Medicare National Coverage Determinations (NCD) Manual (Pub. 100-03), Ch. 1 § 40.3
Closed-Loop Blood Glucose Control Device (CBGCD)
40.3 - Closed-Loop Blood Glucose Control Device (CBGCD)
(Rev. 1, 10-03-03)
CIM 35-70
The closed-loop blood glucose control device (CBGCD) is a hospital bedside device
designed for short-term management of patients with insulin dependent diabetes mellitus
(Type I). It consists of a rapid on-line glucose analyzer; a computer with a controller for
the calculation and control of the infusion of either insulin or dextrose; a multi-channel
infusion system; and a printer designed to record continuous glucose values and to
provide cumulative totals of the substances infused. Its primary use is for the
stabilization of Type I diabetics during periods of stress, such as trauma, labor and
delivery, and surgery, when there are wide fluctuations in blood sugar levels. It serves to
temporarily correct abnormal blood glucose levels (hyper- or hypo-glycemia) and this
correction is made by infusion of either insulin or dextrose. Its use is generally limited to
a 24- to 48-hour period because of potential complications; (e.g., sepsis, thromboses, and
nonportability, etc.). The CBGCD requires specialized training for use and interpretation
of its diagnostic and therapeutic contribution and continuous observation by specially
trained medical personnel.
Use of the CBGCD is covered for short-term management of insulin dependent diabetics
in crisis situations, in a hospital inpatient setting, and only under the direction of specially
trained medical personnel.