Hyaluronidase Effect on Infusion Set Life
Trial ID or NCT#
NCT02199028
Status
NOT RECRUITING
Purpose
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.
Official Title
Evaluation of Glucose Sensor and Insulin Infusion Set Failures: Hyaluronidase Study
Eligibility Criteria
Ages Eligible for Study: 12 Years to 45 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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
Investigator(s)
Bruce Buckingham
Endocrinologist
Professor of Pediatrics (Endocrinology) at the Lucile Salter Packard Children's Hospital, Emeritus
View on ClinicalTrials.gov
