Feasibility Trial Testing the Bionic Pancreas With ZP4207
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Insulin Lispro; ZP4207 (dasiglucagon); Glucagon; iPhone-based bionic pancreas; iLet-based bionic pancreas
Intervention description: Used to lower blood glucose. Commercially available by prescription and is indicated for patients with type 1 diabetes mellitus (T1DM), but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.; A glucagon analog not yet approved by the FDA. Subcutaneous administration in one BP arm.; A hormone normally made by the pancreas to raise blood glucose. Used to treat low blood sugar. Commercially available by prescription and is indicated for patients with T1DM in severe hypoglycemia, but not for use in a BP. Subcutaneous administration in one BP arm.; An experimental device.; An experimental device.
Intervention MeSH terms: Insulin Lispro; Glucagon; Pancrelipase; Pancreatin; Glucagon-Like Peptide 1
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: glucagon; Type 1 diabetes mellitus; Bionic Pancreas; diabetes; iLet; iPhone; Beta Bionics; Anti-hypoglycemia; Glucagon Analog

Summary:

      The purpose of this study was to determine whether the Bionic Pancreas with ZP4207
      (dasiglucagon*) was feasible to improve glycemic control in adults with type 1 diabetes
      mellitus.

      *dasiglucagon is the proposed International Nonproprietary Name (pINN) for ZP4207
    

Eligibility criteria:

        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 liver function tests (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