The ILet Experience Study

Last updated: March 18, 2025
Sponsor: Beta Bionics, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes Mellitus, Type 1

Diabetes Mellitus Types I And Ii

Diabetes And Hypertension

Treatment

iLet Dosing Decision Software

Clinical Study ID

NCT06891898
PS240001
  • Ages > 6
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

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

  1. Diagnosed with type 1 diabetes and prescribed the iLet Bionic Pancreas System

  2. At least 6 years of age

  3. Using or planning to use either U100 Novolog (insulin aspart) or U100 Humalog (insulin lispro) in ready-to-fill cartridges, or U100 Fiasp® PumpCart® (insulinaspart) in pre-filled 1.6mL cartridges

  4. Willing to provide HbA1c results obtained within the 6-month period prior tostarting use of the iLet and during the last 6-months of study participation

  5. Willing to provide CGM data, if available, obtained in the 1-month period priorto starting use of the iLet

  6. For females, not pregnant or planning pregnancy in the next 12 months

  7. Able to respond to alerts and alarms, and to provide basic diabetesself-management

  8. Reside full-time in the US

  9. Able to speak and read English

  10. Willing and able to download the iLet Mobile App and keep it active throughoutthe study and upload device data regularly

  11. Willing to answer baseline survey, monthly surveys, and share CGM data, andfollow-up data, as necessary

Exclusion

Exclusion Criteria:

  • Users with the following characteristics will not be considered candidates for thestudy:

  1. Type 2 diabetes, cystic fibrosis-related diabetes, congenital hyperinsulinism,pancreatogenic diabetes, or any form of diabetes mellitus other than type 1diabetes

  2. Use or planned use of any insulin in the iLet other than U100 Novolog (insulinaspart) or U100 Humalog (insulin lispro) in ready-to-fill cartridges, or U100Fiasp® PumpCart® (insulin aspart) in pre-filled 1.6mL cartridges

  3. End-stage renal disease on renal replacement therapy (peritoneal dialysis orhemodialysis)

  4. Use or planned use of hydroxyurea

Study Design

Total Participants: 1875
Treatment Group(s): 1
Primary Treatment: iLet Dosing Decision Software
Phase:
Study Start date:
May 01, 2024
Estimated Completion Date:
June 30, 2027

Study 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.

Connect with a study center

  • Beta Bionics

    Irvine, California 92618
    United States

    Active - Recruiting

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