Conditions: Type 1 Diabetes Mellitus
Keywords: hyaluronidase infusion sets insulin pump Continuous glucose monitor
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 30
Healthy volunteers: no

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.

Arms:
arm 1: 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 2: 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.

Interventions: intervention 1: Hyaluronidase intervention 2: Control
Intervention descriptions: intervention 1: 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 2: No hyaluronidase administered into insulin infusion set.

Protocol document: