iLet Dosing Decision Software Postmarket Surveillance Plan (PS240001): The iLet Experience Study
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.
• 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