Product Info

aged 7 to 13 years of age diagnosed with type 1 diabetes mellitus and who were
on pump therapy for more than 6 months prior to screening. All study subjects
had an HbA1C less than 10.0% at the time of screening.
The first level of SmartGuard technology included evaluation of the "Suspend
before low" feature. A total of 105 subjects were asked to exercise in an in-clinic
setting, in order to lower blood sugars sufficiently to trigger Suspend before low.
Activation was followed by an observation period to ensure subject safety. The
target for Suspend before low was set to 65 mg/dL. Subjects underwent FST for a
maximum of 12 hours, which included the exercise period, insulin suspension, and
approximately 4 hours after resumption of insulin delivery (which may also have
included insulin resuspension).
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 the evaluation of Auto Mode,
which was accomplished during the 3-month study phase. A total of 105 subjects
first used the MiniMed 670G System in Manual Mode (approximately 2 weeks
during the run-in phase and 1 additional week at the start of the study phase),
before transitioning to Auto Mode at specific points in time during the study
phase. The timing of the transition to Auto Mode was based on the scheduling of
a 6-day and 5-night hotel or house stay during the study phase. At the hotel or
house, 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. All subjects participated in a hotel or house stay and finished
the study. During this study, the MiniMed 770G System was used for over 15,353
patient days (including the 2-week run-in phase and the 3-month study phase)
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 SG
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 7.9±0.8 (median 7.9) at the start of study
■
670G Performance Data and Technical Information
670G Performance Data and Technical Information 349