NCT04084171已完成不适用
Safety of the Tandem t:Slim X2 With Control-IQ Automated Insulin Delivery System in Preschoolers, Age 2-6 Years Old
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 6
- 主要终点
- Primary Outcome
研究概览
简要总结
A single-arm, multi-center, clinical study to assess the safety profile of the Tandem t:slim X2 with Control-IQ system in children with T1D aged 2-6 years old under free living condition
详细描述
This clinical trial aims to demonstrate the safety of the Closed-Loop Control (CLC), also known as Artificial Pancreas (AP) named t:slim X2 with Control-IQ Technology and assess usability in a supervised setting for the treatment of type 1 diabetes (T1D) in young children (2-6 years old).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 2 and < 6 years old at the time of consent
- •Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least 3 months and using insulin at the time of enrollment
- •Use of an insulin pump in the past 3 months
- •Use of Dexcom G6 for at least 11 out of the last 14 days
- •Parent/guardian(s) have familiarity with and use of carbohydrate ratios for meal boluses
- •Living with one or more parent/guardian knowledgeable about emergency procedures for severe hypoglycemia and able to contact emergency services and study staff
- •At least one parent/guardian is willing to stay with the child during the hotel/house portion of the study on the dates selected by the study team
- •Investigator has confidence that the parent/guardian(s) can successfully operate all study devices and is capable of adhering to the protocol
- •Willingness to switch to lispro (Humalog) or aspart (Novolog) if not already, and to use no other insulin besides lispro (Humalog) or aspart (Novolog) during the study
- •Total daily insulin dose (TDD) of at least 5 U/day
- •Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial
- •Child participant and parent/guardian(s) willingness to participate in all training sessions as directed by study staff
- •Willingness to discontinue non-Tandem t:slim insulin pumps during the entire study
- •Willingness to wear a Dexcom G6 sensor during the entire study
- •An understanding and willingness to follow the protocol and sign informed consent
排除标准
- •Hypoglycemia induced seizure or loss of consciousness in the past 3 months
- •Diabetes Ketoacidosis in the past 3 months
- •Use of diluted insulin
- •Concurrent use of any non-insulin glucose-lowering agent
- •Hemophilia or any other bleeding disorder
- •A condition, which in the opinion of the investigator or designee, would put the participant or study at risk. These conditions may include:
- •Acute illness at the time of the enrollment visit (fever of 101 or higher, vomiting, diarrhea)
- •Addison's disease
- •Diagnosed at less than 1 year of age without positive antibodies
- •Decreased renal function
- •Cystic fibrosis
- •Other chronic conditions, such as an underlying seizure disorder
- •Participation in another pharmaceutical or device trial at the time of enrollment or during the study.
- •Having a family member(s) employed by Tandem Diabetes Care, Inc. or having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (as a study investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial.
结局指标
主要结局
Primary Outcome
时间窗: Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.
Percentage of subjects with less than 6% time below 70mg/dL and less than 40% time above 180mg/dL.
次要结局
- Below 70 mg/dl.(Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.)
- Below 60 mg/dl.(Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.)
- Below 54 mg/dl.(Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.)
- Above 250mg/dl.(Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.)
- Above 300 mg/dl.(Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.)
- Between 70-140mg/dl.(Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.)
- Average of Carbohydrate Treatments (g).(The 5 day period of data collection included 48 hours of supervised hotel admission. The remaining 72 hours consisted of at-home Control IQ use under parental supervision and remote study staff monitoring.)
- Number of Hypoglycemia Below 70 mg/dL(Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.)
- Above 180 mg/dl.(Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.)
- Percent of Time Spent in Closed Loop(The 5 day period of data collection included 48 hours of supervised hotel admission. The remaining 72 hours consisted of at-home Control IQ use under parental supervision and remote study staff monitoring.)
- Below 50mg/dl.(Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.)
- Average Number of Treatments.(The 5 day period of data collection included 48 hours of supervised hotel admission. The remaining 72 hours consisted of at-home Control IQ use under parental supervision and remote study staff monitoring.)
- CGM Consensus Goal(Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.)
- Between 70-180mg/dl(Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.)
研究者
Marc Breton
Associate Professor
University of Virginia
研究点 (6)
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