The ILet Experience Study

Launched by BETA BIONICS, INC. · Mar 18, 2025

Keywords

ClinConnect Summary

The ILet Experience Study is a clinical trial that is looking at the safety and effectiveness of a new device called the iLet Dosing Decision Software for people with type 1 diabetes (T1D). This study is open to individuals aged 6 years and older who have been diagnosed with T1D and are using or planning to use specific types of insulin. Participants will need to share some health information, including blood sugar levels and data from continuous glucose monitors (CGMs), over the course of the study, which lasts for one year.

To be eligible for this study, participants must live in the U.S., be able to read and speak English, and be willing to use the iLet Mobile App to track their insulin needs. They should not be pregnant or planning to become pregnant within the next year. Throughout the study, participants will complete surveys and provide regular updates on their diabetes management. This trial is a great opportunity for eligible individuals to help researchers learn more about how the iLet system works in real life.

Gender

ALL

Eligibility criteria

• Inclusion 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
• Exclusion Criteria:
• * 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