The Bihormonal iLet Bionic Pancreas Feasibility Study

Inclusion Criteria

• Age ≥ 18 years and have had clinical type 1 diabetes for at least one year
• Diabetes managed using an insulin pump for ≥ 3 months
• Prescription medication regimen stable for > 1 month (except for medications that will not affect the safety of the participant and are not expected to affect any outcome of the study, in the judgement of the principal investigator)
• Willing to wear one Dexcom CGM sensor, and up to two steel cannula infusion sets (6 mm Contact Detach) and change infusion sets frequently (if the subject is known not to tolerate steel infusion sets then a plastic set may be used)
• Have used a CGM for at least one cumulative month over the last 24 months
• Willing to stay within a 250-mile radius of the designated base throughout the study. Air travel is not permitted.
• Informed consent obtained before any trial-related activities
• Have a designated contact (an adult ≥ 18 years of age) willing to serve as an emergency contact for them throughout the study.

Exclusion Criteria

• Unable to provide informed consent (e.g. impaired cognition or judgment)
• Unable to safely comply with study procedures and reporting requirements (e.g. impairment of vision or dexterity that prevents safe operation of the iLet, impaired memory, unable to speak and read English)
• Current participation in another clinical trial with administration of investigational drug.
• Current participation in another diabetes-related clinical trial that, in the judgment of the principal investigator, will compromise the results of this study or the safety of the participant
• Previous exposure to dasiglucagon (otherwise known as ZP4207)
• Pregnant (positive urine HCG), breast feeding, plan to become pregnant in the next 12 months, or sexually active without use of contraception
• Subjects must use acceptable contraception for the two weeks prior to the study, throughout the study and for the two weeks following the study.
• Acceptable contraception methods include: Oral contraceptive pills (OCP), Intrauterine Device (IUD, hormonal or copper), Male condoms, Female condoms, Diaphragm or cervical cap with spermicide, Contraceptive patch (such as OrthoEvra), Contraceptive implant (such as Implanon, Nexplanon), Vaginal ring (such as Nuvaring), Progestin shot (such as Depo-Provera), Male partner with a vasectomy proven to be effective by semen analysis
• Current alcohol abuse (intake averaging >4 drinks daily in last 30 days) or other substance abuse (use within the last 3 months of controlled substances other than marijuana without a prescription)
• Unwilling or unable or to avoid use of drugs that may dull the sensorium, reduce sensitivity to symptoms of hypoglycemia, or hinder decision making during the period of participation in the study (use of benzodiazepines or narcotics, even if by prescription, may be excluded according to the judgment of the principal investigator)
• Renal failure on dialysis
• History of cystic fibrosis, pancreatitis, or other pancreatic disease, including pancreatic tumor or insulinoma, or history of complete pancreatectomy
• Coronary artery disease that is not stable with medical management, including unstable angina, angina that prevents moderate exercise (e.g. exercise of intensity up to 6 METS) despite medical management, or within the last 12 months before screening a history of myocardial infarction, percutaneous coronary intervention, enzymatic lysis of a presumed coronary occlusion, or coronary artery bypass grafting
• Abnormal EKG consistent with increased risk of malignant arrhythmia including, but not limited to, evidence of active ischemia, proximal LAD critical stenosis (Wellen's sign), or prolonged QT interval (> 440 ms). Other EKG findings, including stable Q waves, are not grounds for exclusion as long as the participant is not excluded according to other criteria. A reassuring evaluation by a cardiologist after an abnormal EKG finding may allow participation.