# US 9,750,438 B2 · CGM-based prevention of hypoglycemia via hypoglycemia risk assessment and smooth reduction of insulin delivery > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 9,750,438 B2 - Document ID: US9750438B2 - Status: Granted - Kind: B2 - Application number: 14/015,831 - Filed: 2013-08-30 - Published: 2014-02-13 - Granted: 2017-09-05 - 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/US9750438B2 ## 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 computer-implemented method for preventing or mitigating hypoglycemia in a patient, comprising: receiving by a processor continuous metabolic measurements associated with the subject from a metabolic measurement device continuously making direct metabolic measurements; continuously assessing by a processor a risk of hypoglycemia based on the received metabolic measurements; evaluating by a processor risk of hypoglycemia based on the assessed risk of hypoglycemia; and outputting to an output device a result of said evaluation, selected from one of: a) no action being needed; b) attenuation of insulin delivery being needed; c) additional patient intervention being needed; and d) attenuation of insulin delivery and additional patient intervention being needed. ### Claim 2 A computer-implemented method for preventing or mitigating hypoglycemia in a subject, comprising: receiving by a processor continuous metabolic measurements associated with the subject from a metabolic measurement device continuously making direct metabolic measurements; assessing by a processor a risk of hypoglycemia based on the received metabolic measurements; evaluating by a processor the risk of hypoglycemia based on the assessed risk of hypoglycemia; and outputting an alarm when the risk of hypoglycemia exceeds a predetermined threshold. ### Claim 3 A computer-implemented method for preventing or mitigating hypoglycemia in a subject, comprising: receiving continuous metabolic measurements associated with the subject from a metabolic measurement device continuously making direct metabolic measurements; assessing a risk of hypoglycemia based on the received metabolic measurements; evaluating the risk of hypoglycemia based on the assessed risk of hypoglycemia; providing a shut-down signal to an insulin pump to cease delivery of insulin to said subject for a predetermined time, upon evaluation of risk of hypoglycemia exceeding a predetermined threshold; outputting an alarm alerting the subject that risk of hypoglycemia exceeds said predetermined threshold; and enabling the subject to override said shut-down signal and continue delivery of insulin to said subject from said insulin pump. ### Claim 4 A computer-implemented method for preventing or mitigating hypoglycemia in a subject, comprising: receiving, by a processor, metabolic measurements associated with the subject from a metabolic measurement device continuously making direct metabolic measurements; assessing, by a processor, a risk of hypoglycemia based on the received metabolic measurements; and outputting to an output device a result of said evaluation, wherein the result is one of: a) no action being needed; b) attenuation of insulin being needed; c) subject intervention being needed; and d) attenuation of insulin and subject intervention being needed.