The iLet Experience Study

September 2, 2026 updated by: Beta Bionics, Inc.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1875

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-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

Description

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® (insulin aspart) in pre-filled 1.6mL cartridges
    4. 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
    5. Willing to provide CGM data, if available, obtained in the 1-month period prior to 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 diabetes self-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 throughout the study and upload device data regularly
    11. 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:

    1. Type 2 diabetes, cystic fibrosis-related diabetes, congenital hyperinsulinism, pancreatogenic diabetes, or any form of diabetes mellitus other than type 1 diabetes
    2. 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
    3. End-stage renal disease on renal replacement therapy (peritoneal dialysis or hemodialysis)
    4. Use or planned use of hydroxyurea

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
iLet Bionic Pancreas
users of the iLet Bionic Pancreas installed with the iLet Dosing Decision Software
Device: iLet Dosing Decision Software
Interoperable alternate glycemic controller
Other Names:
  • iLet Bionic Pancreas

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Severe Hypoglycemia/cognitive impairment
Time Frame: 1 year
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Severe Hypoglycema/unconsciousness or seizure
Time Frame: 1 year
Number of severe hypoglycemia events associated with unconsciousness or seizure per 100 patient years
1 year
DKA
Time Frame: 1 year
Number of diabetic ketoacidosis events per 100 patient years
1 year
Unanticipated Adverse Device Effects
Time Frame: 1 year
Rate of unanticipated adverse device effects
1 year
Mean CGM Glucose
Time Frame: 1 year
Mean glucose as determined by CGM after 1 year of iLet use
1 year
Time < 54 mg/dL
Time Frame: 1 year
Percentage of time with CGM glucose < 54 mg/dL
1 year
Time < 70 mg/dL
Time Frame: 1 year
Percentage of time with CGM glucose < 70 mg/dL
1 year
Time in Range
Time Frame: 1 year
Percentage of time with CGM glucose 70-180 mg/dL
1 year
Time > 180 mg/dL
Time Frame: 1 year
Percentage of time with CGM glucose > 180 mg/dL
1 year
Time > 250 mg/dL
Time Frame: 1 year
Percentage of time with CGM glucose > 250 mg/dL
1 year
Rate of CGM-determined hypoglycemic events
Time Frame: 1 year
Rate of hypoglycemic events defined as at least 15 consecutive minutes of CGM glucose < 54 mg/dL - the hypoglycemic event ends when there are at least 15 consecutive minutes with a CGM glucose greater than or equal to 70 mg/dL and the participant becomes eligible for another hypoglycemic event
1 year
Rate of CGM-determined hyperglycemic events
Time Frame: 1 year
Rate of hyperglycemic events defined as at least 90 cumulative minutes with a CGM glucose value > 300 mg/dL within a 120-minute period - the hyperglycemic event ends when there are at least 15 consecutive minutes with a CGM glucose value less than or equal to 180 mg/dL and the participant becomes eligible for another hyperglycemic event.
1 year
Mean glucose coefficient of variation
Time Frame: 1 year
Mean CGM glucose Intrasubject coefficient of variation
1 year
Time in BG-Run mode
Time Frame: 1 year
Percent of time spent in BG-run mode
1 year
Time in BG-run mode for longer than 4 hours
Time Frame: 1 year
Percent of time spent in BG-run mode episodes longer than 4 hours
1 year
Severe Hypoglycemia During BG-run mode
Time Frame: 1 year
Rate of severe hypoglycemic events beginning during a BG-run mode episode that lasted more than 4 hours or within 6 hours of a BG-run episode that lasted more than 4 hours
1 year
DKA During BG-run mode
Time Frame: 1 year
Rate of diabetic ketoacidosis events during a BG-run mode episode that lasted more than 4 hours or within 6 hours of a BG-run episode that lasted more than 4 hours
1 year
Unanticipated Adverse Device Effects during BG-run mode
Time Frame: 1 year
Rate of unanticipated adverse device effects during BG-run mode
1 year
Average duration of BG-run mode episodes
Time Frame: 1 year
Average duration of BG-run mode episodes
1 year
Percentage of time insulin suspended during BG-Run episodes >4 hours
Time Frame: 1 year
During BG-run mode episodes that lasted more than 4 hours, percentage of time no insulin could be delivered as a result of failure to enter BG values at the required intervals
1 year
Mean CGM glucose at time of entry into BG-run episodes >4 hours
Time Frame: 1 year
Mean CGM glucose at the time of entry into BG-run mode episodes that lasted more than 4 hours
1 year
Mean CGM glucose at time of exit from BG-run episodes >4 hours
Time Frame: 1 year
Mean CGM glucose at the time of exit from BG-run mode into CGM-run mode after episodes of BG-run mode that lasted more than 4 hours
1 year
Insulin TDD
Time Frame: 1 year
Insulin total daily dose (u/kg/day)
1 year
Mean Baseline HbA1c of all Participants
Time Frame: Baseline
The last available baseline HbA1c value (when available) will be reported as the mean ± standard deviation.
Baseline
Mean HbA1c on iLet
Time Frame: 1 year or final available during study period
The last available HbA1c value during the study period (when available) will be reported as the mean ± standard deviation.
1 year or final available during study period
Mean change in HbA1c
Time Frame: 1 year or final available during study period compared to baseline
The change in HbA1c from the last available baseline value to the last available value during the study period (when both values are available) will be reported as the mean ± standard deviation.
1 year or final available during study period compared to baseline

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean number of swipes to unlock the iLet per day
Time Frame: 1 year
Mean number of swipes to unlock the iLet per day
1 year
Mean number of total meal announcements made per day
Time Frame: 1 year
Mean number of meal announcements made per day - total regardless of meal type
1 year
Average number of breakfast announcements made per day
Time Frame: 1 year
Mean number of total breakfast announcements made per day
1 year
Average number of lunch announcements made per day
Time Frame: 1 year
Mean number of total lunch announcements made per day
1 year
Average number of dinner announcements made per day
Time Frame: 1 year
Mean number of total dinner announcements made per day
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beta Bionics, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Scripps Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Steven J Russell, MD, PhD, Beta Bionics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 18, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 24, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PS240001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

It has not yet been decided if IPD will be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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