NCT06891898

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,875

participants targeted

Target at P75+ for all trials

Timeline
13mo left

Started May 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress65%
May 2024Jun 2027

Study Start

First participant enrolled

May 1, 2024

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 24, 2025

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

March 24, 2025

Status Verified

March 1, 2025

Enrollment Period

3.1 years

First QC Date

March 18, 2025

Last Update Submit

March 18, 2025

Conditions

Type 1 Diabetes

Keywords

diabetespostmarket registryiLet Bionic PancreasBeta BionicsiLet Dosing Decision Software

Outcome Measures

Primary Outcomes (1)

  • Severe Hypoglycemia/cognitive impairment

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

    1 year

Secondary Outcomes (25)

  • Severe Hypoglycema/unconsciousness or seizure

    1 year

  • DKA

    1 year

  • Unanticipated Adverse Device Effects

    1 year

  • Mean CGM Glucose

    1 year

  • Time < 54 mg/dL

    1 year

  • +20 more secondary outcomes

Other Outcomes (5)

  • Mean number of swipes to unlock the iLet per day

    1 year

  • Mean number of total meal announcements made per day

    1 year

  • Average number of breakfast announcements made per day

    1 year

  • +2 more other outcomes

Study Arms (1)

iLet Bionic Pancreas

users of the iLet Bionic Pancreas installed with the iLet Dosing Decision Software

Device: iLet Dosing Decision Software

Interventions

iLet Dosing Decision SoftwareDEVICE

Interoperable alternate glycemic controller

Also known as: iLet Bionic Pancreas
iLet Bionic Pancreas

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants will include users of the iLet Dosing Decision Software who are at least 6 years old and have been diagnosed with Type 1 diabetes

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beta Bionics

Irvine, California, 92618, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Steven J Russell, MD, PhD

    Beta Bionics

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Courtney Balliro, BS RN

CONTACT

978-500-2456cballiro@betabionics.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR
Post-Marketing Study
Yes

Study Record Dates

First Submitted

March 18, 2025

First Posted

March 24, 2025

Study Start

May 1, 2024

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

March 24, 2025

Record last verified: 2025-03

Locations

US(1)