| Trial ID: | L6854 |
| Source ID: | NCT02199028
|
| Associated Drug: |
Hyaluronidase
|
| Title: |
Hyaluronidase Effect on Infusion Set Life
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT02199028/results
|
| Conditions: |
Type 1 Diabetes Mellitus
|
| Interventions: |
DRUG: Hyaluronidase|OTHER: Control
|
| Outcome Measures: |
Primary: 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: 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., Up to 24 hours post infusion|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., Up to 4 weeks
|
| Sponsor/Collaborators: |
Sponsor: Stanford University | Collaborators: University of Colorado, Denver
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
30
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2014-07
|
| Completion Date: |
2015-03
|
| Results First Posted: |
2019-10-11
|
| Last Update Posted: |
2019-10-11
|
| Locations: |
Stanford University, Stanford, California, 94305, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT02199028
|
