Hyaluronidase Effect on Infusion Set Life

September 24, 2019 updated by: Bruce A. Buckingham, Stanford University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hyaluronidase, Then Control

Participants assigned to active treatment arm (Hylenex) for weeks 1 and 3.

On weeks 1 and 3 (Hyaluronidase weeks) subjects injected 1 milliliter (ml) Hyaluronidase (150 units/ml) into the catheter hub prior to connecting the insulin infusion set on Day 1 and 3 of infusion set wear.

On weeks 2 and 4 (control weeks) no Hyaluronidase was administered.
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 Names:
  • Hylenex
Other: Control
No hyaluronidase administered into insulin infusion set.
Experimental: Control, Then Hyaluronidase

Participants were first assigned to the control arm. They received active treatment (Hyaluronidase) on weeks 2 and 4.

On weeks 1 and 3 (control weeks) no Hyaluronidase was administered.

On weeks 2 and 4 (Hyaluronidase weeks) subjects injected 1 milliliter (ml) Hyluronidase (150 units/ml) into the catheter hub prior to connecting the insulin infusion set on Day 1 and 3 of infusion set wear.
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 Names:
  • Hylenex
Other: Control
No hyaluronidase administered into insulin infusion set.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Insulin Infusion Set Wear as a Measure of the Effect of Hyaluronidase Treatment
Time Frame: Up to 4 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Glycemic Excursion
Time Frame: Up to 24 hours post infusion
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
Pain Tolerability of Hyaluronidase Injections
Time Frame: Up to 4 weeks

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

University of Colorado, Denver

Investigators

  • Principal Investigator: Bruce A Buckingham, MD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

January 28, 2014

First Submitted That Met QC Criteria

July 21, 2014

First Posted (Estimate)

July 24, 2014

Study Record Updates

Last Update Posted (Actual)

October 11, 2019

Last Update Submitted That Met QC Criteria

September 24, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 28949
  • JDRF 17-2013/471 (Other Grant/Funding Number: JDRF)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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