Patent
Method and system for the safety, analysis and supervision of insulin pump action and other modes of insulin delivery in diabetes
| العنوان: | Method and system for the safety, analysis and supervision of insulin pump action and other modes of insulin delivery in diabetes |
|---|---|
| Patent Number: | 11069,434 |
| تاريخ النشر: | July 20, 2021 |
| Appl. No: | 13/634040 |
| Application Filed: | March 11, 2011 |
| مستخلص: | An insulin delivery supervisor (IDS) with a safety analysis and supervision function that can reside between the insulin request and the insulin delivery and can intercept any excessive insulin requests before the insulin was delivered. The IDS can be implemented in any system based on insulin pump or pen and will work with either SMBG or CGM modes of blood glucose monitoring. |
| Inventors: | Breton, Marc D. (Charlottesville, VA, US); Patek, Stephen D. (Charlottesville, VA, US); Kovatchev, Boris P. (Charlottesville, VA, US); Hughes, Colleen S. (Charlottesville, VA, US) |
| Assignees: | UNIVERSITY OF VIRGINIA PATENT FOUNDATION (Charlottesville, VA, US) |
| Claim: | 1. A method for detecting and correcting for an excessive insulin request, the method comprising: detecting and intercepting, by an insulin delivery supervisor, a signal requesting delivery to a patient of an amount of insulin, u(t), by an insulin delivery device, prior to said signal being sent to said insulin delivery device; in response to detection of said insulin delivery request signal, determining, by said insulin delivery supervisor, whether delivery of u(t) will result in hypoglycemia in said patient, said determination involving: when SMBG at time t is available: computing a projected blood glucose concentration, BG proj (t) of said patient, wherein: [mathematical expression included] SMBG(t) is a self-monitoring BG assessment at time t, AI pump (t) is active insulin at time t, CF is a self-assessed correction factor of said patient, given in mg/dlU, and 60/k is a control update interval of insulin data in minutes; computing an amount of carbohydrates (g) that are required to maintain a target blood glucose concentration, BG target , given u(t), wherein: [mathematical expression included] and Û correction (t) is an estimate of an amount of insulin necessary to account for a positive deviation from BG target ; computing an amount of carbohydrates, M(t), required to maintain BG target if u(t) is delivered in full, wherein: [mathematical expression included] is the control update interval of insulin data in minutes, and CR is a self-assessed carbohydrate ratio, given in gCHO/U; classifying said insulin delivery request signal as an excessive insulin request when BG proj (t) |
| Claim: | 2. The method of claim 1 , wherein SMBG at time t is not available includes an SMBG not being available during any time τ prior to and including time t. |
| Claim: | 3. The method of claim 1 , wherein when SMBG at time t is available: generating a signal to consume said computed amount of carbohydrates M(t) as opposed to generating an updated u(t), and using said un-updated u(t) by said insulin delivery device to deliver insulin to said patient, wherein [mathematical expression included] |
| Claim: | 4. The method according to claim 1 , wherein when SMBG at time t is not available: generating a signal to consume said computed amount of carbohydrates M(t) as opposed to generating an updated u(t), and using said un-updated u(t) by said insulin delivery device to deliver insulin to said patient, wherein [mathematical expression included] |
| Claim: | 5. The method according to claim 3 , comprising: receiving, by the insulin delivery supervisor, a signal that said computed amount of carbohydrates M(t) has been consumed. |
| Claim: | 6. The method according to claim 4 , comprising: receiving, by the insulin delivery supervisor, a signal that said computed amount of carbohydrates M(t) has been consumed. |
| Claim: | 7. A system for detecting and correcting for an excessive insulin request, comprising: an insulin delivery device configured to deliver an amount of insulin to a diabetic patient in response to a request signal; and a safety supervision module configured to: detect and intercept a signal requesting delivery to said patient of an amount of insulin, u(t), by said insulin delivery device, prior to said signal being sent to said insulin delivery device; in response to detection of said insulin delivery request signal, determine whether delivery of u(t) will result in hypoglycemia in said patient, said determination involving: when SMBG at time t is available: computing a projected blood glucose concentration, BG proj (t), of said patient, wherein: [mathematical expression included] SMBG(t) is a self-monitoring BG assessment at time t, AI pump (t) is active insulin at time t, CF is a self-assessed correction factor of said patient, given in mg/dlU, and [mathematical expression included] is a control update interval of insulin data in minutes; computing an amount of carbohydrates (g) that are required to maintain a target blood glucose concentration, BG target , given u(t), wherein: [mathematical expression included] and Û correction (t) is an estimate of an amount of insulin necessary to account for a positive deviation from BG target ; computing an amount of carbohydrates, M(t), required to maintain BG target if u(t) is delivered in full, wherein: [mathematical expression included] is the control update interval of insulin data in minutes, and CR is a self-assessed carbohydrate ratio, given in gCHO/U; classifying said insulin delivery request signal as an excessive insulin request when BG proj (t) |
| Claim: | 8. The system of claim 7 , wherein SMBG at time t is not available includes an SMBG not being available during any time τ prior to and including time t. |
