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Artificial Pancreas Device Systems

Use of a U.S. Food and Drug Administration (FDA) approved automated insulin delivery system (artificial pancreas device system) with a low-glucose suspend feature may be considered medically necessary in patients with type 1 diabetes who meet all of the following criteria:Age 6 years and older

Glycated hemoglobin level between 5.8% and 10.0%

Used insulin pump therapy for more than 6 months

At least 2 documented nocturnal hypoglycemic events in a 2-week period.

Use of a FDA approved automated insulin delivery system (artificial pancreas device system) designated as a hybrid closed-loop insulin delivery system (with low glucose suspend and suspend before low features) may be considered medically necessary in patients with type 1 diabetes who meet all of the following criteria:

Over age 6 years AND

Glycated hemoglobin level between 5.8% and 10.0%

Used insulin pump therapy for more than 6 months

At least 2 documented nocturnal hypoglycemic events in a 2-week period.

OR

Age 2 to 6 years AND

Clinical diagnosis of type 1 diabetes for 3 months or more

Used insulin pump therapy for more than 3 months

Glycated hemoglobin level <10.0% Minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8 units Use of an automated insulin delivery system (artificial pancreas device system) is investigational for individuals who do not meet the above criteria. Use of an automated insulin delivery system (artificial pancreas device system) not approved by the FDA is investigational.

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