensor glucose (SG) values were compared to plasma glucose measured at least hourly using Yellow Springs Instrument's (YSI) glucose analyzer. SG rather than YSI was used for treatment decisions unless YSI was <70 mg/dL or specific criteria indicating SG and YSI were very discordant were met.
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
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •12 to <18 years old
- •T1D for at least one year
- •Treatment with insulin pump therapy
- •Willingness to comply with study procedures
排除标准
- •Current diabetic ketoacidosis
- •Hypoglycemia unawareness
- •Chronic use of medications that affect recognition of hypoglycemia (e.g., beta blockers)
- •Chronic use of medications that mimic symptoms of high or low blood sugars (e.g., decongestants)
- •Recent or frequent severe hypoglycemia (2 episodes in the last year; 1 episode in the last 6 months)
- •Skin rashes or conditions that may affect CGM placement and wear
结局指标
主要结局
Number of High Glucose Correction Doses Administered.
时间窗: 24 hrs
Principal study outcome was comparing insulin doses using pre- and post-meal sensor versus plasma glucose values. All insulin dose calculations over a 24-hour period were made using sensor glucose concentrations; these doses were compared to the those calculated as if plasma glucose were to be used instead for dose calculations.
次要结局
- Pre- and Post-meal (2-3 Hour) Glucose Levels(24 hours)
研究者
Larry A. Fox, MD
Physician
Nemours Children's Clinic