| Claim: | 9. The system of claim 7 , wherein when SMBG at time t is available: said safety supervision module generates a signal to consume said computed amount of carbohydrates M(t) as opposed to generating an updated u(t), wherein said insulin delivery device uses said un-updated u(t) to deliver insulin to said patient, wherein [mathematical expression included] |
| Claim: | 10. The system of claim 7 , wherein when SMBG at time t is not available: said safety supervision module generates a signal to consume said computed amount of carbohydrates M(t) as opposed to generating an updated u(t), wherein said insulin delivery device uses said un-updated u(t) to deliver insulin to said patient, wherein [mathematical expression included] |
| Claim: | 11. The system of claim 9 , wherein said safety supervision module is configured to receive a signal that said computed amount of carbohydrates M(t) has been consumed. |
| Claim: | 12. The system of claim 10 , wherein said safety supervision module is configured to receive a signal that said computed amount of carbohydrates M(t) has been consumed. |
| Claim: | 13. A non-transitory computer readable medium having stored thereon computer executable instructions for detecting and correcting for an excessive insulin request that when executed cause at least one processor to: detect and intercept, by an insulin delivery supervisor, a signal requesting delivery to a diabetic patient of an amount of insulin, u(t), by an insulin delivery device, prior to said signal being sent to said insulin delivery device; in response to detection of said insulin delivery request signal, determine, by said insulin delivery supervisor, whether delivery of u(t) will result in hypoglycemia in said patient, said determination involving: when SMBG at time t is available: computing a projected blood glucose concentration, BG proj (t), of said patient, wherein: [mathematical expression included] SMBG(t) is a self-monitoring BG assessment at time t, AI pump (t) is active insulin at time t, CF is a self-assessed correction factor of said patient, given in mg/dlU, and [mathematical expression included] is a control update interval of insulin data in minutes; computing an amount of carbohydrates (g) that are required to maintain a target blood glucose concentration, BG target , given u(t), wherein: [mathematical expression included] and Û correction (t) is an estimate of an amount of insulin necessary to account for a positive deviation from BG target ; computing an amount of carbohydrates, M(t), required to maintain BG target if u(t) is delivered in full, wherein: [mathematical expression included] is the control update interval of insulin data in minutes, and CR is a self-assessed carbohydrate ratio, given in gCHO/U; classifying said insulin delivery request signal as an excessive insulin request when BG proj (t) |
| Claim: | 14. The non-transitory computer readable medium of claim 13 , wherein SMBG at time t is not available includes an SMBG not being available during any time τ prior to and including time t. |
| Claim: | 15. The non-transitory computer readable medium of claim 13 , wherein when SMBG at time t is available: generating, via said insulin delivery supervisor, a signal to consume said computed amount of carbohydrates M(t) as opposed to generating an updated u(t), and using said un-updated u(t) by said insulin delivery device to deliver insulin to said patient, wherein [mathematical expression included] |
| Claim: | 16. The non-transitory computer readable medium of claim 13 , wherein when SMBG at time t is not available: generating, via said insulin delivery supervisor, a signal to consume said computed amount of carbohydrates M(t) as opposed to generating an updated u(t), and using said un-updated u(t) by said insulin delivery device to deliver insulin to said patient, wherein [mathematical expression included] |
| Claim: | 17. The non-transitory computer readable medium of claim 15 , wherein the insulin delivery supervisor receives a signal that said computed amount of carbohydrates M(t) has been consumed. |
| Claim: | 18. The non-transitory computer readable medium of claim 16 , wherein the insulin delivery supervisor receives a signal that said computed amount of carbohydrates M(t) has been consumed. |
| Claim: | 19. The system of claim 7 , comprising: a user interface configured to transmit signals between said safety supervision module and said patient. |
| Patent References Cited: | 6024090 February 2000 Gonda et al. 2006/0094947 May 2006 Kovatchev et al. 2008/0199894 August 2008 Galasso 2008/0314395 December 2008 Kovatchev et al. 2009/0164239 June 2009 Hayter 2009/0234213 September 2009 Hayes et al. 2009/0281519 November 2009 Rao et al. 2011/0029269 February 2011 Hayter 2013/0116649 May 2013 Breton et al. 2545185 January 2013 2011112974 September 2011 |
| Other References: | Zisser et al. Bolus calculator: a Review of Four Smart Insulin Pumps. Diabetes Technology and Therapeutics (2008) vol. 10 No. 6 p. 441-447. (Year: 2008). cited by examiner Andreassen et al. a probabilistic approach to glucose prediction and insulin dose adjustment: description of metabolic model and pilot evaluation study. Computer methods and programs in biomedicine, 1994, vol. 41, pp. 153-165. (Year: 1994). cited by examiner Kovatchev et al., “Control to Range for Diabetes: Functionality and Modular Architecture,” Journal of Diabetes Science and Technology, vol. 3, Issue 5, Sep. 2009, pp. 1058-1065. cited by applicant Office Action dated Dec. 13, 2018, issued by the Canadian Intellectual Property Office in CA 2,792,758. cited by applicant Office Action dated Sep. 25, 2019, by the Canadian Patent Office in corresponding Canadian Patent Application No. 2,792,758. (3 pages). cited by applicant |
| Primary Examiner: | Zeman, Mary K |
| Attorney, Agent or Firm: | Buchanan Ingersoll & Rooney PC |
| رقم الانضمام: | edspgr.11069434 |
| قاعدة البيانات: | USPTO Patent Grants |
| الوصف غير متاح. |