Open label, randomized 2-period cross-over study comparing two continuous subcutaneous insulin infusion sets ; MiniMed® Pro-set® with BD FlowSmart™ technology and MiniMed® Quick-set®
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Utilization of the MiniMed® Pro-set® to administer the subject's current insulin therapy.
Utilization of the MiniMed® Quick-set® to administer the subject's current insulin therapy.
Compare Pro-set® vs. Quick-set® for non-inferiority for set insertion failures (set removal) due to either occlusion alerts or hyperglycemia
Time frame: 6 hours from time of insertion
Compare Pro-set® vs. Quick-set® for set removals due to hyperglycemia; > 400mg/dl.
Time frame: 6 hours from time of insertion
Compare Pro-set® vs. Quick- set® for set removals due to set failure; hyperglycemia >250mg/dl.
Time frame: 72 hours of set wear that occurs at 6 hours or later after insertion
Compare Pro-set® vs. Quick- set® for set removals at less than 60 hours post insertion.
Time frame: 60 hours post insertion
Compare Pro-set® vs. Quick- set® for duration of wear
Time frame: % reaching 12 hours, % reaching 24 hours, % reaching 36 hours, % reaching 48 hours, % reaching 60 hours, and % reaching 72 hours)
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