NCT06891898

The iLet Experience Study

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,875 (estimated)
• Sponsor: Beta Bionics, Inc. · Industry
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

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.

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 of the Bionic Pancreas Pivotal Trial (BPPT), with a special emphasis on serious adverse effects such as severe hypoglycemia and DKA. An analysis will be conducted comparing glycemic outcomes during iLet use to baseline pre-iLet CGM and HbA1c data in participants who have provided this data. In addition, the study will determine the frequency and types of anticipated and unanticipated device issues experienced by users during real-world use.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DEVICE	iLet Dosing Decision Software	Interoperable alternate glycemic controller

Timeline

• Start date: 2024-05-01
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2025-03-24
• Last updated: 2025-03-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study