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

Prior treatment

• 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

Other illness

• For people with type 2 diabetes: Current use of sulfonylurea or meglitinide medications
• 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
• 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.

Lab values

• For people with type 1 diabetes: Current use of any non insulin glucose lowering medications other than metformin or GLP-1 receptor agonists
• Known hemoglobinopathy or condition/medication use that would interfere with accurate determination of HbA1c, in the investigator's opinion
• Most recent (within the last 2 years) estimated glomerular filtration rate (eGFR) \< 30 ml/min OR currently in renal failure on dialysis

Other

• Unable to provide informed consent
• Unable to safely comply with study procedures and reporting requirements
• Pregnant or lactating, planning to become pregnant during the study, or sexually active without the use of appropriate contraception
• 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

• 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