Safety and Efficacy of Initializing the Control-IQ Artificial Pancreas System Using Total Daily Insulin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Percent Time in Range at Home Pre/Post Intervention at Home
研究概览
简要总结
The purpose of this proposed study is to assess the use of a new feature of the Control-IQ system, MyTDI.
详细描述
This trial aims to demonstrate the safety and feasibility of using MyTDI to determine insulin parameters on the Closed Loop Control (CLC) Artificial Pancreas (AP) system t:slim X2 with Control-IQ technology for use both at ski camp and at home in adolescent patients with type 1 diabetes.
Once deemed eligible, participants and their parent(s) will be trained on the use of the Tandem t:slim X2 insulin pump with Control-IQ technology and the study Dexcom G6 system. Participants will then use the this study equipment with their home insulin parameters at home for at home for 5 days. Participants will then come to the ski resort to participate in a 72-hour ski admission. Upon arrival, each participant will be randomized to either the using the Control-IQ system with their usual insulin parameters during the ski study and the at-home 5 days at home study or using the MyTDI insulin parameters during the ski study and the at-home 5 days at home study. Study duration for each participant will require 5 study visits over about 2 weeks.
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
- 12 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)
- •Diagnosis of type 1 diabetes is based on the investigator's judgement
- •Criteria for requiring insulin at diagnosis (both criteria must be met):
- •Daily insulin therapy for ≥ 6 months
- •Insulin pump therapy for ≥ 3 months
- •Age 12-18 years
- •Currently using no insulins other than one of the following rapid-acting insulins at the time of enrollment: insulin lispro (Humalog), insulin aspart (Novolog), or insulin glulisine (Apidra). If using glulisine, subject must be willing to switch to lispro or aspart.
- •Treatment with any non-insulin glucose-lowering agent (including GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas, and naturaceuticals) is permitted if stable on current dose for at least 1 month.
- •Willingness to wear a continuous glucose sensor and physiological monitor for the duration of the study.
- •For females, not pregnant or breastfeeding. Female subjects who are sexually active should agree to use birth control during the study.
- •Total daily insulin dose (TDD) at least 10 U/day.
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
- •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 judgement 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).
- •Pregnancy
- •Presence of a febrile illness within 24 hours of the Ski Admission
- •Medical or psychiatric conditions that in the judgement of the investigator might interfere with the completion of the protocol such as:
- •Inpatient psychiatric treatment in the past 6 months
- •Uncontrolled adrenal insufficiency
- •Alcohol abuse
结局指标
主要结局
Percent Time in Range at Home Pre/Post Intervention at Home
时间窗: 5 days post camp (home) compared to 5 days before camp (baseline)
The primary outcome for this study is the percent of time spent between 70mg/dL and 180mg/dL as computed by the number of CGM values falling in this interval divided by the total number of available CGM values. CGM gaps inferior to 3 hours will be linearly interpolated.
次要结局
- Average CGM at Camp(2 days during camp admission (Camp) compared to 5 days prior to camp (baseline))
- Percentage of CGM Values Below 60mg/dL at Camp(2 days during camp admission (Camp) compared to 5 days prior to camp (Baseline))
- Total Amount of Carbohydrates Corresponding to Hypoglycemia Treatment at Camp(2 days during camp admission (Camp))
- Change in Hypoglycemia Events at Home(5 days post camp (home) compared to 5 days before camp (baseline))
- Average CGM at Home(5 days post camp (home) compared to 5 days before camp (baseline))
- Percentage of CGM Values Below 54mg/dL at Camp(2 days during camp admission (Camp) compared to 5 days prior to camp (baseline))
- Percentage of CGM Values Between 70mg/dL and 180mg/dL at Camp(2 days during camp admission (Camp) compared to 5 days prior to camp (baseline))
- Percentage of CGM Values Below 50mg/dL at Home(5 days post camp (home) compared to 5 days before camp (baseline))
- Percentage of CGM Values Below 50mg/dL at Camp(2 days during camp admission (Camp) compared to 5 days prior to camp (Baseline))
- Percentage of CGM Values Above 180mg/dL at Home(5 days post camp (home) compared to 5 days before camp (baseline))
- Percentage of CGM Values Above 180mg/dL at Camp(2 days during camp admission (Camp) compared to 5 days prior to camp (baseline))
- Percentage of CGM Values Above 250mg/dL at Home(5 days post camp (home) compared to 5 days before camp (baseline))
- Percentage of CGM Values Above 250mg/dL at Camp(2 days during camp admission (Camp) compared to 5 days prior to camp (baseline))
- Percentage of CGM Values Above 300mg/dL at Home(5 days post camp (home) compared to 5 days before camp (baseline))
- Percentage of CGM Values Above 300mg/dL at Camp(2 days during camp admission (Camp) compared to 5 days prior to camp (baseline))
- Change in Total Daily Insulin at Home(5 days post camp (home) compared to 5 days before camp (baseline))
- Change in Total Meal Carbohydrates at Home(5 days post camp (home) compared to 5 days before camp (baseline))
- Change in Number of Hypoglycemic Events at Camp(2 days during camp admission (Camp) compared to 5 days prior to camp (Baseline))
- Percentage of CGM Values Below 60mg/dL at Home(5 days post camp (home) compared to 5 days before camp (baseline))
- Percentage of CGM Values Below 70mg/dL at Home(5 days post camp (home) compared to 5 days before camp (baseline))
- Percentage of CGM Values Below 70mg/dL at Camp(2 days during camp admission (Camp) compared to 5 days prior to camp (Baseline))
- Change in Total Daily Insulin at Camp(2 days during camp admission (Camp) compared to 5 days prior to camp (baseline))
- Change in Total Meal Carbohydrates at Camp(2 days during camp admission (Camp) compared to 5 days prior to camp (Baseline))
- Number of Hypoglycemia Treatment at Camp(2 days during camp admission (Camp))
研究者
Marc Breton
Principal Investigator
University of Virginia