System and method for mitigating risk in automated medicament dosing
Inventors
Saint, Sean • Rosinko, Michael
Assignees
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Publication Number
US-12551618-B2
Publication Date
2026-02-17
Expiration Date
Abstract
A portable infusion pump can communicate with glucose monitor, such as a continuous glucose monitor (CGM), to receive continuous feedback relating to a user's blood glucose level during insulin or other medicament therapy and can automatically deliver insulin to a user when the CGM data indicates a need for additional insulin. Due to potential unreliability in the correlation of the CGM data to the user's actual blood glucose level, risk mitigation can be employed to limit the amount of extra insulin that can be delivered by the pump in response to the CGM data.
Core Innovation
The invention relates to an ambulatory infusion pump system that communicates with a continuous glucose monitor (CGM) to support insulin therapy with automatically delivered medicament. The system includes an ambulatory infusion pump and a remote control device that receives information from the CGM and uses a processor to monitor the received information. The processor determines, based on the CGM information, that an additional amount of the medicament should be automatically delivered to the user.
A central aspect is mitigating risk from CGM inaccuracy when automatically delivering medicament. The processor reviews one or more parameters relating to mitigating risk in automatically delivering the medicament based on the information received from the CGM. The processor determines whether the additional amount of the medicament can be delivered in view of the one or more risk-mitigation parameters, and causes a delivery mechanism to deliver the additional amount if it is determined that delivery is permitted.
One parameter relating to mitigating risk includes a threshold relating to predicted accuracy of the continuous glucose monitor after which automatic adjustment of the delivery of the medicament is not permitted. In another aspect, a parameter utilizes an algorithm executed by the processor that determines whether or not the additional medicament can be delivered utilizing an estimated current maximum error of the continuous glucose monitor.
Claims Coverage
Two independent claims are provided. Both claims cover an ambulatory infusion pump system with a remote control processor that monitors CGM information to decide on automatic medicament delivery, subject to risk-mitigation parameters based on predicted CGM accuracy or estimated maximum CGM error.
Remote control processor that monitors CGM information to decide automatic delivery with CGM accuracy threshold
An ambulatory infusion pump system with an ambulatory infusion pump and a remote control device whose processor monitors information received from a continuous glucose monitor, determines from the CGM information that an additional amount of the medicament should be automatically delivered, reviews one or more parameters relating to mitigating risk in automatically delivering the medicament based on the CGM information, determines whether the additional amount can be delivered in view of the risk-mitigation parameters, and causes a delivery mechanism to deliver the additional amount when permitted, wherein one risk-mitigation parameter includes a threshold relating to predicted accuracy of the CGM after which automatic adjustment of delivery based on the CGM information is not permitted.
Algorithm-based deliverability decision using estimated current maximum error of the CGM
An ambulatory infusion pump system with an ambulatory infusion pump and a remote control device whose processor monitors information received from a continuous glucose monitor, determines that an additional amount of the medicament should be automatically delivered, reviews one or more parameters relating to mitigating risk based on the CGM information, determines whether the additional amount can be delivered in view of the risk-mitigation parameters, and causes a delivery mechanism to deliver the additional amount if permitted, wherein one risk-mitigation parameter utilizes an algorithm executed by the processor that determines whether or not the additional medicament can be delivered utilizing an estimated current maximum error of the continuous glucose monitor.
The independent claims require a remote control processor that monitors CGM information to decide whether to automatically deliver an additional amount of medicament and risk-mitigation parameters tied to predicted CGM accuracy, including a predicted-accuracy threshold and/or an algorithm that uses an estimated current maximum error of the CGM to determine deliverability.
Stated Advantages
Mitigates risk from continuous glucose monitor inaccuracy in automatically delivering medicament.
Documented Applications
Automatic adjustment and delivery of medicament in insulin therapy using an ambulatory infusion pump system in communication with a continuous glucose monitor as part of an artificial pancreas system / closed-loop or semi-closed-loop therapy.
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