Post Market Registry to Collect Real-World Safety and Effectiveness Data for the Omnipod 5 System in Children and Adults With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,200
- 试验地点
- 2
- 主要终点
- Incidence rate of DKA
研究概览
简要总结
This is a decentralized observational clinical registry to collect real-world evidence related to the safety and effectiveness of the Omnipod 5 system in children and adults with Type 1 Diabetes.
详细描述
This is a decentralized observational clinical registry to collect real-world evidence related to the safety and effectiveness of the Omnipod 5 system in children and adults with Type 1 Diabetes.
A minimum of 2,200 Type 1 participants will be recruited to ensure a minimum of 1,650 participants completing 12 months of follow-up. The minimum number of completed participants is as follows:
- 150 participants aged 2-5
- 300 participants aged 6-13
- 300 participants aged 14-17
- 900 participants aged 18+
In addition to the enrollment targets above, a minimum of 1100 Omnipod-naïve users, 880 pump-naïve users, and 110 CGM-naïve users will be recruited.
Participants are expected to be followed for 12 months.
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
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Self-reported type 1 diabetes
- •Prescribed, obtained, and have been using the Omnipod 5 System for no more than two weeks or plan to start using the system within the next two weeks
- •Willing to use only the following types of U-100 insulin during the study: Humalog U-100, Novolog, or Admelog
- •Able to read and speak English or Spanish (when available) fluently and reside full time in the United States
- •Willing to collect A1C samples using a provided home kit and send the samples to the registry specific core laboratory at baseline and 3, 6, 9 and 12 months
- •Willing and able to complete registry assessments every two weeks
- •Willing and able to complete registry outcome questionnaires at baseline, 6 months and end of study (or at withdrawal)
- •Is not currently pregnant or planning to become pregnant in the next 12 months and is using a reliable form of birth control
- •Access to internet via phone, tablet and/or computer to use the registry online platform
- •Willing to provide CGM and insulin delivery data collected prior to using the Omnipod 5 System, if available (participants will not be excluded if data is not provided)
- •Willing and able to provide informed consent (or assent) and/or has a parent/guardian willing and able to provide informed consent as applicable
排除标准
- •Diagnosed with sickle cell anemia and/or hemoglobinopathy
- •Planned blood transfusions over the course of the study or has received a blood transfusion within 3 months prior to starting on Omnipod 5
- •Adults that are unable to provide informed consent
研究组 & 干预措施
Omnipod User
All new users for the Omnipod 5 System will be required to register with Insulet's Podder Central. Users already in Podder Central will be required to log into their account before logging into the Omnipod 5 Controller if transitioning to the Omnipod 5 System. As part of the onboarding process, users will be invited to participate in this registry.
干预措施: Omnipod 5 (Device)
结局指标
主要结局
Incidence rate of DKA
时间窗: From baseline to study completion, up to 12 months.
Measures frequency of DKA
Percentage of time < 54 mg/dL
时间窗: From baseline to study completion, up to 12 months
Glucose metric from study continuous glucose monitoring system
Percentage of time < 70 mg/dL
时间窗: From baseline to study completion, up to 12 months
Glucose metric from study continuous glucose monitoring system
Percentage of time > 180 mg/dL
时间窗: From baseline to study completion, up to 12 months
Glucose metric from study continuous glucose monitoring system
Glucose management indicator %
时间窗: From baseline to study completion, up to 12 months
MI tells you what your approximate A1C level is likely to be, based on the average glucose level from your CGM readings for 14 or more days.
Percentage of participants with time below range (<70mg/dL) of < 4%
时间窗: From baseline to study completion, up to 12 months
measurement of percentage of participants with time below range (\<70mg/dL) of \< 4%
Insulin Usage
时间窗: From baseline to study completion, up to 12 months
Measure of insulin requirements
Standard deviation of glucose mg/dL
时间窗: From baseline to study completion, about 12 months
measure of the range of glucose readings
Percentage of participants achieving A1C < 7%
时间窗: From baseline to study completion, up to 12 months
measurement of percentage of participants with A1c less than 7%
EQ-5D (inclusive of the Visual Analogue Scale (VAS))
时间窗: at baseline, at 6 months and at the end of registry participation, up to 12 months.
Questionaire
Insulin Delivery Systems: Perceptions, Ideas, Reflections, and Expectations (INSPIRE)
时间窗: at baseline, at 6 months and at the end of registry participation, up to 12 months
Questionaire
System Usability Scale (SUS)
时间窗: at baseline, at 6 months and at the end of registry participation, up to 12 months
Questionnaire
Incidence rate of severe hypoglycemia
时间窗: From baseline to study completion, up to 12 months.
Measures frequency of severe hypoglycemia
Percentage of time > 250 mg/dL
时间窗: From baseline to study completion, up to 12 months
Glucose metric from study continuous glucose monitoring system
Percentage of time in range 70-180 mg/dL
时间窗: From baseline to study completion, up to 12 months
Glucose metric from study continuous glucose monitoring system
Mean Glucose mg/dL
时间窗: From baseline to study completion, up to 12 months
Glucose metric from study continuous glucose monitoring system
Percentage of participants with time in range > 70%
时间窗: From baseline to study completion, up to12 months
measurement of percentage of participants with time in range \> 70%
Incidence rate of prolonged hyperglycemia (events per person months) during usage of Activity Feature
时间窗: From baseline to study completion, up to 12 months
Measuring rate of prolonged high sugar while in activity feature
Glucose Outcomes during the 4-hour post-bolus period using the SmartBolus Calculator: o Percentage of time < 54 mg/dL o Percentage of time in range 70-180 mg/dL
时间窗: From baseline to study completion, up to 12 months
Glucose metric from study CGM
A1c at 3, 6, 9 and 12 months
时间窗: Comparing the change in A1c at baseline compared to at 3, 6, 9 and 12 months
Measures device effectiveness
Body Mass Index (BMI) or BMI z-score
时间窗: at 6 months and at the end of registry participation, up to 12 months.
Changes in body mass index
Incidence rate of prolonged hyperglycemia (events per person months)
时间窗: From baseline to study completion, up to 12 months
Measuring the occurrence of prolonged hyperglycemia
Incidence rate of prolonged hyperglycemia (events per person months) during usage of a Target Glucose of 140 mg/dL or 150 mg/dL
时间窗: From baseline to study completion, up to 12 months
Measuring the occurrence of prolonged hyperglycemia while at a set target glucose of 140mg/dL or 150mg/dL
次要结局
未报告次要终点