Feasibility Trial Testing the Bionic Pancreas With ZP4207

This is a single-center, open-label, 2-part, randomized cross-over trial. The trial will
enroll up to 20 adult patients with type 1 diabetes mellitus and will assess the safety and
efficacy of the Bionic Pancreas (BP) using either the iLet or iPhone platform when used with
the glucagon analogue ZP4207 (dasiglucagon) versus Lilly glucagon.

In Part 1, up to 10 patients will participate in two 1-day treatment arms in random order
(iPhone-based BP using ZP4207 (dasiglucagon) and iPhone-based BP using Lilly glucagon)
according to a pre-generated randomization scheme. In Part 2, up to 10 new patients will
participate in two 1-day treatment arms in random order (iLet using ZP4207 (dasiglucagon) and
iLet using Lilly glucagon) according to a pre-generated randomization scheme. Patients can
only participate in 1 part of the trial. One day the BP will use glucagon analogue ZP4207
(dasiglucagon) and the other day the BP will use Lilly glucagon. Subjects will also receive
insulin lispro through the BP on both days. The trial will be conducted at single center, the
Massachusetts General Hospital Diabetes Center in Boston, MA.

Inclusion Criteria:

1. Patients with T1DM for at least 1 year, as defined by the American Diabetes
Association

2. Age ≥ 18 years

3. Prescription medication regimen stable for >1 month (except for medications not
expected to affect trial safety or outcome, in the judgment of the investigator)

4. Diabetes managed using an insulin pump for >=6 months

5. Patients in good health according to age (medical history, physical examination, vital
signs, 12-lead electrocardiograms [ECGs], laboratory assessments), as judged by the
Investigator

Exclusion Criteria:

1. Previous exposure to ZP4207 or adverse reaction to glucagon

2. History of liver disease or current abnormal LFTs

3. Renal failure

4. Anemia

5. History of coronary artery disease or congestive heart failure (class III or IV)

6. History of transient ischemic attack or stroke

7. Seizure disorder

8. Cystic fibrosis, pancreatitis, or any other pancreatic disease besides T1DM

9. Other endocrine disorders

10. Use of oral anti-diabetic medications

11. Electronically powered implants

12. Hypertension (≥160/100 mm Hg despite treatment)

13. Inadequate venous (vein) access as determined by trial nurse or physician at time of
screening