Product Info

diabetes mellitus and who were on pump therapy for more than 90 days prior to
screening. All study subjects had an HbA1C less than 10.0% at the time of
screening visit.
For the first level of SmartGuard technology, the "Suspend before low" feature,
subjects 2-6 years of age were set up but did not participate in frequent sample
testing.
For this study, there were 47 subjects in the 2-6 year old cohort that entered the
run-in phase. During the run-in phase, 1 subject withdrew. Therefore, 46 subjects
in the 2-6 year old cohort entered the study-phase. The second level of
SmartGuard technology, the "Auto Mode" feature, was evaluated during the 3-
month study phase. Subjects 2-6 years of age are not required to participate in a
hotel study. Instead, they will participate in an out-of-home study for 5 consecutive
days, 4-6 hours per day. During that 5 day period, subjects should engage in
significant activity/exercise. Such activities could include utilizing gym play areas
appropriate for toddlers and young children, swimming, and playground games.
Evidence of geographic location and exercise/activity will be documented by daily
photograph. In addition, investigational center staff will be present daily for the 4-6
hours of exercise during the 5 day period.
During this study, the MiniMed 670G System data was collected for subjects 2-6
years old and was used for over 6697 patient days prior to Run-In + Run-In +
Study periods) without any reported device-related serious adverse events, such as
severe hypoglycemia or diabetic ketoacidosis. Compared to Manual Mode used
during the Run-In phase, use of Auto Mode was associated with reduction in mean
sensor glucose values, an increase within the range of 71 to 180 mg/dL and a
lower percentage of glucose values in the hyperglycemic and hypoglycemic
ranges. There was a significant reduction in mean HbA1c from 8.0±0.9% median
8.1) at the baseline to 7.5±0.6 (median 7.5) at the end of study. There was a small
change in mean total daily dose of insulin/kg (0.8±0.1 baseline to 0.8±0.2 end of
study) and modest increase in weight. Weight gain would also be expected for
pediatric patients 2-6 years of age as part of the normal growth process.
CAUTION: Note that since this study did not include a control group,
no claims regarding effectiveness can be made. However, the study
does support that the device is relatively safe for use.
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670G Performance Data and Technical Information
670G Performance Data and Technical Information 373