EP-4738376-A2 - SYSTEM AND METHOD FOR ADJUSTING INSULIN DELIVERY

EP4738376A2EP 4738376 A2EP4738376 A2EP 4738376A2EP-4738376-A2

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. Such personalization may include adjusting user specific dosage parameters in response to a user provided insulin delivery amount, including a user provided insulin delivery amount that varies from a recommended insulin delivery amount.

Inventors

MAZLISH, Bryan
DESBOROUGH, Lane
NAYLOR, ROSS

Assignees

Insulet Corporation

Dates

Publication Date: 20260506
Application Date: 20180112

Claims (12)

A method, comprising: receiving CGM data regarding a person with diabetes; detecting an unannounced meal based on changes in glucose values indicated by the CGM data; inferring an amount of carbohydrates from the unannounced meal based on the CGM data; and estimating unacted carbohydrates based on the inferred amount of carbohydrates from the unannounced meal.
The method of claim 1 wherein detecting the unannounced meal comprises determining that a change in glucose values exceeds a threshold, wherein the threshold is associated with an expected change in glucose values.
The method of claim 1, wherein estimating the unacted carbohydrates comprises using a Carbohydrates On Board calculation that is based on a decay function and the inferred amount of carbohydrates from the unannounced meal.
The method of claim 1, comprising: determining at least partially based on the estimated unacted carbohydrates, one or more user-specific dosage parameters for future insulin delivery.
The system of claim 1, comprising: determining, at least partially based on the estimated unacted carbohydrates, predictions of multiple glucose values for multiple different basal insulin delivery profiles or basal insulin delivery rates, and select one of the basal insulin delivery profiles or basal insulin delivery rates based on a determination of which of the multiple different basal insulin delivery profiles or basal insulin delivery rates will approximate a target glucose level.
The system of claim 1, comprising: determining, at least partially based on the estimated unacted carbohydrates, predictions of multiple glucose values for multiple different basal insulin delivery profiles or basal insulin delivery rates, and select one of the basal insulin delivery profiles or basal insulin delivery rates based on a determination of which of the multiple different basal insulin delivery profiles or basal insulin delivery rates will minimize a difference between a predicted glucose value and a target glucose value.
A system, comprising: an insulin delivery device configured to deliver insulin to the person with diabetes; a continuous glucose monitor configured to provide CGM data regarding the person with diabetes; and a control device in communication with the insulin delivery device and the continuous glucose monitor, the control device configured to: detect an unannounced meal based on changes in glucose values indicated by the CGM data; infer an amount of carbohydrates from the unannounced meal based on the CGM data; and estimate unacted carbohydrates based on the inferred amount of carbohydrates from the unannounced meal.
The system of claim 7 wherein the control device is configured to detect the unannounced meal by determining that a change in glucose values exceeds a threshold, wherein the threshold is associated with an expected change in glucose values.
The system of claim 7, wherein the control device is configured to estimate unacted carbohydrates using a Carbohydrates On Board calculation that is based on a decay function and the inferred amount of carbohydrates from the unannounced meal.
The system of claim 7, wherein the control device is configured to determine, at least partially based on the estimated unacted carbohydrates, one or more user-specific dosage parameters for future insulin delivery.
The system of claim 7, wherein the control device is configured to determine, at least partially based on the estimated unacted carbohydrates, predictions of multiple glucose values for multiple different basal insulin delivery profiles or basal insulin delivery rates, and select one of the basal insulin delivery profiles or basal insulin delivery rates based on a determination of which of the multiple different basal insulin delivery profiles or basal insulin delivery rates will approximate a target glucose level.
The system of claim 7, wherein the control device is configured to determine, at least partially based on the estimated unacted carbohydrates, predictions of multiple glucose values for multiple different basal insulin delivery profiles or basal insulin delivery rates, and select one of the basal insulin delivery profiles or basal insulin delivery rates based on a determination of which of the multiple different basal insulin delivery profiles or basal insulin delivery rates will minimize a difference between a predicted glucose value and a target glucose value.

