# US 11,027,063 B2 · Insulin delivery methods, systems and devices > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,027,063 B2 - Document ID: US11027063B2 - Status: Granted - Kind: B2 - Application number: 15/870,703 - Filed: 2018-01-12 - Published: 2018-07-19 - Granted: 2021-06-08 - Earliest claimed: 2017-01-13 - Assignees: Bigfoot Biomedical, Inc. - Applicants: Bigfoot Biomedical, Inc. - Inventors: Bryan Mazlish; Lane Desborough - Web page: https://patentgrep.com/patent/US11027063B2 ## CPC - A61M 5/1723: {using feedback of body parameters, e.g. blood sugar or pressure} - A61B 5/14532: {for measuring glucose, e.g. by tissue impedance measurement} - A61M 5/14248: {of the skin patch type} - G16H 20/17: delivered via infusion or injection - G16H 40/63: for local operation - A61B 5/4839: {combined with drug delivery} - A61K 38/28: Insulins - A61M 5/003: {Kits for diabetics} - A61M 5/31568: {Means keeping track of the total dose administered, e.g. since the cartridge was inserted} - A61M 2205/35: Communication - A61M 2205/502: User interfaces, e.g. screens or keyboards - A61M 2205/52: with memories providing a history of measured variating parameters of apparatus or patient - A61M 2230/201: Glucose concentration - 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)} - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) ## Abstract An insulin delivery monitoring system that includes an insulin delivery device and a controller configured to perform or control performance of operations. A method of insulin delivery include determining a correction dose of insulin and triggering an alert. ## Claims ### Claim 1 An insulin delivery monitoring system comprising: an insulin delivery device configured to deliver insulin to a user; and a controller configured to perform or control performance of operations, the operations comprising: receiving notification of an amount of insulin delivered by the insulin delivery device; determining a correction dose; comparing the correction dose with a threshold insulin delivery amount; and when the correction dose exceeds the threshold insulin delivery amount, triggering an alert to the user. ### Claim 2 (depends on 1) The insulin delivery monitoring system of claim 1, wherein the controller is configured to base the correction dose on at least one of (1) a variance between an estimated blood glucose level of the user and a target blood glucose level of the user, (2) an insulin sensitivity factor of the user, or (3) an amount of insulin on board for the user, the insulin on board for the user based at least on the amount of insulin delivered by the insulin delivery device. ### Claim 3 (depends on 2) The insulin delivery monitoring system of any of claim 2, further comprising a blood glucose monitoring device, the blood glucose monitoring device configured to detect the blood glucose level of the user and provide the blood glucose level to the controller, the estimated blood glucose level based on the blood glucose level. ### Claim 4 (depends on 1) The insulin delivery monitoring system of claim 1, wherein the system is configured to base the threshold insulin delivery amount on an average total amount of daily basal insulin delivered to the user or a nominal basal rate for the user. ### Claim 5 (depends on 1) The insulin delivery monitoring system of claim 1, wherein the system is configured to base the threshold insulin delivery amount on an estimate of an amount of insulin that would typically be administered to a user as basal insulin over a period of time between 1 hour and 3 hours. ### Claim 6 (depends on 1) The insulin delivery monitoring system of claim 1, wherein the system is configured to include a static amount of insulin in the threshold insulin delivery amount. ### Claim 7 (depends on 1) The insulin delivery monitoring system of claim 1, wherein the system is configured to include an amount of basal insulin delivered during a diurnal time period based on a personalized delivery schedule in the threshold insulin delivery amount. ### Claim 8 (depends on 7) The insulin delivery monitoring system of claim 7, wherein the system is configured to include at least one delivery action at an amount greater than a baseline basal rate in the personalized delivery schedule. ### Claim 9 (depends on 1) The insulin delivery monitoring system of claim 1, wherein the system is configured to base the correction dose on an equation including: E ⁢ ⁢ G ⁢ ⁢ V - Target I ⁢ ⁢ S ⁢ ⁢ F - I ⁢ ⁢ O ⁢ ⁢ B ### Claim 10 An insulin delivery monitoring system comprising: an insulin delivery device configured to deliver insulin to a user; a blood glucose monitoring device, the blood glucose monitoring device configured to detect a blood glucose level of the user; and a controller configured to perform or control performance of operations, the operations comprising: receiving the blood glucose level from the blood glucose monitoring device; determining a correction dose of insulin; comparing the correction dose with a threshold insulin delivery amount; and when the correction dose exceeds the threshold insulin delivery amount, triggering an alert to the user. ### Claim 11 (depends on 10) The insulin delivery monitoring system of claim 10, wherein the operations of the controller further comprise estimating a future blood glucose level. ### Claim 12 A method of insulin delivery monitoring, the method comprising: receiving notification of an amount of insulin delivered by an insulin delivery device configured to deliver insulin to a user; determining a correction dose of insulin with a controller in communication with a blood glucose level; comparing the correction dose with a threshold insulin delivery amount with the controller; and when the correction dose exceeds the threshold insulin delivery amount, triggering an alert to the user with the controller. ### Claim 13 (depends on 12) The method of claim 12, further comprising receiving a blood glucose level of a user from a blood glucose monitoring device. ### Claim 14 (depends on 12) The method of claim 12, further comprising basing the correction dose on at least one of a variance between an estimated blood glucose level of the user and a target blood glucose level of the user, an insulin sensitivity factor of the user, or an amount of insulin on board for the user, the insulin on board for the user based at least on the amount of insulin delivered by the insulin delivery device. ### Claim 15 (depends on 12) The method of claim 12, further comprising enabling the user to customize the alert. ### Claim 16 (depends on 15) The method of claim 15, wherein enabling the user to customize the alert comprises receiving a value relating to the threshold insulin delivery amount with the controller. ### Claim 17 (depends on 15) The method of claim 15, wherein enabling the user to customize the alert comprises providing a factor relating to the sensitivity of an alarm. ### Claim 18 (depends on 12) The method of claim 12, further comprising alerting the user that the correction dose of insulin is recommended. ### Claim 19 (depends on 18) The method of claim 18, further comprising only determining the corrective dose when the user requests the corrective dose. ### Claim 20 (depends on 12) The method of claim 12, further comprising basing the threshold insulin delivery amount on an average total amount of daily basal insulin delivered to the user or a nominal basal rate for the user.