Diabetes (Insulin-requiring, Type 1 or Type 2)iLet FCLNCT07911566
Safety and Efficacy of the Fully Closed Loop iLet Bionic Pancreas in Adults With Type 1 and Type 2 Diabetes
A study testing iLet FCL in people with Diabetes (Insulin-requiring, Type 1 or Type 2), run by Beta Bionics, Inc..
Trial summary
The goal of this clinical trial is to evaluate the safety and efficacy of the fully closed loop (FCL) iLet automated insulin delivery (AID) System in people ≥18 years old with type 1 diabetes or type 2 diabetes requiring insulin therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes (Insulin-requiring, Type 1 or Type 2)
- What is being tested?
- iLet FCL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Jul 2027
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with type 1 diabetes or with type 2 diabetes and using insulin for at least 90 days at the time of enrollment
- Stable insulin regimen type in the last 90 days prior to enrollment
- Stable insulin doses for the last 30 days prior to enrollment
- Willing to use only compatible rapid-acting or ultra rapid-acting insulin in the iLet for the duration of the study
- Stable regimen of non-insulin glucose lowering medications over the preceding 90 days prior to enrollment
- Stable doses of non-insulin glucose lowering medications over the last 30 days prior to enrollment
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- Willing to not change doses from baseline non-insulin glucose lowering medications during the trial unless required for safety or tolerability purposes
- Willing to not initiate use of any new non-insulin glucose-lowering during the trial
- Able to read and understand English
Who cannot join
- Unable to provide informed consent
- Unable to safely comply with study procedures and reporting requirements
- For people with type 1 diabetes: Current use of any non insulin glucose lowering medications other than metformin or GLP-1 receptor agonists
- For people with type 2 diabetes: Current use of sulfonylurea or meglitinide medications
- Use of medication or supplements that are known to interfere with CGM sensor accuracy and, in the opinion of the treating physician, cannot be discontinued during the study period
- Known hemoglobinopathy or condition/medication use that would interfere with accurate determination of HbA1c, in the investigator's opinion
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- History of cystic fibrosis, diabetes secondary to pancreatitis, or other pancreatic diseases, including pancreatic tumor or insulinoma, or history of complete pancreatectomy
- Tape allergy or skin condition that will preclude use of the study pump or CGM
- Pregnant or lactating, planning to become pregnant during the study, or sexually active without the use of appropriate contraception
- Most recent (within the last 2 years) estimated glomerular filtration rate (eGFR) < 30 ml/min OR currently in renal failure on dialysis
- Current participation in another diabetes-related interventional clinical trial
- Presence of a medical condition or use of a medication that, in the judgment of the site investigator, principal investigator (PI), or medical monitor, could compromise the results of the study or the safety of the participant.
- Unable to follow clinical protocol for the duration of the study or is otherwise deemed unacceptable to participate in the study per the investigator's clinical judgment.
- .Participant is an employee of Beta Bionics, an Investigator or Investigator's study team, or immediate family member
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this clinical trial is to evaluate the safety and efficacy of the fully closed loop (FCL) iLet automated insulin delivery (AID) System in people ≥18 years old with type 1 diabetes or type 2 diabetes requiring insulin therapy. The main questions it aims to answer are:
Do HbA1c levels decrease when using the iLet FCL algorithm?
What medical problems do participants have when using the iLet FCL algorithm?
Participants will use the iLet FCL for 13 weeks, undergo bloodwork, and complete psychosocial questionnaires.
