A Study of LY900014 and Insulin Lispro With an External Continuous Subcutaneous Insulin Infusion System in Adult Participants With Type 1 Diabetes
Condition: Diabetes Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: LY900014; Insulin lispro
Intervention description: Administered by CSII; Administered by CSII
Intervention MeSH terms: Insulin Lispro
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: insulin pump

Summary:

      The purpose of this study is to evaluate the compatibility and safety of LY900014 and insulin
      lispro with an external continuous subcutaneous insulin infusion system in adult participants
      with type 1 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with type 1 diabetes and have been using insulin continuously for at least
             12 months.

          -  Using an insulin pump with 'rapid-acting insulin' for at least 6 months and using the
             same rapid-acting insulin for at least the past 30 days.

          -  Have experience using Continuous Glucose Monitoring (CGM) or Flash Glucose Monitoring
             (FGM) for at least 60 days during the past 12 months.

          -  Have hemoglobin A1c values ≤8.5%, as determined by the central laboratory at
             screening.

          -  Have a body mass index (BMI) of ≤35 kilograms per meter squared at screening.

          -  Have been using the MiniMed 530G or 630G (US) or the MiniMed 640G (EU) insulin pump
             for at least the past 30 days.

        Exclusion Criteria:

          -  Have had more than 1 emergency treatment for very low blood glucose in the last 6
             months.

          -  Have had more than 1 emergency treatment for poor glucose control (hyperglycemia or
             diabetic ketoacidosis) in the last 6 months.

          -  Have significant insulin resistance defined as having received a total daily dose of
             insulin >1.2 units per kilogram (U/kg) at screening, as determined by the average
             total daily insulin dose over the 3 days prior to screening divided by weight in
             kilograms based on investigator review of the participant's pump history.

          -  Have significant lipohypertrophy, lipoatrophy, or scars within the subcutaneous tissue
             in areas of infusion or have a history of abscess at an infusion site within the last
             90 days prior to screening.

          -  Are receiving any oral or injectable medication intended for the treatment of diabetes
             mellitus other than rapid-acting analog insulin via CSII in the 90 days prior to
             screening. Occasional pen or syringe injection of insulin is allowed, for example, due
             to pump malfunction or unexplained hyperglycemia not responsive to pump correction
             bolus.

          -  Taking certain diabetes medications that are not allowed for study participation.

          -  Have major problems with heart, kidneys, liver, or have a blood disorder.

          -  Have had or are now being treated for certain types of cancer that prevents study
             participation.