Use of a U.S. Food and Drug Administration (FDA) cleared or approved automated insulin delivery system (artificial pancreas device system) with a low-glucose suspend feature may be considered medically necessary in individuals with type 1 diabetes who meet all of the following criteria:
Age 6 years and older 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.
Use of a FDA cleared or 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 individuals 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 a FDA cleared or approved automated insulin delivery system (artificial pancreas device system) designated as a closed-loop insulin delivery system may be considered medically necessary in individuals with type 1 diabetes who meet all of the following criteria: Age 6 years and older AND Clinical diagnosis of type 1 diabetes for 12 months or more; Using insulin for at least 12 months; Diabetes managed using the same regimen (either pump or multiple daily injections, with or without continuous glucose monitoring) for 3 months or longer. 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 cleared or approved by the FDA is investigational.
