Hyaluronidase Effect on Infusion Set Life

Completed · Phase 1

Conditions studied: Type 1 Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT02199028

Run by

Stanford University

People needed

30

Starts

2014-07-01

Expected to finish

2015-03-01

Last updated by the study team

2019-10-11

Who can join

Age: 12 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinical diagnosis of type 1 diabetes for at least one year and using an insulin pump for at least 3 months
• Total daily insulin dose of at least 0.4 units/kg/day
• The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.
• Age 12 to 45 years
• Hemoglobin A1c level less than or equal to 10%
• 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
• 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).
• Willingness to eat the same breakfast each morning for the first two weeks of the study
• Willing to take two 500mg tablets of Tylenol Regular Strength and monitor glucose levels at ½, 1, 2, 4, 6, and 8 hours later.
• For females, not currently known to be pregnant
• An understanding of and willingness to follow the protocol and sign the informed consent
• Must be able to understand spoken or written English

You may not qualify if…

• Diabetic ketoacidosis in the past 6 months
• Severe hypoglycemia resulting in seizure or loss of consciousness in the 6 months prior to enrollment
• Known tape allergies
• Current treatment for a seizure disorder
• Cystic fibrosis
• Active infection
• A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as the following examples:
• Inpatient psychiatric treatment in the past 6 months for either the subject or the subject's primary care giver (i.e., parent or guardian)
• Presence of a known adrenal disorder
• 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
• Abuse of alcohol
• Use of an OmniPod insulin infusion pump
• Pregnant or lactating females

Where it is running

• Stanford University — Stanford, California, United States

Full record on ClinicalTrials.gov

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