Actively Recruiting
The iLet Experience Study
Led by Beta Bionics, Inc. · Updated on 2025-03-24
1875
Participants Needed
1
Research Sites
160 weeks
Total Duration
On this page
Sponsors
B
Beta Bionics, Inc.
Lead Sponsor
T
The Scripps Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The iLet Experience Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with type 1 diabetes and prescribed the iLet Bionic Pancreas System
- At least 6 years of age
- Using or planning to use U100 Novolog (insulin aspart), 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 from within 6 months before starting the iLet and during the last 6 months of study participation
- Willing to provide CGM data if available from the 1 month before starting the iLet
- For females, not pregnant or planning pregnancy in the next 12 months
- Able to respond to alerts and alarms and perform 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, keep it active throughout the study, and upload device data regularly
- Willing to answer baseline and monthly surveys and share CGM and follow-up data as needed
You will not qualify if you...
- Diagnosis of type 2 diabetes, cystic fibrosis-related diabetes, congenital hyperinsulinism, pancreatogenic diabetes, or any diabetes other than type 1
- Use or planned use of any insulin with the iLet other than U100 Novolog, U100 Humalog, or U100 Fiasp PumpCart cartridges
- End-stage renal disease requiring peritoneal dialysis or hemodialysis
- Use or planned use of hydroxyurea
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beta Bionics
Irvine, California, United States, 92618
Actively Recruiting
Research Team
C
Courtney Balliro, BS RN
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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