Hyaluronidase Effect on Infusion Set Life

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Hyaluronidase

Control

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring hyaluronidase, infusion sets, insulin pump, Continuous glucose monitor

Eligibility Criteria

12 Years - 45 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Stanford University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Hyaluronidase, Then Control

Control, Then Hyaluronidase

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT02199028

First Posted

January 28, 2014

Last Updated

September 24, 2019

Sponsor

Stanford University

Collaborators

University of Colorado, Denver

1. Study Identification

Unique Protocol Identification Number

NCT02199028

Brief Title

Hyaluronidase Effect on Infusion Set Life

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Completed

Study Start Date

July 2014 (undefined)

Primary Completion Date

March 2015 (Actual)

Study Completion Date

March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stanford University

Collaborators

University of Colorado, Denver

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 1 Diabetes Mellitus

Keywords

hyaluronidase, infusion sets, insulin pump, Continuous glucose monitor

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Hyaluronidase, Then Control

Arm Type

Experimental

Arm Description

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.

Arm Title

Control, Then Hyaluronidase

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Hyaluronidase

Other Intervention Name(s)

Hylenex

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Control

Intervention Description

No hyaluronidase administered into insulin infusion set.

Primary Outcome Measure Information:

Title

Duration of Insulin Infusion Set Wear as a Measure of the Effect of Hyaluronidase Treatment

Description

Average (mean) days of wear are presented for each group. A longer period of wear was considered a better outcome.

Time Frame

Up to 4 weeks

Secondary Outcome Measure Information:

Title

Maximum Glycemic Excursion

Description

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.

Time Frame

Up to 24 hours post infusion

Title

Pain Tolerability of Hyaluronidase Injections

Description

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.

Time Frame

Up to 4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bruce A Buckingham, MD

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanford University

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

No

Citations:

PubMed Identifier

24090124

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.

Results Reference

background

PubMed Identifier

22920800

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.

Results Reference

background

PubMed Identifier

19764836

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.

Results Reference

background

PubMed Identifier

27222506

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.

Results Reference

derived

Type 1 Diabetes Mellitus

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial