Hyaluronidase Effect on Infusion Set Life
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 1
Intervention: Hyaluronidase; Control
Intervention description: 150 units/ml - subjects injected 1 milliliter (ml) into the catheter hub prior to connecting the insulin infusion set on Day 1 and 3 of infusion set wear.; No hyaluronidase administered into insulin infusion set.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 12 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: hyaluronidase; infusion sets; insulin pump; Continuous glucose monitor

Summary:

      This research study examines the effect of hyaluronidase on the length of time of insulin
      infusion set wear. The aim of the study is to improve the length of time that an infusion set
      can be worn by infusing hyaluronidase directly into the insulin infusion site.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Clinical diagnosis of type 1 diabetes for at least one year and using an insulin pump
             for at least 3 months

          2. Total daily insulin dose of at least 0.4 units/kg/day

          3. The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide
             level and antibody determinations are not needed.

          4. Age 12 to 45 years

          5. Hemoglobin A1c level less than or equal to 10%

          6. Willingness to infuse 1 ml of hyaluronidase (Hylenex) into the insulin infusion set
             after insertion on day 1 and day 3 of the week they are assigned to use hyaluronidase

          7. Willingness to use a Silhouette or Comfort insulin infusion set throughout the study.
             The set includes the Duo Infusion Tubing for infusion of hyaluronidase (Hylenex).

          8. Willingness to eat the same breakfast each morning for the first two weeks of the
             study

          9. Willing to take two 500mg tablets of Tylenol Regular Strength and monitor glucose
             levels at ½, 1, 2, 4, 6, and 8 hours later.

         10. For females, not currently known to be pregnant

         11. An understanding of and willingness to follow the protocol and sign the informed
             consent

         12. Must be able to understand spoken or written English

        Exclusion Criteria:

          1. Diabetic ketoacidosis in the past 6 months

          2. Severe hypoglycemia resulting in seizure or loss of consciousness in the 6 months
             prior to enrollment

          3. Known tape allergies

          4. Current treatment for a seizure disorder

          5. Cystic fibrosis

          6. Active infection

          7. A known medical condition that in the judgment of the investigator might interfere
             with the completion of the protocol such as the following examples:

          8. Inpatient psychiatric treatment in the past 6 months for either the subject or the
             subject's primary care giver (i.e., parent or guardian)

          9. Presence of a known adrenal disorder

         10. If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, lack of
             stability on the medication for the past 2 months prior to enrollment in the study

         11. Abuse of alcohol

         12. Use of an OmniPod insulin infusion pump

         13. Pregnant or lactating females