Hyaluronidase Effect on Infusion Set Life

NCT02199028 | Completed Phase 1 Results

• 2 other identifiers: 28949JDRF 17-2013/471
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes Mellitus

Keywords

hyaluronidase; infusion sets; insulin pump; Continuous glucose monitor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Maximum Glycemic Excursion

  Up to 24 hours post infusion

• Pain Tolerability of Hyaluronidase Injections

  Up to 4 weeks

Study Arms (2)

Hyaluronidase, Then Control

EXPERIMENTAL

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; Other: Control

Control, Then Hyaluronidase

EXPERIMENTAL

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; Other: Control

Interventions

Hyaluronidase DRUG

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.

Also known as: Hylenex

Control, Then Hyaluronidase; Hyaluronidase, Then Control

Control OTHER

No hyaluronidase administered into insulin infusion set.

Control, Then Hyaluronidase; Hyaluronidase, Then Control

Eligibility Criteria

• Age: 12 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Sponsors & Collaborators

• Stanford University: lead
• University of Colorado, Denver: collaborator

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (4)

• 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.

  PMID: 24090124 BACKGROUND

• 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.

  PMID: 22920800 BACKGROUND

• 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.

  PMID: 19764836 BACKGROUND

• 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.

  PMID: 27222506 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Hyaluronoglucosaminidase

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Glycoside Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Polysaccharide-Lyases; Carbon-Oxygen Lyases; Lyases

Limitations and Caveats

This was a proof on concept pilot study and included a small number of participants. There was no evidence that hyaluronidase prolonged infusion set wear.

Results Point of Contact

• Title: Dr Bruce Buckingham
• Organization: Stanford University

buckingham@stanford.edu

(408) 356-0911

Study Officials

• Bruce A Buckingham, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: January 28, 2014
• First Posted: July 24, 2014
• Study Start: July 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: October 11, 2019
• Results First Posted: October 11, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)