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NCT06891898Recruiting

The iLet Experience Study

iLet Dosing Decision Software Postmarket Surveillance Plan (PS240001): The iLet Experience Study

Source: ClinicalTrials.gov · Last updated 8 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
1875 (estimated)
First submitted
18 Mar 2025
Start date
1 May 2024
Primary completion date
Jun 2027
Lead sponsor
Beta Bionics, Inc.
NCT number
NCT06891898

What you commit to

  • Study type: Observational
  • Planned participants: 1875
  • From 1 May 2024 to the primary completion date, Jun 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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

Who the study is looking for

  • 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

Age in the registry: 6 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Beta Bionics
Coordinator of this site? Confirm its status		IrvineUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.