The iLet Experience Study for Type 1 Diabetes

This study is looking at how well the iLet Dosing Decision Software works in real life for people with type 1 diabetes. You can join if you are at least 6 years old, have type 1 diabetes, and are using or planning to use the iLet Bionic Pancreas System with specific insulins like U100 Novolog, U100 Humalog, or U100 Fiasp® PumpCart®. The main goal is to see if the iLet system helps prevent severe hypoglycemia (very low blood sugar) and cognitive impairment (problems with thinking) over one year. The study will also compare outcomes to other studies and look at any device issues. The current status of this study is unclear.

Study design
This is an observational study following 1875 participants over one year to see how the iLet Dosing Decision Software performs in real-world use.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 months, with severe hypoglycemia/cognitive impairment measured at 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06891898

The iLet Experience Study

Recruiting
Not specifiedAges 6+Observational
Beta Bionics, Inc.
~1,875 participants
Updated 2025-03-24 on ClinicalTrials.gov
What's tested:iLet Dosing Decision Software

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Severe Hypoglycemia/cognitive impairment
Measured over 1 year
Type 1 Diabetes
1 sites across 1 states
California1
  • Steven J Russell, MD, PhD · PRINCIPAL_INVESTIGATOR · Beta Bionics

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Users must meet the following criteria in order to be enrolled in the study:

Exclusion

Users with the following characteristics will not be considered candidates for the study:
  • Severe Hypoglycemia/cognitive impairment1 year

    Number of severe hypoglycemia events associated with cognitive impairment requiring the assistance of a third party for treatment per 100 patient years