iLet Dosing Decision Software Postmarket Surveillance Plan (PS240001): The iLet Experience Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,875
- 试验地点
- 2
- 主要终点
- Severe Hypoglycemia/cognitive impairment
研究概览
简要总结
A one-year, prospective single-arm cohort study to collect safety and effectiveness data on the iLet Dosing Decision Software during real-world use in people 6 years of age or older with type 1 diabetes (T1D) with 12 months follow-up.
详细描述
The study will compare outcomes data during iLet use to efficacy and safety outcomes data derived from epidemiological studies, such as data published by the T1D Exchange registry, and to the results of the Bionic Pancreas Pivotal Trial (BPPT), with a special emphasis on serious adverse effects such as severe hypoglycemia and DKA. An analysis will be conducted comparing glycemic outcomes during iLet use to baseline pre-iLet CGM and HbA1c data in participants who have provided this data. In addition, the study will determine the frequency and types of anticipated and unanticipated device issues experienced by users during real-world use.
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
- •Users must meet the following criteria in order to be enrolled in the study:
- •Diagnosed with type 1 diabetes and prescribed the iLet Bionic Pancreas System
- •At least 6 years of age
- •Using or planning to use either U100 Novolog (insulin aspart) or U100 Humalog (insulin lispro) in ready-to-fill cartridges, or U100 Fiasp® PumpCart® (insulin aspart) in pre-filled 1.6mL cartridges
- •Willing to provide HbA1c results obtained within the 6-month period prior to starting use of the iLet and during the last 6-months of study participation
- •Willing to provide CGM data, if available, obtained in the 1-month period prior to starting use of the iLet
- •For females, not pregnant or planning pregnancy in the next 12 months
- •Able to respond to alerts and alarms, and to provide basic diabetes self-management
- •Reside full-time in the US
- •Able to speak and read English
- •Willing and able to download the iLet Mobile App and keep it active throughout the study and upload device data regularly
- •Willing to answer baseline survey, monthly surveys, and share CGM data, and follow-up data, as necessary
排除标准
- •Users with the following characteristics will not be considered candidates for the study:
- •Type 2 diabetes, cystic fibrosis-related diabetes, congenital hyperinsulinism, pancreatogenic diabetes, or any form of diabetes mellitus other than type 1 diabetes
- •Use or planned use of any insulin in the iLet other than U100 Novolog (insulin aspart) or U100 Humalog (insulin lispro) in ready-to-fill cartridges, or U100 Fiasp® PumpCart® (insulin aspart) in pre-filled 1.6mL cartridges
- •End-stage renal disease on renal replacement therapy (peritoneal dialysis or hemodialysis)
- •Use or planned use of hydroxyurea
研究组 & 干预措施
iLet Bionic Pancreas
users of the iLet Bionic Pancreas installed with the iLet Dosing Decision Software
干预措施: iLet Dosing Decision Software (Device)
结局指标
主要结局
Severe Hypoglycemia/cognitive impairment
时间窗: 1 year
Number of severe hypoglycemia events associated with cognitive impairment requiring the assistance of a third party for treatment per 100 patient years
次要结局
- Time in Range(1 year)
- Severe Hypoglycema/unconsciousness or seizure(1 year)
- DKA(1 year)
- Time < 54 mg/dL(1 year)
- Unanticipated Adverse Device Effects(1 year)
- Mean CGM Glucose(1 year)
- Time < 70 mg/dL(1 year)
- Time > 180 mg/dL(1 year)
- Time > 250 mg/dL(1 year)
- Rate of CGM-determined hypoglycemic events(1 year)
- Rate of CGM-determined hyperglycemic events(1 year)
- Mean glucose coefficient of variation(1 year)
- Time in BG-Run mode(1 year)
- Time in BG-run mode for longer than 4 hours(1 year)
- Severe Hypoglycemia During BG-run mode(1 year)
- DKA During BG-run mode(1 year)
- Unanticipated Adverse Device Effects during BG-run mode(1 year)
- Average duration of BG-run mode episodes(1 year)
- Percentage of time insulin suspended during BG-Run episodes >4 hours(1 year)
- Mean CGM glucose at time of entry into BG-run episodes >4 hours(1 year)
- Mean CGM glucose at time of exit from BG-run episodes >4 hours(1 year)
- Insulin TDD(1 year)
- Mean Baseline HbA1c of all Participants(Baseline)
- Mean HbA1c on iLet(1 year or final available during study period)
- Mean change in HbA1c(1 year or final available during study period compared to baseline)