Characterizing Diurnal Glucose Patterns of Individuals With Type 1 Diabetes and Eating Disorders
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Variation in Glycemic Profiles of ED-DMT1 and ED/only
研究概览
简要总结
The purpose of this study is to use data from the Continuous Glucose Monitor (CGM) to determine the degree of variation in glucose levels of individuals with an eating disorder and type 1 diabetes and only an eating disorder.
详细描述
The specific aims of the proposed research are to:
2.1 Determine the degree of variation in glycemic profiles of individuals with an Eating Disorder and Type 1 Diabetes (ED-DMT1) and an Eating Disorder only (ED/only); and
2.2 Determine the impact of nutritional intake and planned physical activity on glucose profiles of individuals with ED-DMT1 and ED/only.
These aims will be examined by characterizing:
- glucose exposure, as measured by area under the Ambulatory Glucose Profile (AGP) median curve;
- glucose variability, as measured by the AGP inter-quartile range; and
- glucose stability, as measured by change in the AGP median curve.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Admitted to the ISL unit at Melrose Institute
- •Diagnosed with an eating disorder (Anorexia Nervosa, Bulimia Nervosa or Eating Disorder Not Otherwise Specified)
- •For ED-DMT1 group: Diagnosis of an eating disorder AND diagnosis of type 1 diabetes.
- •For ED/only group: Diagnosis of an eating disorder AND no history/diagnosis of type 1 or type 2 diabetes.
- •At least 14 years of age.
- •Able to provide informed consent.
- •If the potential participant's age is at least 18 years she must be able to provide informed consent.
- •If the potential participant is less than 18 years she must have a parent or guardian able and willing to provide written informed consent on the participant's behalf. In addition, the participant must be willing to sign a consent on her own behalf.
- •Participants must be able and willing to utilize the CGM system and perform required calibrations using self-monitored blood glucose.
排除标准
- •Age < 14 years.
- •History of self-injurious behavior that the senior clinician feels precludes participation.
- •Unable to understand the study protocol.
- •Unwilling to follow the study protocol.
- •Participation in any competing research study.
- •Planned ISL admission for <4 days.
- •Pregnant.
- •Not able to communicate in English.
- •Regular use of acetaminophen or acetaminophen containing medications and not able to modify their medication to a non-acetaminophen based medication.
结局指标
主要结局
Variation in Glycemic Profiles of ED-DMT1 and ED/only
时间窗: 10 days
Determine the degree of variation in glycemic profiles of individuals with ED-DMT1 and ED/only using Continuous Glucose Monitoring (CGM). CGM will be graphically and statistically represented by an Ambulatory Glucose Profile (AGP).
次要结局
- Impact of Dietary Intake on Glucose Profiles of ED-DMT1 and ED/only(10 days)