The Bihormonal iLet Bionic Pancreas Feasibility Study

Completed · Phase 2/Phase 3

Conditions studied: Type 1 Diabetes Mellitus

In brief

Our objective is to evaluate the function of the bihormonal configuration of the ILet bionic pancreas delivering dasiglucagon when compared to the insulin-only configuration of the ILet bionic pancreas in a home-use study in adults with type 1 diabetes.

Key facts

Study ID

NCT03840278

Run by

Massachusetts General Hospital

People needed

12

Starts

2019-05-15

Expected to finish

2019-07-03

Last updated by the study team

2019-12-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• Congestive heart failure with New York Heart Association (NYHA) Functional Classification III or IV
• History of TIA or stroke in the last 12 months
• History of liver disease that is expected to interfere with the anti-hypoglycemic action of glucagon (e.g. liver failure or cirrhosis). Other liver disease (e.g. active hepatitis, steatosis, active biliary disease, any tumor of the liver, hemochromatosis, glycogen storage disease) may exclude the subject if it causes significant compromise to liver function or may do so in an unpredictable fashion.
• Personal history of pheochromocytoma, MEN 2A, MEN 2B, neurofibromatosis, or von Hippel-Lindau disease
• a.Fractionated metanephrines will be tested to rule out pheochromocytoma in patients with symptoms that could be related to a catecholamine secreting tumor, including those with: Episodic or treatment refractory (requiring 4 or more medications to achieve normotension) hypertension, Paroxyms of tachycardia, pallor or headache
• History of adrenal disease or tumor that has not undergone characterization for endocrine function
• Hypertension with systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg despite treatment
• Recent history of diabetic ketoacidosis (DKA) or severe hypoglycemia in the last 6 months. Severe hypoglycemia is defined as an event that required assistance of another person due to altered consciousness, and required another person to actively administer carbohydrate, glucagon, or other resuscitative actions. This means that the participant was impaired cognitively to the point that he/she was unable to treat himself/herself, was unable to verbalize his/ her needs, was incoherent, disoriented, and/or combative, or experienced seizure or coma.
• History of more than 1 episode of DKA requiring hospitalization in the last 2 years
• History of more than 1 episode of severe hypoglycemia in the last year.
• Untreated or inadequately treated mental illness (indicators would include symptoms such as psychosis, hallucinations, mania, and any psychiatric hospitalization in the last year), or treatment with anti-psychotic medications that are known to affect glucose regulation.

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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