Observing the iLet Bionic Pancreas in real-world use for type 1 diabetes
iLet Dosing Decision Software Postmarket Surveillance Plan (PS240001): The iLet Experience Study
This study looks at how well the iLet Bionic Pancreas works and its safety for people aged 6 and older with type 1 diabetes when used in everyday life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1875 (estimated) |
| Ages | 6 Years and up |
| Sex | All |
| Sponsor | Beta Bionics, Inc. Industry-sponsored |
| Locations | 1 site (Irvine, California) |
| Trial ID | NCT06891898 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect safety and effectiveness data on the iLet Dosing Decision Software over a one-year period in individuals aged 6 and older with type 1 diabetes. Participants will use the iLet system, and their outcomes will be compared to existing data from epidemiological studies and previous trials. The study will focus on serious adverse effects, glycemic outcomes, and any device-related issues encountered during real-world use. Data will be collected through participant reports and medical records, emphasizing a comprehensive understanding of the iLet's performance.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 6 years and older diagnosed with type 1 diabetes who are prescribed the iLet Bionic Pancreas System.
Not a fit: Patients who are not using the iLet Bionic Pancreas System or those with other types of diabetes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance diabetes management and improve safety for patients using the iLet Bionic Pancreas.
How similar studies have performed: Previous studies on similar bionic pancreas systems have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Irvine, California
- Beta Bionics — Irvine, California, United States (Recruiting)
Study contacts
- Principal investigator: Steven J Russell, MD, PhD — Beta Bionics
- Study coordinator: Courtney Balliro, BS RN
- Email: cballiro@betabionics.com
- Phone: 978-500-2456
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.