The iLet Experience Study

Part of paid clinical trials in Irvine, California.

Sponsor
Beta Bionics, Inc.
Study ID
NCT06891898
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
6 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • iLet Dosing Decision Software — DEVICE
    Interoperable alternate glycemic controller

Study Details

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.

Key Dates

Start date
May 1, 2024
Status verified
Mar 2025
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
1,875 participants (estimated)

Arms

  • Arm: iLet Bionic Pancreas
    users of the iLet Bionic Pancreas installed with the iLet Dosing Decision Software

Primary Outcome Measure

Severe Hypoglycemia/cognitive impairment [ Time Frame: 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Beta BionicsIrvineCalifornia92618
Steven J Russell, MD, PhD
[email protected]
855-745-3800
Courtney Balliro, BSN
[email protected]
Steven J Russell, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Irvine, CA

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
Beta Bionics· Irvine, CA

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