The Summer Camp Study 2: Blood Glucose Control With a Bi-Hormonal Endocrine Pancreas

Inclusion Criteria

- Age 6-11 years with type 1 diabetes for at least one year

- Diabetes managed using an insulin infusion pump for ≥ three months

- Willing to wear two infusion sets and continuous glucose monitoring (CGM) sensor and
change sets frequently (at least one new glucagon infusion set daily)

- Otherwise healthy (mild chronic disease such as asthma will be allowed if well
controlled that do not require medications that result in exclusion)

Exclusion Criteria

- Unable to provide informed consent, informed assent or parental consent

- Unable to comply with study procedures

- 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 subject

- End stage renal disease on dialysis (hemodialysis or peritoneal dialysis)

- Pregnancy (positive urine human chorionic gonadotropin [HCG])

- History of liver disease that is expected to interfere with the anti-hypoglycemia
action of glucagon (e.g. liver failure or cirrhosis). Other liver disease (i.e. 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 cystic fibrosis, pancreatitis, or other pancreatic disease,
including pancreatic tumor or insulinoma

- History of prolonged QT or arrhythmia, congenital heart disease or current known
cardiac disease

- Acute illness (other than non-vomiting viral illness) or exacerbation of chronic
illness other than type 1 diabetes (T1D) at the time of the study

- Seizure disorder, history of any seizure within the last two years, or ongoing
treatment with anticonvulsants

- 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 second generation anti-psychotic medications, which are
known to affect glucose regulation.

- Electrically powered implants (e.g. cochlear implants, neurostimulators) that might be
susceptible to radio-frequency (RF) interference

- Use of oral (e.g. thiazolidinediones, biguanides, sulfonylureas, glitinides,
dipeptidyl peptidase 4 (DPP-4) inhibitors, sodium-glucose linked transporter 2
(SGLT-2) inhibitors) anti-diabetic medications

- History of adverse reaction to glucagon (including allergy) besides nausea and
vomiting.

- Unwilling or unable to completely avoid acetaminophen during the comparator and bionic
pancreas arms of the study

- History of eating disorder such as anorexia, bulimia, or diabulemia or omission of
insulin to manipulate weight

- History of intentional, inappropriate administration of insulin leading to severe
hypoglycemia requiring treatment

- Any factors that, in the opinion of the principal investigator, would interfere with
the safe completion of the study procedures