CMS Closed-Loop Blood Glucose Control Device (CBGCD) Form

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.