# US 10,500,334 B2 · System and method for adjusting insulin delivery > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,500,334 B2 - Document ID: US10500334B2 - Status: Granted - Kind: B2 - Application number: 15/870,666 - Filed: 2018-01-12 - Published: 2018-07-19 - Granted: 2019-12-10 - Earliest claimed: 2017-01-13 - Assignees: Bigfoot Biomedical, Inc. - Applicants: Bigfoot Biomedical, Inc. - Inventors: Bryan Mazlish; Lane Desborough; Ross Naylor - Web page: https://patentgrep.com/patent/US10500334B2 ## 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} - A61B 5/4839: {combined with drug delivery} - A61M 5/14248: {of the skin patch type} - A61M 5/31568: {Means keeping track of the total dose administered, e.g. since the cartridge was inserted} - G16H 20/17: delivered via infusion or injection - G16H 40/63: for local operation - A61K 38/28: Insulins - A61M 5/003: {Kits for diabetics} - A61M 2205/3379: Masses, volumes, levels of fluids in reservoirs, flow rates - A61M 2205/35: Communication - A61M 2205/3569: sublocal, e.g. between console and disposable - A61M 2205/3584: using modem, internet or Bluetooth® - 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 2205/8206: battery-operated - 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 The embodiments described herein may relate to methods and systems for adjusting insulin delivery. Some methods and systems may be configured to adjust insulin delivery to personalize automated insulin delivery for a person with diabetes. Some methods and systems may be configured to adjust insulin delivery to a person with diabetes according to one or more conditions of an insulin delivery device. Some methods and systems may be configured to enable a lock-out mode where adjustment to insulin delivery to personalize automated insulin delivery is restricted. ## Claims ### Claim 1 A system, comprising: an insulin delivery device configured to deliver insulin to a user of the insulin delivery device; and an insulin delivery control unit associated with the insulin delivery device, wherein the insulin delivery control unit is configured to: determining a shelf-life risk score for undelivered insulin within the insulin delivery device; and based on the shelf-life risk score exceeding a threshold, enabling a lock-out mode for locking out automated modification of a baseline basal insulin rate for the user of the insulin delivery device until the insulin delivery device has fresh insulin. ### Claim 2 (depends on 1) The system of claim 1, wherein the shelf-life risk score is at least based on an age of the undelivered insulin. ### Claim 3 (depends on 1) The system of claim 1, wherein determining a shelf-life risk score for undelivered insulin within the insulin delivery device comprises receiving a shelf-life risk score from a diabetes management system. ### Claim 4 (depends on 1) The system of claim 1, wherein the insulin delivery control unit controls the insulin delivery device to: deliver insulin at a first point in time according to a first insulin delivery action of a first series of insulin delivery actions of a first insulin delivery profile, the first series of insulin delivery actions including at least one action that includes delivering insulin at a rate larger than the baseline basal insulin rate; and deliver insulin at a second point in time according to a first insulin delivery action of a second series of insulin delivery actions of a second insulin delivery profile, the second series of insulin delivery actions including delivering insulin at the rate larger than the baseline basal insulin rate, wherein the shelf-life risk score is further based on a number of times insulin is delivered at the rate larger than the baseline basal insulin rate exceeding a threshold. ### Claim 5 (depends on 1) The system of claim 1, further comprising a diabetes management system associated with the insulin delivery device and configured to track undelivered insulin within the insulin delivery device. ### Claim 6 (depends on 5) The system of claim 5, wherein tracking undelivered insulin within the insulin delivery device comprises tracking an age of undelivered insulin. ### Claim 7 (depends on 5) The system of claim 5, wherein the diabetes management system associated with the insulin delivery device is configured to track insulin delivery actions of the insulin delivery device. ### Claim 8 (depends on 7) The system of claim 7, wherein the diabetes management system associated with the insulin delivery device is configured to determine a frequency of an insulin delivery action of the tracked insulin delivery actions, wherein the insulin delivery action comprises delivering a dose of insulin that exceeds a threshold. ### Claim 9 (depends on 8) The system of claim 8, wherein the threshold is a multiple or a fraction of the baseline basal insulin rate. ### Claim 10 A method comprising: determining a shelf-life risk score for undelivered insulin within an insulin delivery device; and based on the shelf-life risk score exceeding a threshold, locking out automated modification of a baseline basal insulin rate for a user of the insulin delivery device until the insulin delivery device has fresh insulin. ### Claim 11 (depends on 10) The method of claim 10, wherein the shelf-life risk score is at least based on an age of the undelivered insulin. ### Claim 12 (depends on 10) The method of claim 10, wherein determining the shelf-life risk score for undelivered insulin within the insulin delivery device comprises receiving a shelf-life risk score from a diabetes management system. ### Claim 13 (depends on 10) The method of claim 10, further comprising: delivering insulin at a first point in time according to a first insulin delivery action of a first series of insulin delivery actions of a first insulin delivery profile, the first series of insulin delivery actions including at least one action that includes delivering insulin at a rate larger than the baseline basal insulin rate; and delivering insulin at a second point in time according to a first insulin delivery action of a second series of insulin delivery actions of a second insulin delivery profile, the second series of insulin delivery actions including delivering insulin at the rate larger than the baseline basal insulin rate; wherein the shelf-life risk score is further based on a number of times insulin is delivered at the rate larger than the baseline basal insulin rate exceeding a threshold. ### Claim 14 (depends on 10) The method of claim 10, wherein locking out automated modification of a baseline basal insulin rate prevents modification of the baseline basal insulin rate upwards while allowing automated modification of the baseline basal insulin rate downwards. ### Claim 15 (depends on 10) The method of claim 10, further comprising generating a message that the shelf-life risk score has exceeded the threshold.