US 12,266,436 B2
Method and system for the safety, analysis and supervision of insulin pump action and other modes of insulin delivery in diabetes
Marc D. Breton, Charlottesville, VA (US); Stephen D. Patek, Charlottesville, VA (US); Boris P. Kovatchev, Charlottesville, VA (US); and Colleen H. Karvetski, Charlottesville, VA (US)
Assigned to UNIVERSITY OF VIRGINIA PATENT FOUNDATION, Charlottesville, VA (US)
Filed by UNIVERSITY OF VIRGINIA PATENT FOUNDATION, Charlottesville, VA (US)
Filed on Jun. 4, 2021, as Appl. No. 17/339,153.
Application 17/339,153 is a continuation of application No. 13/634,040, granted, now 11,069,434, issued on Jul. 20, 2021, previously published as PCT/US2011/028163, filed on Mar. 11, 2011.
Claims priority of provisional application 61/312,916, filed on Mar. 11, 2010.
Prior Publication US 2021/0313036 A1, Oct. 7, 2021
This patent is subject to a terminal disclaimer.
Int. Cl. G16H 20/17 (2018.01); A61M 5/168 (2006.01); G01N 33/74 (2006.01)
CPC G16H 20/17 (2018.01) [A61M 5/16836 (2013.01); A61M 5/1684 (2013.01); G01N 33/74 (2013.01); G01N 2333/62 (2013.01); G01N 2800/042 (2013.01)] 20 Claims
 
1. A method for detecting and correcting for an excessive insulin request, the method comprising:
intercepting a signal requesting delivery to a patient of an amount of insulin at time t, u(t), wherein u(t) is based on a target blood glucose concentration, the intercepting occurring prior to the signal being received by an insulin delivery device;
determining that delivery of u(t) to the patient will result in hypoglycemia in the patient, the determining involving:
when self-monitoring BG assessment (SMBG) at time t, SMBG(t), is available:
calculating a projected blood glucose concentration of the patient based on SMBG(t);
calculating an amount of carbohydrates that is required to maintain the target blood glucose concentration for u(t); and
classifying the insulin delivery request signal as an excessive insulin request when the calculated projected blood glucose concentration is less than a blood glucose concentration threshold and when the calculated amount of carbohydrates that is required to maintain the target blood glucose concentration for u(t) is greater than a carbohydrate amount threshold:
when SMBG(t) is not available:
estimating an amount of carbohydrates that is required to maintain the target blood glucose concentration for u(t):
classifying the insulin delivery request signal as an excessive insulin request when the estimated amount of carbohydrates that is required to maintain the target blood glucose concentration for u(t) is greater than a carbohydrate amount threshold:
requesting SMBG(t) when the insulin delivery request signal is classified as an excessive insulin request:
upon receiving the SMBG(t):
calculating a projected blood glucose concentration of the patient based on SMBG(t);
calculating an amount of carbohydrates that is required to maintain the target blood glucose concentration for u(t); and
classifying the insulin delivery request signal as an excessive insulin request when the calculated projected blood glucose concentration is less than a blood glucose concentration threshold and when the calculated amount of carbohydrates that is required to maintain the target blood glucose concentration for u(t) is greater than a carbohydrate amount threshold;
when the insulin delivery request signal is classified as an excessive insulin request, generating an updated u(t) based on a blood glucose concentration threshold as opposed to the target blood glucose concentration for u(t); and
transmitting the updated u(t) to the insulin delivery device.