Can an automated pancreas system make type 1 diabetes safer in the real world?
NCT ID NCT06891898
First seen Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time
Summary
This study follows about 1,875 people aged 6 and older with type 1 diabetes who use the iLet Bionic Pancreas, an automated insulin delivery system. Over 12 months, researchers will track serious events like severe low blood sugar and diabetic ketoacidosis to see how the device performs in everyday settings. The goal is to confirm the system's safety and effectiveness outside of controlled clinical trials.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- iLet Dosing Decision Software, also known as the iLet Bionic Pancreas, an automated insulin delivery system
- What this could lead to
- If the software performs well in real-world use, it could support broader adoption of automated insulin delivery, helping people with type 1 diabetes manage their blood sugar with less effort and fewer dangerous lows.
- What could go wrong
- This is an observational study without a comparison group, so it cannot prove the device causes better outcomes. Risks include severe hypoglycemia or diabetic ketoacidosis, which the study will track.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 1,875 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2024
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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
- Ages
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6 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Beta Bionics
RECRUITINGIrvine, California, 92618, United States
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