RecruitingNCT06891898

The iLet Experience Study

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

Sponsor

Beta Bionics, Inc.

Enrollment

1,875 participants

Start Date

May 1, 2024

Study Type

OBSERVATIONAL

Conditions

Type 1 Diabetes

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

Min Age: 6 Years

Plain Language Summary

Simplified for easier understanding

This study is collecting real-world experience data from people using the iLet Bionic Pancreas System — an automated insulin delivery device that manages blood sugar without requiring users to count carbohydrates — to understand how it performs in everyday life for people with type 1 diabetes. **You may be eligible if...** - You have been diagnosed with type 1 diabetes and have been prescribed the iLet Bionic Pancreas System - You are at least 6 years old - You are using or plan to use one of the approved insulin types in the device - You are willing to share your HbA1c and continuous glucose monitor (CGM) data - If female, you are not pregnant and not planning pregnancy in the next 12 months **You may NOT be eligible if...** - You have type 2 diabetes or another type of diabetes - You are pregnant or planning to become pregnant in the next year - You are unwilling to share your glucose monitoring data Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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