This is a pilot outpatient study conducted at Stanford to obtain preliminary data on how Fiasp® works in a closed-loop system and to determine if any changes need to be made to the 670G pump to optimize the use of Fiasp®.
This will be a randomized cross-over blinded study and to see how the 670G pump responds to the introduction of Fiasp® insulin. Subjects enrolled in the study will have a 2 week period of optimization with weekly assessments of their Carelink download before entering the blinded phase of the study. They will use their usual home insulin during the optimization phase. They will then be started on their first blinded insulin (aspart or Fiasp®) which they will use for 2 weeks, before they cross-over to the other insulin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
27
Stanford University
Palo Alto, California, United States
Stanford
Palo Alto, California, United States
Percentage of Time in Range: Sensor Glucose Values Between 70-180 mg/dl
Measured as percentage of time in range (days).
Time frame: 7 days (during 2nd half of 2-week intervention period)
Percentage of Time in Range: Sensor Glucose Readings <70 mg/dl
Percentage of time in range (days) as a measure of hypoglycemia.
Time frame: 7 days (during 2nd half of 2-week intervention period)
Mean Sensor Glucose in mg/dl
Mean sensor data over the second week of using a randomized, blinded insulin.
Time frame: 7 days (during 2nd half of 2-week intervention period)
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