Studies the iLet dosing software in people with type 1 diabetes
Follows people with type 1 diabetes using the iLet dosing software over one year.
Plain-language title generated from the registry record
Registry title: The iLet Experience Study
Key facts
- Where
- Irvine, United StatesSee the site
Where in United States
- Beta BionicsIrvine, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Beta Bionics, Inc.
- Trial code
- NCT06891898
- Record updated
- 8 September 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: 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.