Type 1 DiabetesNCT06891898
The iLet Experience Study
An observational study of Type 1 Diabetes, run by Beta Bionics, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- iLet Dosing Decision Software
- Type of treatment
- Medical device
- How many people
- 1,875 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2024to Jun 2027
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Beta Bionics
Irvine, California, 92618
Steven J Russell, MD, PhD, 855-745-3800, srussell@betabionics.com
Courtney Balliro, BSN, cballiro@betabionics.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Type 1 Diabetes
- Being tested
- iLet Dosing Decision Software
- Keywords
- diabetes, postmarket registry, iLet Bionic Pancreas, Beta Bionics, iLet Dosing Decision Software
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iLet Dosing Decision SoftwareDevice
Also called iLet Bionic Pancreas
Interoperable alternate glycemic controller
| Study group | Role | What they receive |
|---|---|---|
| iLet Bionic Pancreas | users of the iLet Bionic Pancreas installed with the iLet Dosing Decision Software Receives: Device: iLet Dosing Decision Software |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (25)
Severe Hypoglycema/unconsciousness or seizure
Number of severe hypoglycemia events associated with unconsciousness or seizure per 100 patient years
Measured: 1 year
DKA
Number of diabetic ketoacidosis events per 100 patient years
Measured: 1 year
Unanticipated Adverse Device Effects
Rate of unanticipated adverse device effects
Measured: 1 year
Mean CGM Glucose
Mean glucose as determined by CGM after 1 year of iLet use
Measured: 1 year
Time < 54 mg/dL
Percentage of time with CGM glucose < 54 mg/dL
Measured: 1 year
Time < 70 mg/dL
Percentage of time with CGM glucose < 70 mg/dL
Measured: 1 year
Time in Range
Percentage of time with CGM glucose 70-180 mg/dL
Measured: 1 year
Time > 180 mg/dL
Percentage of time with CGM glucose > 180 mg/dL
Measured: 1 year
Time > 250 mg/dL
Percentage of time with CGM glucose > 250 mg/dL
Measured: 1 year
Rate of CGM-determined hypoglycemic events
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
Measured: 1 year
Rate of CGM-determined hyperglycemic events
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.
Measured: 1 year
Mean glucose coefficient of variation
Mean CGM glucose Intrasubject coefficient of variation
Measured: 1 year
Time in BG-Run mode
Percent of time spent in BG-run mode
Measured: 1 year
Time in BG-run mode for longer than 4 hours
Percent of time spent in BG-run mode episodes longer than 4 hours
Measured: 1 year
Severe Hypoglycemia During BG-run mode
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
Measured: 1 year
DKA During BG-run mode
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
Measured: 1 year
Unanticipated Adverse Device Effects during BG-run mode
Rate of unanticipated adverse device effects during BG-run mode
Measured: 1 year
Average duration of BG-run mode episodes
Average duration of BG-run mode episodes
Measured: 1 year
Percentage of time insulin suspended during BG-Run episodes >4 hours
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
Measured: 1 year
Mean CGM glucose at time of entry into BG-run episodes >4 hours
Mean CGM glucose at the time of entry into BG-run mode episodes that lasted more than 4 hours
Measured: 1 year
Mean CGM glucose at time of exit from BG-run episodes >4 hours
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
Measured: 1 year
Insulin TDD
Insulin total daily dose (u/kg/day)
Measured: 1 year
Mean Baseline HbA1c of all Participants
The last available baseline HbA1c value (when available) will be reported as the mean ± standard deviation.
Measured: Baseline
Mean HbA1c on iLet
The last available HbA1c value during the study period (when available) will be reported as the mean ± standard deviation.
Measured: 1 year or final available during study period
Mean change in HbA1c
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.
Measured: 1 year or final available during study period compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start1 May 2024
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,875 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Beta Bionics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Scripps Research Institute
- Responsible party
- Sponsor
- Investigators
- Steven J Russell, MD, PhD, Principal investigator, Beta Bionics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06891898
- Sponsor's protocol ID
- PS240001
- Status last verified
- Sep 2026
- First submitted
- 18 Mar 2025
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: It has not yet been decided if IPD will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iLet Dosing Decision Software Postmarket Surveillance Plan (PS240001): The iLet Experience Study
- ClinicalTrials.gov ID
- NCT06891898
- Acronym / sponsor ID
- PS240001
- Conditions
- Type 1 Diabetes
- Keywords
- diabetes, postmarket registry, iLet Bionic Pancreas, Beta Bionics, iLet Dosing Decision Software
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,875 participants (estimated)
- Lead sponsor
- Beta Bionics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- The Scripps Research Institute
- Study start
- 1 May 2024 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 24 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| iLet Bionic Pancreas | – | Device: iLet Dosing Decision Softwareusers of the iLet Bionic Pancreas installed with the iLet Dosing Decision Software |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (12 listed)
- Users must meet the following criteria in order to be enrolled in the study:
Key exclusion criteria (5 listed)
- Users with the following characteristics will not be considered candidates for the study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iLet Dosing Decision SoftwareAlso: iLet Bionic PancreasInteroperable alternate glycemic controller | Device | iLet Bionic Pancreas |
Primary outcome
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
25 secondary outcomes
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
Time in BG-Run mode
Time frame: 1 year
Time in BG-run mode for longer than 4 hours
Time frame: 1 year
Severe Hypoglycemia During BG-run mode
Time frame: 1 year
DKA During BG-run mode
Time frame: 1 year
Unanticipated Adverse Device Effects during BG-run mode
Time frame: 1 year
Average duration of BG-run mode episodes
Time frame: 1 year
Percentage of time insulin suspended during BG-Run episodes >4 hours
Time frame: 1 year
Mean CGM glucose at time of entry into BG-run episodes >4 hours
Time frame: 1 year
Mean CGM glucose at time of exit from BG-run episodes >4 hours
Time frame: 1 year
Insulin TDD
Time frame: 1 year
Mean Baseline HbA1c of all Participants
Time frame: Baseline
Mean HbA1c on iLet
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: Undecided. It has not yet been decided if IPD will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Steven J Russell, MD, PhD principal investigator
Beta Bionics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes, run by Beta Bionics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Courtney Balliro, BS RN (978-500-2456, cballiro@betabionics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severe Hypoglycemia/cognitive impairment (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.