# US 12,178,571 B2 · Method, system and computer program product for CGM-based prevention of hypoglycemia via hypoglycemia risk assessment and smooth reduction insulin delivery > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,178,571 B2 - Document ID: US12178571B2 - Status: Granted - Kind: B2 - Application number: 17/333,161 - Filed: 2021-05-28 - Published: 2021-09-16 - Granted: 2024-12-31 - Earliest claimed: 2009-02-25 - Assignees: University of Virginia Patent Foundation - Applicants: University of Virginia Patent Foundation - Inventors: Boris P. Kovatchev; Marc D. Breton; Stephen D. Patek - Web page: https://patentgrep.com/patent/US12178571B2 ## CPC - A61B 5/14532: {for measuring glucose, e.g. by tissue impedance measurement} - A61B 5/0002: {Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network (endoradiosondes A61B5/07)} - A61B 5/0004: {characterised by the type of physiological signal transmitted} - A61B 5/4839: {combined with drug delivery} - A61B 5/7275: {Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor} - A61B 5/746: {Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms} - A61M 5/1723: {using feedback of body parameters, e.g. blood sugar or pressure} - A61P 3/10: for hyperglycaemia, e.g. antidiabetics - G16H 20/17: delivered via infusion or injection - G16H 40/63: for local operation - G16H 50/20: for computer-aided diagnosis, e.g. based on medical expert systems - G16H 50/30: for calculating health indices; for individual health risk assessment - G16H 50/50: for simulation or modelling of medical disorders - G16H 40/67: for remote operation - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS - G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA ## Abstract An aspect of an embodiment or partial embodiment of the present invention (or combinations of various embodiments in whole or in part of the present invention) comprises, but not limited thereto, a method and system (and related computer program product) for continually assessing the risk of hypoglycemia for a patient and then determining what action to take based on that risk assessment. A further embodiment results in two outputs: (1) an attenuation factor to be applied to the insulin rate command sent to the pump (either via conventional therapy or via open or closed loop control) and/or (2) a red/yellow/green light hypoglycemia alarm providing to the patient an indication of the risk of hypoglycemia. The two outputs of the CPHS can be used in combination or individually. ## Claims ### Claim 1 A method of preventing or mitigating hypoglycemia in a subject, the method comprising: receiving measurements from a metabolic measurement device providing direct metabolic measurements of a subject; assessing a risk of hypoglycemia in the subject based at least on the received measurements from the metabolic measurement device providing the direct metabolic measurements of the subject; determining an insulin attenuation factor, the determination of the insulin attenuation factor occurring after the assessing of the risk of hypoglycemia; providing one or more options as an output addressing the assessed risk of hypoglycemia in the subject, the output instructing the subject to: a) take no action; b) attenuate insulin delivery using the determined insulin attenuation factor; c) take additional intervention; or d) attenuate insulin delivery using the determined insulin attenuation factor and take additional intervention. ### Claim 2 (depends on 1) The method of claim 1, comprising: calculating the attenuation factor based on the assessed risk of hypoglycemia. ### Claim 3 (depends on 2) The method of claim 2, comprising: implementing a safety supervision function that calculates the attenuation factor. ### Claim 4 (depends on 1) The method of claim 1, comprising: evaluating a risk of hypoglycemia based on the assessed risk of hypoglycemia. ### Claim 5 A system for preventing or mitigating hypoglycemia in a subject, the system comprising one or more processors configured for: receiving measurements from a metabolic measurement device providing direct metabolic measurements of a subject; assessing a risk of hypoglycemia in the subject based at least on the received measurements from the metabolic measurement device providing the direct metabolic measurements of the subject; determining an insulin attenuation factor, the determination of the insulin attenuation factor occurring after the assessing of the risk of hypoglycemia; providing one or more options as an output addressing the assessed risk of hypoglycemia in the subject, the output instructing the subject to: a) take no action; b) attenuate insulin delivery using the determined insulin attenuation factor; c) take additional intervention; or d) attenuate insulin delivery using the determined insulin attenuation factor and take additional intervention. ### Claim 6 (depends on 5) The system of claim 5, wherein: the one or more processors include a glucose meter, an insulin pump, an artificial pancreas, an insulin device, a personal computer, a PDA, a netbook, a laptop, and/or a cellular telephone. ### Claim 7 (depends on 5) The system of claim 5, wherein: the one or more processors calculates the attenuation factor based on the assessed risk of hypoglycemia. ### Claim 8 (depends on 7) The system of claim 7, wherein: the one or more processors implements a safety supervision function that calculates the attenuation factor. ### Claim 9 (depends on 5) The system of claim 5, wherein: the one or more processors evaluates a risk of hypoglycemia based on the assessed risk of hypoglycemia. ### Claim 10 A non-transitory computer readable recording medium encoded with a computer program including instructions causing preventing or mitigating hypoglycemia in a subject via one or more processors, the program causing the one or more processors to: receive measurements from a metabolic measurement device providing direct metabolic measurements of a subject; assess a risk of hypoglycemia in the subject based at least on the received measurements from the metabolic measurement device providing the direct metabolic measurements of the subject; determine an insulin attenuation factor, the determination of the insulin attenuation factor occurring after the assessing of the risk of hypoglycemia; provide one or more options as an output addressing the assessed risk of hypoglycemia in the subject, the output instructing the subject to: a) take no action; b) attenuate insulin delivery using the determined insulin attenuation factor; c) take additional intervention; or d) attenuate insulin delivery using the determined insulin attenuation factor and take additional intervention. ### Claim 11 (depends on 10) The non-transitory computer readable recording medium of claim 10, wherein: the one or more processors include a glucose meter, an insulin pump, an artificial pancreas, an insulin device, a personal computer, a PDA, a netbook, a laptop, and/or a cellular telephone. ### Claim 12 (depends on 10) The non-transitory computer readable recording medium of claim 10, wherein: the program causes the one or more processors to calculate the attenuation factor based on the assessed risk of hypoglycemia. ### Claim 13 (depends on 12) The non-transitory computer readable recording medium of claim 12, wherein: the program causes the one or more processors to implement a safety supervision function that calculates the attenuation factor. ### Claim 14 (depends on 10) The non-transitory computer readable recording medium of claim 10, wherein: the program causes the one or more processors to evaluate a risk of hypoglycemia based on the assessed risk of hypoglycemia.