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Type 1 Diabetes MellitusPhase 1NCT02199028

Hyaluronidase Effect on Infusion Set Life

A Phase 1 study testing Hyaluronidase in people with Type 1 Diabetes Mellitus, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 12 to 45 years
Conditions the study is for
Type 1 Diabetes Mellitus
What is being tested?
Hyaluronidase
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
Jul 2014to Mar 2015
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 45 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Stanford University

    Stanford, California, 94305

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Hyaluronidase, Control
Keywords
hyaluronidase, infusion sets, insulin pump, Continuous glucose monitor
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HyaluronidaseDrug

    Also called Hylenex

    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.

  • ControlOther

    No hyaluronidase administered into insulin infusion set.

Study groups in NCT02199028
Study groupRoleWhat they receive
Hyaluronidase, Then ControlExperimentalParticipants 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.
Receives: Drug: Hyaluronidase; Other: Control
Control, Then HyaluronidaseExperimentalParticipants 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.
Receives: Drug: Hyaluronidase; Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 4 weeks

Secondary outcomes (2)

  1. 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.

    Measured: Up to 24 hours post infusion

  2. 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.

    Measured: Up to 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2014 (estimated)
  2. Study startJul 2014
  3. Primary completionMar 2015
  4. Study completionMar 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02199028
Sponsor's protocol ID
28949
Other IDs
JDRF 17-2013/471
Status last verified
Sep 2019
First submitted
28 Jan 2014
Last updated
11 Oct 2019
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 24090124

  • 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.

    PubMed 22920800

  • 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.

    PubMed 19764836

  • 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.

    PubMed 27222506

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Hyaluronidase in people with Type 1 Diabetes Mellitus, run by Stanford University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Duration of Insulin Infusion Set Wear as a Measure of the Effect of Hyaluronidase Treatment (time frame: Up to 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02199028, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2019.

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