Description

PRIORITY CLAIM This application claims the benefit under 35 U.S.C. §119(e) of U.S. Provisional Patent Application Serial No. 62/446,236, filed January 13, 2017, the disclosure of which is hereby incorporated herein in its entirety by this reference. TECHNICAL FIELD This document relates to systems and methods for adjusting insulin delivery. BACKGROUND Diabetes mellitus is a chronic metabolic disorder caused by an inability of a person's pancreas to produce sufficient amounts of the hormone, insulin, such that the person's metabolism is unable to provide for the proper absorption of sugar and starch. This failure leads to hyperglycemia, i.e., the presence of an excessive amount of glucose within the blood plasma. Persistent hyperglycemia has been associated with a variety of serious symptoms and life threatening long-term complications such as dehydration, ketoacidosis, diabetic coma, cardiovascular diseases, chronic renal failure, retinal damage and nerve damages with the risk of amputation of extremities. Because healing is not yet possible, a permanent therapy is necessary that provides constant glycemic control in order to constantly maintain the level of blood glucose within normal limits. Such glycemic control is achieved by regularly supplying external drugs to the body of the patient to thereby reduce the elevated levels of blood glucose. Historically, diabetes is treated with multiple, daily injections of rapid and long acting insulin via a hypodermic syringe. One or two injections per day of a long acting insulin is administered to provide a basal level of insulin and additional injections of a rapidly acting insulin is administered before or with each meal in an amount proportional to the size of the meal. Insulin therapy can also be administered using an insulin pump that provides periodic or continuous release of the rapidly acting insulin to provide for a basal level of insulin and larger doses of that same insulin at the time of meals. Insulin pumps allow for the delivery of insulin in a manner that bears greater similarity to the naturally occurring physiological processes and can be controlled to follow standard or individually modified protocols to give the patient better glycemic control. In some circumstances, an insulin pump device can store (via input from a clinician or a user) a number of settings (e.g., dosage parameters or other settings) that are customized by the physician for the particular user. People with diabetes, their caregivers, and their health care providers (HCPs) bear a great deal of cognitive burden in managing intensive medicine therapy. Delivering the correct amount of the medicine at the correct time is an extremely challenging endeavor. Such delivery requires the patient to make dosing determinations multiple times per day and also requires a combination of the patient and the HCP to recalibrate the therapeutic parameters of the therapy on an episodic time frame that varies from individual to individual, and within individuals based on age and/or behavior (e.g., change in exercise, change in diet). In light of the many deficiencies and problems associated with current systems and methods for maintaining proper glycemic control, enormous resources have been put into finding better solutions. A number of new technologies promise to mitigate some of the cognitive burden that intensive insulin therapy now requires. Developing workable solutions to the problem that are simple, safe, reliable and able to gain regulatory approval has, however, proved to be elusive. For years, researchers have contemplated coupling a continuous glucose monitoring system with an insulin delivery device to provide an "artificial pancreas" to assist people living with diabetes. Their efforts have yet to result in a commercial product. What has been needed is a system and method that provides a level of automatic control of drug delivery devices for improved medicine delivery and glycemic control that is simple, safe, and reliable in a real world setting. DISCLOSURE One or more embodiments of the present disclosure may include a method. The method may include receiving a user specified bolus dose of insulin that is different than a recommended bolus dose of insulin; determining a meal component of the user specified bolus dose of insulin; adjusting one or more user specific dosage parameters based on the determined meal component; determining a future blood glucose level for a time interval based on the adjusted one or more user specific dosage parameters; determining a basal insulin delivery for the time interval based on the determined future blood glucose level; and configuring an insulin delivery system to deliver insulin during the time interval according to the determined basal insulin delivery. Other embodiments of the present disclosure may include a system for insulin delivery. The system may include an insulin delivery device and a processing unit. The insulin delivery device may be