Control-IQ Observational (CLIO) Post-Approval Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,157
- 试验地点
- 1
- 主要终点
- Incidence Rates of Severe Hypoglycemia (SH)
研究概览
简要总结
Post-approval 522 study designed to collect primarily safety data on the US FDA-cleared product, t:slim X2 insulin pump with Control-IQ technology (Control-IQ system).
详细描述
Post-approval study designed to collect primarily safety data on the US FDA-cleared product, t:slim X2 insulin pump with Control-IQ technology (Control-IQ system), by assessing the rate of severe hypoglycemia (SH) and diabetic ketoacidosis (DKA) during the first 12 months of use. Secondary endpoints assessing the effectiveness of this product in real-world use by assessing the impact on patients' glycemic outcomes and user experience will also be collected. The Control-IQ system will be used as intended and in accordance with FDA-approved labeling.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with self-reported type 1 diabetes who have been prescribed the Control-IQ system.
- •At least 6 years of age
- •Using Humalog or Novolog insulin
- •For females, not pregnant or planning pregnancy in the next 12 months.
- •Agreement to use the t:slim X2 with Control-IQ technology, and to continue use for at least 12 consecutive months after study enrollment.
- •Agree to provide HbA1c result, obtained within the 6-month period prior to enrollment.
- •Ability to respond to alerts and alarms, and to provide basic diabetes self-management.
- •Patients who reside full-time in the United States.
- •Willingness to download the t:connect Mobile application to their Smartphone and keep it active throughout the study. Patients unable to use t:connect Mobile application must be willing to manually upload their insulin pump data to t:connect every three months and at the completion of the study.
- •Subject has read, understood and agreed to participate in the study, and has electronically signed the Informed Consent Form (ICF).
排除标准
- •Self-reported type 2 diabetes
- •< 6 years of age
- •Use of any glucose-lowering therapy other than Humalog or Novolog insulin
- •Inability to respond to alerts and alarms, or to provide basic diabetes self-management.
- •Pregnancy
- •Subjects who have not signed the ICF.
结局指标
主要结局
Incidence Rates of Severe Hypoglycemia (SH)
时间窗: 12 months
Overall incidence rate of events per 100 patient years
Percent of Boluses Using the Auto Population Feature Resulting in Fewer Readings Less Than 70 mg/dL Than Those Not Using the Feature
时间窗: 12 months
Percent of boluses using the auto population feature resulting in at least one reading less than 70 mg/dL than those not using the feature, in every pre-bolus glucose range examined.
Incidence Rates of Diabetic Ketoacidosis (DKA)
时间窗: 12 months
Overall incidence rate of events per 100 patient years
次要结局
- Percent Time Greater Than 180 mg/dL(12 months)
- Percent Time Less Than 54 mg/dL(12 months)
- Diabetes Impact and Satisfaction Scale (DIDS), Satisfaction Score(12 months)
- Diabetes Impact and Satisfaction Scale (DIDS), Impact Score(12 months)
- Percent Time in Range 70 - 180 mg/dL(12 months)
- Percent Time Greater Than 250 mg/dL(12 months)
- Percent Time Less Than 70 mg/dL(12 months)