Clinical trial NCT02199028: Hyaluronidase Effect on Infusion Set Life
Official title: Evaluation of Glucose Sensor and Insulin Infusion Set Failures: Hyaluronidase Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 1 Diabetes Mellitus
Keywords: hyaluronidase
infusion sets
insulin pump
Continuous glucose monitor
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: University of Colorado, Denver
First posted: 2014-07-24
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Detailed description: The investigators would like to see if the use of hyaluronidase will improve insulin infusion set survival and improve the onset of insulin action. The investigators will also assess the accuracy of the Dexcom G4P sensors with extended site use beyond the 7 day FDA approved time frame.

The use of sensor information combined with the knowledge of infused insulin from pump therapy could potentially help us detect when an infusion set is beginning to fail. Information from the sensor function to the point of failure, and sensor function in response to Tylenol may allow us to develop special formulas to determine when a sensor is not working well. This will be very important for creating an artificial pancreas.

Thirty subjects will be enrolled. Fifteen patients from each of the two sites: Stanford University and University of Colorado.

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

Primary outcomes:
measure: Duration of Insulin Infusion Set Wear as a Measure of the Effect of Hyaluronidase Treatment
timeFrame: Up to 4 weeks
Secondary outcomes:
measure: Maximum Glycemic Excursion
timeFrame: Up to 24 hours post infusion
measure: Pain Tolerability of Hyaluronidase Injections
timeFrame: Up to 4 weeks
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Bruce A Buckingham, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Patel PJ, Benasi K, Ferrari G, Evans MG, Shanmugham S, Wilson DM, Buckingham BA. Randomized trial of infusion set function: steel versus teflon. Diabetes Technol Ther. 2014 Jan;16(1):15-9. doi: 10.1089/dia.2013.0119. Epub 2013 Oct 3.
citation: Muchmore DB, Vaughn DE. Accelerating and improving the consistency of rapid-acting analog insulin absorption and action for both subcutaneous injection and continuous subcutaneous infusion using recombinant human hyaluronidase. J Diabetes Sci Technol. 2012 Jul 1;6(4):764-72. doi: 10.1177/193229681200600405.
citation: Clausen TS, Kaastrup P, Stallknecht B. Effect of insulin catheter wear-time on subcutaneous adipose tissue blood flow and insulin absorption in humans. Diabetes Technol Ther. 2009 Sep;11(9):575-80. doi: 10.1089/dia.2009.0058.
citation: DeSalvo DJ, Ly TT, Wadwa RP, Messer L, Westfall E, Gopisetty D, Hanes S, von Eyben R, Maahs DM, Buckingham BA. Continuous Glucose Sensor Survival and Accuracy Over 14 Consecutive Days. Diabetes Care. 2016 Aug;39(8):e112-3. doi: 10.2337/dc16-0796. Epub 2016 May 23. No abstract available.