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Recruiting NCT06891898

The iLet Experience Study

— Observational Type 1 Diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: iLet Dosing Decision Software.
Who it may be relevant to
Registry conditions: Type 1 Diabetes. Basic parameters: from 6 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Device iLet Dosing Decision Software
    Interoperable alternate glycemic controller

Primary outcome measures

  • Severe Hypoglycemia/cognitive impairment [Time frame: 1 year]
Secondary outcome measures (12)
  • Severe Hypoglycema/unconsciousness or seizure [Time frame: 1 year]
  • DKA [Time frame: 1 year]
  • Unanticipated Adverse Device Effects [Time frame: 1 year]
  • Mean CGM Glucose [Time frame: 1 year]
  • Time < 54 mg/dL [Time frame: 1 year]
  • Time < 70 mg/dL [Time frame: 1 year]
  • Time in Range [Time frame: 1 year]
  • Time > 180 mg/dL [Time frame: 1 year]
  • Time > 250 mg/dL [Time frame: 1 year]
  • Rate of CGM-determined hypoglycemic events [Time frame: 1 year]
  • Rate of CGM-determined hyperglycemic events [Time frame: 1 year]
  • Mean glucose coefficient of variation [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Beta Bionics — Irvine

Identifiers

NCT: NCT06891898 · PS240001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