Hyaluronidase Effect on Infusion Set Life

Type 1 Diabetes Mellitus Clinical Trial

Official title:

Evaluation of Glucose Sensor and Insulin Infusion Set Failures: Hyaluronidase Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02199028
• Other study ID #: 28949
• Secondary ID: JDRF 17-2013/471
• Status: Completed
• Phase: Phase 1
• Start date: July 2014
• Est. completion date: March 2015

Study information

• Verified date: September 2019
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Drug:
• Hyaluronidase
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.

Other:
• Control
No hyaluronidase administered into insulin infusion set.

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	University of Colorado Denver School of Medicine Barbara Davis Center

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of Insulin Infusion Set Wear as a Measure of the Effect of Hyaluronidase Treatment	Average (mean) days of wear are presented for each group. A longer period of wear was considered a better outcome.	Up to 4 weeks
Secondary	Maximum Glycemic Excursion	The effects of hyaluronidase on post-prandial glucodymamic parameters is presented as the estimated glycemic excursion, a composite value which was calculated based on peak glucose concentration (Cmax), time to Cmax (Tmax), time to early half-maximal glucose concentration (t50%), time to late t50%, and area under the curve (AUC) of glucose concentrations at time intervals of 120 and 240 minutes, with or without hyaluronidase. Estimated glycemic excursion for a patient with Type 1 diabetes that is less than 80 mg/dL is considered acceptable.	Up to 24 hours post infusion
Secondary	Pain Tolerability of Hyaluronidase Injections	Patients recorded pain experience at the infusion site (at time of injection and pain each day of wear) in subject diaries on a 0-5 pain scale (0 = no pain and 5 = worst pain imaginable).; The number of diary entries are presented by scale category.	Up to 4 weeks