| NCT ID | NCT06891898 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beta Bionics, Inc. |
| Condition | Type 1 Diabetes |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,875 participants |
| Start Date | 2024-05-01 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,875 participants in total. It began in 2024-05-01 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 diabetes (T1D) with 12 months follow-up.
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
Contact & Investigator
Steven J Russell, MD, PhD
PRINCIPAL INVESTIGATOR
Beta Bionics
Frequently Asked Questions
Who can join the NCT06891898 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, studying Type 1 Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06891898 currently recruiting?
Yes, NCT06891898 is actively recruiting participants. Contact the research team at cballiro@betabionics.com for enrollment information.
Where is the NCT06891898 trial being conducted?
This trial is being conducted at Irvine, United States.
Who is sponsoring the NCT06891898 clinical trial?
NCT06891898 is sponsored by Beta Bionics, Inc.. The principal investigator is Steven J Russell, MD, PhD at Beta Bionics. The trial plans to enroll 1,875 participants.
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