Hyaluronidase Effect on Infusion Set Life
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|ClinicalTrials.gov Identifier: NCT02199028|
Recruitment Status : Completed
First Posted : July 24, 2014
Last Update Posted : April 2, 2015
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Mellitus||Drug: Hyaluronidase||Phase 2 Phase 3|
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.
You are invited to participate in a research study 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. Eligible subjects are those with type 1 diabetes who wear an insulin pump.
Thirty subjects will be enrolled. Fifteen patients from each of the two sites: Stanford University and University of Colorado.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Glucose Sensor and Insulin Infusion Set Failures: Hyaluronidase Study|
|Study Start Date :||July 2014|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||March 2015|
Infuse 1mL Hyaluronidase at time of infusion set placement and again on Day 3
If assigned to hyaluronidase week, subjects will inject 1 milliliter (ml) Hylenex (150 units/ml) into the catheter hub prior to connecting the insulin infusion set. They will then give a catheter fixed prime of 0.7 cc to clear the infusion set of hyaluronidase. On the morning of day 3 during a Hyaluronidase week, a second dose of 1ml Hylenex (150 units/1ml) will be injected through the catheter hub prior to breakfast using the Duo Infusion Set Tubing. They will then reconnect their pump catheter and give a fixed prime of 0.7 cc to clear the infusion set of hyaluronidase.
Other Name: Hylenex
No Intervention: Control
Subjects will not receive Hyaluronidase during this week
- Sensor and infusion set failure [ Time Frame: participants will be followed for 4 weeks as outpatients, including 5 visits to CTRU (prior to enrollment and after each week) ]To generate data sets with sensor and infusion set failure. These data will generate 120 weeks of infusion set data (and we anticipate 72 infusion site failures), and 120 "two week" sensor wears (with an anticipated 72 sensor failures). This will provide sufficient data sets for the initial development of prediction models to detect sensor and infusion set failure to be used in closed-loop artificial pancreas algorithms.
- Hyaluronidase effects on glucodynamics [ Time Frame: participants will be followed for 4 weeks as outpatients, including 5 visits to CTRU (prior to enrollment and after each week) ]Evaluate postprandial glucodynamic parameters for the breakfast meal using sensor glucose values for each day of infusion set wear: 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 versus without hyaluronidase.
- Effect of hyaluronidase on glycemic control [ Time Frame: participants will be followed for 4 weeks as outpatients, including 5 visits to CTRU (prior to enrollment and after each week) ]Evaluate average daily blood glucose (mean +/- standard deviation and median +/- IQR) for each day of infusion set wear with and without hyaluronidase
- Effect of Tylenol on Dexcom G4 sensor glucose values [ Time Frame: Eight hours during week 4 of enrollment ]Once during week 4 at breakfast, we will ask subjects to take acetaminophen in the form of two 500 mg Tylenol Regular Strength tablets and then obtain meter readings at ½ hour, 1 hour, and then 2, 4, 6, and 8 hours after the Tylenol ingestion. During this time they should not use any data from their Dexcom G4P sensors for diabetes management decisions. Subjects will be given a log to documents their blood glucose values.
- Evaluate tolerability of hyaluronidase injections [ Time Frame: participants will be followed for 4 weeks as outpatients, including 5 visits to CTRU (prior to enrollment and after each week) ]
- Pain at time of injection (0-5 pain scale)
- Infusion site erythema each day of wear (measured in mm)
- Infusion site induration each day of wear (measured in mm)
- Pain at infusion site each day of wear (0-5 pain scale)
- Evaluate insulin precipitation in infusion site cannulas via DTZ staining [ Time Frame: After each of the 4 weeks, participants will provide their infusion set catheters for analysis ]We plan to stain insulin infusion set catheter tip with diphenylthiocarbazone (DTZ) to evaluate for insulin precipitation as a potential cause of infusion set failure. DTZ is a chelating ligand that forms photochromic complexes with a variety of metals. It is known to selectively stain pancreatic cells crimson read because of the large amount of zinc in the islets. Catheters will be photographed using a Zeiss Axiovert 200 digital microscope, and photographs of the catheter staining will be analyzed using software for image analysis.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02199028
|United States, California|
|Stanford, California, United States, 94305|
|Principal Investigator:||Bruce A Buckingham, MD||Stanford University|