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Suspend on low event occurs, you can choose to continue to keep insulin
suspended, or you can choose to resume insulin delivery. When a Suspend
before low occurs, insulin delivery will automatically resume when the sensor
glucose (SG) levels recover. The Suspend on low and Suspend before low
features are optional features available when the system is in Manual Mode.
The second level of SmartGuard technology automatically calculates insulin
dose using CGM data, referred to as Auto Mode. The Auto Mode feature can
automatically increase or decrease the amount of insulin delivered based on
sensor values. Elevated SG readings result in increased delivery rates and
decreased SG values result in decreased insulin delivery rates.
During Auto Mode operation, the user must deliver meal boluses by entering the
estimated amount of carbohydrates for meals at the time they are eaten. Failure to
deliver meal boluses in association with meals during Auto Mode operation can
result in significant post meal hyperglycemia.
Since adjustments to insulin delivery rates when the system is in Auto Mode are
based on SG readings, it is critical to monitor blood glucose (BG) values using a
home glucose meter regardless of whether the system is operating in the Manual
Mode or the Auto Mode. If these home glucose meter measurements indicate
hypoglycemia or hyperglycemia, you must follow your physician’s instruction for
treating these conditions and you should not rely on the MiniMed 670G System to
automatically restore your glucose levels to normal.
The SmartGuard technology contains two insulin delivery suspend options:
Suspend on low and Suspend before low. The Suspend on low was previously
evaluated and is currently available on commercially available pumps
(MiniMed 530G Pump and MiniMed 630G Pump).
The Suspend before low feature was evaluated for safety in a multi-center,
single-arm, in-clinic study. Study subjects included persons aged 14 to 75 years
diagnosed with type 1 diabetes mellitus who were on pump therapy at the time
of screening. A total of 71 subjects were subjected to hypoglycemic induction,
followed by an observation period. For hypoglycemic induction, the target was set
to 65 mg/dL, using the rate of change basal increase algorithm. Suspend before
low was activated with the Low Limit setting for Suspend before low ON set to
65 mg/dL, and the subject was observed with frequent sample testing (FST) for a
324 Chapter 17