NCT03563313已完成不适用
A Pivotal Study of t:Slim X2 With Control-IQ Technology
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 168
- 试验地点
- 13
- 主要终点
- Time in Target Range
研究概览
简要总结
The objective of the study is to assess efficacy and safety of a closed loop system (t:slim X2 with Control-IQ Technology) in a large randomized controlled trial.
详细描述
After consent is signed, eligibility will be assessed. Eligible participants not currently using an insulin pump and Dexcom CGM with minimum data requirements will initiate a run-in phase of 2 to 8 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 2:1 to the use of closed-loop control (CLC group) using t:slim X2 with Control-IQ Technology vs. SAP for 6 months.
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
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year and using insulin for at least 1 year.
- •Familiarity and use of a carbohydrate ratio for meal boluses.
- •Age ≥14.0 years old.
- •For females, not currently known to be pregnant. If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative serum or urine pregnancy test will be required for all females of child-bearing potential. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued.
- •For participants <18 years old, living with one or more parent/legal guardian knowledgeable about emergency procedures for severe hypoglycemia and able to contact the participant in case of an emergency.
- •Willingness to suspend use of any personal CGM for the duration of the clinical trial once the study CGM is in use.
- •Willingness to use a regular insulin pump during the study with no automatic insulin adjustment based on glucose level when assigned to participate in an SAP group
- •Investigator has confidence that the participant 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 using already, and to use no other insulin besides lispro (Humalog) or aspart (Novolog) during the study.
- •Total daily insulin dose (TDD) at least 10 U/day.
- •Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial.
- •Exclusion Criteria
- •Concurrent use of any non-insulin glucose-lowering agent other than metformin (including GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas).
- •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.
- •Participation in another pharmaceutical or device trial at the time of enrollment or during the study.
- •Employed by, or having immediate family members employed by Tandem Diabetes Care, Inc. or TypeZero Technologies, LLC, 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.
排除标准
- 未提供
结局指标
主要结局
Time in Target Range
时间窗: 26 weeks
The primary outcome is time in target range 70-180 mg/dL measured by CGM in CLC group vs. SAP group.
次要结局
- HbA1c at 26 Weeks(26 weeks)
- Coefficient of Variability(26 weeks)
- LBGI(26 weeks)
- CGM Time >250(26 weeks)
- Number of Participants With HbA1c <7.0% at 26 Weeks(26 weeks)
- Basal:Bolus Insulin Ratio(26 weeks)
- CGM Time Below 54(26 weeks)
- CGM Time Below 60(26 weeks)
- BMI(26 weeks)
- CGM Time in Range 70-140 mg/dL(26 weeks)
- HBGI(26 weeks)
- Number of Participants With HbA1c Improvement From Baseline to 26 Weeks >0.5%(26 weeks)
- HbA1c Relative Improvement From Baseline to 26 Weeks >10%(26 weeks)
- CGM Time Above 180(26 weeks)
- CGM Mean Glucose(26 weeks)
- CGM Hypoglycemia Events(26 weeks)
- CGM Time >300(26 weeks)
- Number of Participants With HbA1c Improvement From Baseline to 26 Weeks >1.0%(26 weeks)
- HFS-II(26 weeks)
- Clarke Hypoglycemia Awareness Scores(26 weeks)
- System Usability Scores (SUS)(26 weeks)
- Technology Acceptance Questionnaire(26 weeks)
- Total Daily Insulin(26 weeks)
- CGM Time Below 70(26 weeks)
- Standard Deviation of CGM(26 weeks)
- Number of Participants With HbA1c <7.5% at 26 Weeks(26 weeks)
- Number of Participants With HbA1c Improvement From Baseline to 26 Weeks >1.0% or HbA1c <7.0% at 26 Weeks(26 weeks)
- Hyperglycemia Avoidance Scale(26 weeks)
- Hypoglycemia Confidence Scale(26 weeks)
- INSPIRE Survey Scores(26 weeks)
- Diabetes Distress Scale(26 weeks)
- Weight(26 weeks)
研究者
Sue Brown
Principal Investigator
University of Virginia
研究点 (13)
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