Status:
RECRUITING
The iLet Experience Study
Lead Sponsor:
Beta Bionics, Inc.
Collaborating Sponsors:
The Scripps Research Institute
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
6+ years
Brief Summary
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 diabet...
Detailed Description
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 ...
Eligibility Criteria
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
Key Trial Info
Start Date :
May 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
1875 Patients enrolled
Trial Details
Trial ID
NCT06891898
Start Date
May 1 2024
End Date
June 1 2027
Last Update
March 24 2025
Active Locations (1)
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1
Beta Bionics
Irvine, California, United States, 92618