The ILet Experience Study

Eligibility Criteria

• * Users must meet the following criteria in order to be enrolled in the study:
• 1. Diagnosed with type 1 diabetes and prescribed the iLet Bionic Pancreas System
• 2. At least 6 years of age
• 3. 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
• 4. 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
• 5. Willing to provide CGM data, if available, obtained in the 1-month period prior to starting use of the iLet
• 6. For females, not pregnant or planning pregnancy in the next 12 months
• 7. Able to respond to alerts and alarms, and to provide basic diabetes self-management
• 8. Reside full-time in the US
• 9. Able to speak and read English
• 10. Willing and able to download the iLet Mobile App and keep it active throughout the study and upload device data regularly
• 11. Willing to answer baseline survey, monthly surveys, and share CGM data, and follow-up data, as necessary
• * Users with the following characteristics will not be considered candidates for the study:
• 1. Type 2 diabetes, cystic fibrosis-related diabetes, congenital hyperinsulinism, pancreatogenic diabetes, or any form of diabetes mellitus other than type 1 diabetes
• 2. 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
• 3. End-stage renal disease on renal replacement therapy (peritoneal dialysis or hemodialysis)
• 4. Use or planned use of hydroxyurea