ClinicalTrials.gg
Sign In
Not yet recruitingNCT07911566iLet FCLUpdated Nov 2, 2026

Safety and Efficacy of the Fully Closed Loop iLet Bionic Pancreas in Adults With Type 1 and Type 2 Diabetes

An interventional study of iLet FCL in Diabetes (Insulin-requiring, Type 1 or Type 2), sponsored by Beta Bionics, Inc.. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.

Sponsored by Beta Bionics, Inc. · Not applicable, Interventional, and Treatment

Updated Nov 2, 2026Newly registeredGo to Updates ↓

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Phase
Not applicable
Study type
Interventional
Enrollment
400
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Diabetes (Insulin-requiring, Type 1 or Type 2)

Browse trials for

03

In context

Diabetes Mellitus

8,291 studies on the registry are indexed under Diabetes Mellitus; 1,075 are open to participants now.

This study's planned enrollment of 400 is above the median of 80 across 6,024 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Beta Bionics, Inc. is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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
  • 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

Exclusion criteria

Exclusion Criteria:

  • Unable to provide
  • 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 , in the investigator's opinion
  • 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
  • Most recent (within the last 2 years) estimated (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
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
400 participants (estimated)

Study arms

  • Experimental
    Type 1 Diabetes Arm

    Type 1 Diabetes using iLet FCL for 13 weeks

    Device: iLet FCL

  • Experimental
    Type 2 Diabetes Arm

    Type 2 Diabetes using iLet FCL for 13 weeks

    Device: iLet FCL

Interventions

  • DeviceiLet FCL

    iLet FCL

06

What researchers measure

Primary outcomes

  1. HbA1c change from baseline

    Time frame: 13 weeks

  2. Rate of severe hypoglycemia requiring assistance to actively administer treatment

    Time frame: 13 weeks

  3. Rate of severe hypoglycemia resulting in seizure/loss of consciousness

    Time frame: 13 weeks

  4. Rate of hyperosmolar hyperglycemic syndrome (HHS) or diabetic ketoacidosis (DKA)

    Time frame: 13 weeks

Secondary outcomes

  1. % time < 54 mg/dL

    Time frame: 13 weeks

Other outcomes

  1. Mean glucose

    Time frame: 13 weeks

  2. % time 70-180 mg/dL

    Time frame: 13 weeks

  3. % time > 180 mg/dL

    Time frame: 13 weeks

  4. % time > 250 mg/dL

    Time frame: 13 weeks

  5. Standard deviation of glucose

    Time frame: 13 weeks

  6. % time < 70 mg/dL

    Time frame: 13 weeks

  7. Coefficient of variation of glucose

    Time frame: 13 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No — Participant data will be deidentified for analysis

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Jul 2027, 8 months later.

Of 160 industry-sponsored interventional studies with no phase under Diabetes Mellitus, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 26. This study's planned 8 months is below that.

Counting every sponsor, half of 1,744 studies reached it within 21 months; a quarter within 9 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 27, 2026
First posted
Nov 2, 2026
StartEst.
Nov 2026
Primary completionEst.
Jul 2027
CompletionEst.
Jul 2027
Last update
Nov 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 2, 2026
Show all 1 update
  1. Nov 2, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07911566
Lead sponsor
Beta Bionics, Inc.
Collaborators
Castor EDC
Responsible party
Sponsor
First posted
Nov 2, 2026
Start date
Nov 2026 (estimated)
Primary completion
Jul 2027 (estimated)
Completion
Jul 2027 (estimated)
Last update
Nov 2, 2026

Study contacts

Courtney Balliro
Contact
bbfcl@betabionics.com
978-500-2456
Steven Russell, MD PhD
principal investigator · Beta Bionics

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Diabetes Mellitus →

Other studies from this sponsor

Beta Bionics, Inc.

Start the discussion