Product Info

maximum of 19 hours. The observation period included the suspension period, the
insulin resumption period, and if applicable, an insulin resuspension after insulin
delivery resumed.
Five adverse events were reported during the study. Four adverse events were
neither device nor procedure related. One adverse event was procedure related.
Data from this in-clinic study demonstrated that the Suspend before low feature is
safe to use. Study success criteria, as defined in the protocol, were met (i.e. there
were no device related serious adverse events, no diabetic ketoacidosis events
related to the Suspend before low feature, and no unanticipated adverse device
effects).
The second level of SmartGuard technology was evaluated under a pivotal, single-
arm, multi-center, home and hotel study in subjects with type 1 diabetes on
insulin pump therapy. Study subjects included persons aged 14 to 75 years
diagnosed with type 1 diabetes mellitus for two years or more that had used
pump therapy for more than 6 months prior to screening. Study subjects had an
HbA1C value of less than 10.0% at the time of screening.
This study consisted of a 2-week run-in phase and a 3-month study phase. A total
of 124 subjects used the MiniMed 670G System in Manual Mode only first, before
transitioning to Auto Mode during the study phase. In addition to system use at
home, the study phase included a 6-day and 5-night hotel stay during which
subjects underwent daytime and nighttime FST for a total of approximately 24
hours. Subjects were allowed to eat as they normally would, and participated in a
daily exercise or activity regimen for a minimum of 4 hours per day, spread
throughout the day, during the hotel stay. Two of the 124 subjects did not
participate in a hotel stay. One of these two subjects withdrew from the study.
The MiniMed 670G System was used for 12,389 patient days. No serious adverse
events, diabetic ketoacidosis (DKA), or severe hypoglycemia were reported during
the study. Compared to Manual Mode use during the run-in phase, use of the
system was associated with a higher percentage of SG values within the range of
71–180 mg/dL and lower percentage of SG values in the low and high glucose
ranges. A change in mean A1C from 7.4 ± 0.91 (median 7.3) at the start of the
study to 6.9 ± 0.61 (6.8) at the end of the study was observed. This observation
was associated with a modest increase in the mean total daily dose of insulin (47.5
baseline to 50.9) and mild increase in mean weight (76.9 baseline to 77.6).
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670G Performance Data and Technical Information
670G Performance Data and Technical Information 325