- Being tested
- iLet FCL
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iLet FCLDevice
iLet FCL
| Study group | Role | What they receive |
|---|---|---|
| Type 1 Diabetes Arm | Experimental | Type 1 Diabetes using iLet FCL for 13 weeks Receives: Device: iLet FCL |
| Type 2 Diabetes Arm | Experimental | Type 2 Diabetes using iLet FCL for 13 weeks Receives: Device: iLet FCL |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c change from baseline
Measured: 13 weeks
Rate of severe hypoglycemia requiring assistance to actively administer treatment
Measured: 13 weeks
Rate of severe hypoglycemia resulting in seizure/loss of consciousness
Measured: 13 weeks
Rate of hyperosmolar hyperglycemic syndrome (HHS) or diabetic ketoacidosis (DKA)
Measured: 13 weeks
Secondary outcomes (1)
% time < 54 mg/dL
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study startNov 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes (Insulin-requiring, Type 1 or Type 2)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beta Bionics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Castor EDC
- Responsible party
- Sponsor
- Investigators
- Steven Russell, MD PhD, Principal investigator, Beta Bionics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07911566
- Sponsor's protocol ID
- TP000138
- Acronym
- iLet FCL
- Status last verified
- Oct 2026
- First submitted
- 27 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Participant data will be deidentified for analysis
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of the Fully Closed Loop iLet Bionic Pancreas in Adults With Type 1 and Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT07911566
- Acronym / sponsor ID
- iLet FCL / TP000138
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Beta Bionics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Castor EDC
- Study start
- Nov 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 2 Nov 2026 (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.
The goal of this clinical trial is to evaluate the safety and efficacy of the fully closed loop (FCL) iLet automated insulin delivery (AID) System in people ≥18 years old with type 1 diabetes or type 2 diabetes requiring insulin therapy. The main questions it aims to answer are:
Do HbA1c levels decrease when using the iLet FCL algorithm?
What medical problems do participants have when using the iLet FCL algorithm?
Participants will use the iLet FCL for 13 weeks, undergo bloodwork, and complete psychosocial questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Type 1 Diabetes Arm | Experimental | Device: iLet FCLType 1 Diabetes using iLet FCL for 13 weeks |
| Type 2 Diabetes Arm | Experimental | Device: iLet FCLType 2 Diabetes using iLet FCL for 13 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosed with type 1 diabetes or with type 2 diabetes and using insulin for at least 90 days at the time of enrollment
- Stable insulin regimen type in the last 90 days prior to enrollment
- Stable insulin doses for the last 30 days prior to enrollment
- Willing to use only compatible rapid-acting or ultra rapid-acting insulin in the iLet for the duration of the study
- Stable regimen of non-insulin glucose lowering medications over the preceding 90 days prior to enrollment
Key exclusion criteria (14 listed)
- Unable to provide informed consent
- Unable to safely comply with study procedures and reporting requirements
- For people with type 1 diabetes: Current use of any non insulin glucose lowering medications other than metformin or GLP-1 receptor agonists
- For people with type 2 diabetes: Current use of sulfonylurea or meglitinide medications
- Use of medication or supplements that are known to interfere with CGM sensor accuracy and, in the opinion of the treating physician, cannot be discontinued during the study period
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 FCLiLet FCL | Device | Type 1 Diabetes Arm, Type 2 Diabetes Arm |
Primary outcome
HbA1c change from baseline
Time frame: 13 weeks
Rate of severe hypoglycemia requiring assistance to actively administer treatment
Time frame: 13 weeks
Rate of severe hypoglycemia resulting in seizure/loss of consciousness
Time frame: 13 weeks
Rate of hyperosmolar hyperglycemic syndrome (HHS) or diabetic ketoacidosis (DKA)
Time frame: 13 weeks
1 secondary outcome
% time < 54 mg/dL
Time frame: 13 weeks
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 2 Nov 2026.
- Individual participant dataSharing planned: No. Participant data will be deidentified for analysis
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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 Russell, MD PhD principal investigator
Beta Bionics
Questions about this trial
What is this clinical trial studying?
A study testing iLet FCL in people with Diabetes (Insulin-requiring, Type 1 or Type 2), run by Beta Bionics, Inc..
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 9 inclusion and 14 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: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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 (978-500-2456, bbfcl@betabionics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c change from baseline (time frame: 13 weeks). The study lists 4 primary outcomes in all. 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 2 Nov 2026.