NCT05204134已完成不适用
Adaptation of Insulin Delivery Settings to Improve Clinical Outcomes With AID Use
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Severe Hypoglycemic Events
研究概览
简要总结
Obtain preliminary safety and performance data on a settings initialization and adaptation algorithm used in conjunction with closed-loop control.
详细描述
This feasibility study is a prospective, single arm, single center study with a run-in phase, followed by 13 weeks of Control-IQ technology use. By using an algorithm to more accurately initialize insulin delivery settings and adapt them over time, faster than typical HCP visits, users onboarding from multiple daily injections (MDI) will reach optimal glycemic outcomes faster.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult subjects ≥ age 18 years
- •Clinical diagnosis of type 1 diabetes for at least one year
- •Using a basal/bolus regimen by injection (MDI therapy)
- •Total daily dose ≥10 units/day
- •Willing to use only aspart (novolog) or lispro (humalog) U-100 insulin with the study pump.
- •A1c ≥ 7.5% and ≤ 11% at screening
- •Not pregnant or planning a pregnancy during the time period of the study.
- •Has current glucagon product to treat severe hypoglycemia (injectable or nasal) at home (will provide prescription if they do not have one)
- •Willingness to follow study procedures and a signed informed consent form
排除标准
- •Two or more episodes of severe hypoglycemia (needing assistance) in the past 6 months
- •Two or more episodes of diabetic ketoacidosis in the past 6 months
- •Inpatient psychiatric treatment in the past 6 months
- •History of drug abuse (defined as any illicit drug use) or history of alcohol abuse prior to screening or unwillingness to agree to abstain from illicit drugs throughout the study
- •Significant chronic kidney disease or hemodialysis
- •Significant liver disease
- •History of adrenal insufficiency
- •Hypothyroidism or hyperthyroidism that is not appropriately treated
- •Other chronic disease/condition determined by investigator to interfere with participation in the study
- •Use of glucocorticoids, beta blockers or other medications determined by investigator to interfere with study
- •Use of long-acting insulin, inhaled insulin (Afrezza), or use of any non-insulin glucose lowering agents (i.e. SGLT-2 inhibitor) other than Metformin with the study pump
- •Subject is pregnant or lactating or intending to become pregnant before or during participation in this study
- •Investigator judgement that subject would not be able to complete the trial
研究组 & 干预措施
Control-IQ Technology with Algorithm Derived Initial Profile Settings and Regular Updates
Experimental
After CGM run-in, participants will begin use of Control-IQ technology with algorithm derived initial insulin delivery settings, then have regular settings updates from the algorithm through 13 weeks of use.
干预措施: Automated Insulin Delivery Settings Initialization and Adaptation Algorithm (Device)
结局指标
主要结局
Severe Hypoglycemic Events
时间窗: 15 weeks
Number of Severe Hypoglycemic Events (with altered mental status)
Diabetic Ketoacidosis Events
时间窗: 15 weeks
Number of Diabetic Ketoacidosis events as defined by the Diabetes Control and Complications Trial (DCCT)
次要结局
- Percent of Time 70-140 mg/dL, Daytime Outcomes(15 weeks)
- Percent Time < 54 mg/dL, Overnight Outcomes(15 weeks)
- Percent of Time 70-180 mg/dL, Overnight Outcomes(15 weeks)
- Percent Time > 180 mg/dL, Overall(15 weeks)
- Percent Time < 54 mg/dL, Overall(15 weeks)
- Percent Time < 54 mg/dL, Daytime Outcomes(15 weeks)
- Percent Time < 70 mg/dL, Overnight Outcomes(15 weeks)
- Percent Time < 70 mg/dL, Overall(15 weeks)
- Percent Time < 70 mg/dL, Daytime Outcomes(15 weeks)
- Percent of Time 70-180 mg/dL, Daytime Outcomes(15 weeks)
- Percent Time > 180 mg/dL, Daytime Outcomes(15 weeks)
- Device Satisfaction Score, as Reported on the the Diabetes Impact and Satisfaction (DIDS) Scale at Study Completion(13 weeks)
- Percent of Time 70-140 mg/dL, Overall(15 weeks)
- Percent Time > 180 mg/dL, Overnight Outcomes(15 weeks)
- Percent Time > 250 mg/dL, Overall(15 weeks)
- Percent Time > 250 mg/dL, Overnight Outcomes(15 weeks)
- Total Daily Insulin Use(15 weeks)
- Total Daily Bolus Insulin Use(15 weeks)
- Percent of Time 70-140 mg/dL, Overnight Outcomes(15 weeks)
- Percent of Time 70-180 mg/dL, Overall(15 weeks)
- Percent Time > 250 mg/dL, Daytime Outcomes(15 weeks)
- Physician Overrides/Physician Initiated Changes in Pump Settings(13 weeks)
- Median Sensor Glucose(15 weeks)
- Total Daily Basal Insulin Use(15 weeks)
- Device Impact Score, as Reported on the Diabetes Impact and Satisfaction (DIDS) Scale at Study Completion(13 weeks)
研究者
研究点 (1)
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