NCT03369067已完成不适用
Real-Time Monitoring and Glucose Control During Winter-Sport Exercise in Youth With Type 1 Diabetes: The AP Ski Camp Continued
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 6
- 主要终点
- Percent Time Spent Between 70 and 180 mg/dL
研究概览
简要总结
An early feasibility study that will test the efficacy of the Tandem t:slim X2 with Control-IQ and Dexcom Continuous Glucose System G6 in a winter/ski camp environment.
详细描述
This proposal aims to demonstrate the superiority of the Closed-Loop Control (CLC), also known as Artificial Pancreas (AP) named Tandem t:slim X2 with Control-IQ Technology and assess usability in a supervised setting in a controlled environment compared with state-of-the-art Sensor-Augmented Pump (SAP) therapy for the treatment of type 1 diabetes (T1D) in adolescents. Phase 1 participants (13-18 years old) and Phase 2 participants (6-12 years old) will be assessed during a ~48 hour ski camp; Upon completion of the ski camp, Phase 2 participants (6-12 years old) will also be assessed during a ~78 hour home use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Criteria for documented hyperglycemia (at least 1 must be met):
- •Clinical diagnosis of type 1 diabetes (C-peptide levels and antibody determinations are not required)
- •The diagnosis of type 1 diabetes is based on the investigator's judgment
- •Criteria for requiring insulin at diagnosis (both criteria must be met):
- •Daily insulin therapy for ≥ 6 months
- •Insulin pump therapy for ≥ 3 months (note: must be willing to disable any glucose suspend, predictive suspend, or artificial pancreas functionality on insulin pump during study)
- •Virginia camp: age 13-18 years; Colorado/Stanford camps: 6-12 years
- •Avoidance of acetaminophen-containing medications (i.e. Tylenol) while wearing the continuous glucose monitor.
- •Willingness to wear a continuous glucose sensor and physiological monitor for the duration of the study
- •Not being pregnant at the start of the trial. All female subjects of childbearing potential will be screened for pregnancy.
- •If the participant is less than 13 years of age and the parents or the study team request it, at least one parent commit to stay with the study subject at the camp site
- •A parent/caregiver is available for system training and will commit to be the main responsible person for the use of the AP system at home
排除标准
- •Diabetic ketoacidosis in the past 6 months
- •Hypoglycemic seizure or loss of consciousness in the past 6 months
- •History of seizure disorder (except for hypoglycemic seizure)
- •History of any heart disease including coronary artery disease, heart failure, or arrhythmias
- •History of altitude sickness
- •Chronic pulmonary conditions that could impair oxygenation
- •Cystic fibrosis
- •Current use of oral glucocorticoids, beta-blockers or other medications, which in the judgment of the investigator would be a contraindication to participation in the study.
- •History of ongoing renal disease (other than microalbuminuria).
- •Subjects requiring intermediate or long-acting insulin (such as NPH, Detemir or Glargine).
- •Subjects requiring other anti-diabetic medications other than insulin (oral or injectable).
- •Presence of a febrile illness within 24 hours of start ski camp or acetaminophen use while wearing the CGM. The camp study subject will not participate in the trial if these conditions are met.
- •Medical or psychiatric condition that in the judgment of the investigator might interfere with the completion of the protocol such as (for parent and/or child):
- •Inpatient psychiatric treatment in the past 6 months
- •Uncontrolled adrenal insufficiency
- •Alcohol abuse
结局指标
主要结局
Percent Time Spent Between 70 and 180 mg/dL
时间窗: Skiing [9:30am-noon and 1:30pm-4pm]
This outcome looks at the percentage of time spent between 70 and 180 mg/dL during the Skiing periods, defined as 9:30am-noon and 1:30pm-4pm.
次要结局
- Percent Time Spent <50 mg/dL(Skiing [9:30am-noon and 1:30pm-4pm])
- Percent Time Spent <54 mg/dL(Skiing [9:30am-noon and 1:30pm-4pm])
- Percent Time Spent <60 mg/dL(Skiing [9:30am-noon and 1:30pm-4pm])
- Percent Time Spent <70 mg/dL(Skiing [9:30am-noon and 1:30pm-4pm])
- Percent Time Spent >180 mg/dL(Skiing [9:30am-noon and 1:30pm-4pm])
- Percent Time Spent >250 mg/dL(Skiing [9:30am-noon and 1:30pm-4pm])
- Percent Time Spent >300 mg/dL(Skiing [9:30am-noon and 1:30pm-4pm])
- Mean Glucose(Skiing [9:30am-noon and 1:30pm-4pm])
- Glucose Variability(Skiing [9:30am-noon and 1:30pm-4pm)
- Insulin(Skiing [9:30am-noon and 1:30pm-4pm])
- Carbohydrate (CHO) Treatment(Overall [48hr study admission])
- CHO Treatment(Skiing [9:30am-noon and 1:30pm-4pm])
- Percent Time Spent Between 70 and 150 mg/dL(Overnight [11pm - 7am])
研究者
Marc Breton
Principal Investigator
University of Virginia
研究点 (6)
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