Techniques for determining automated insulin delivery dosages

Inventors

Lee, Joon Bok • Zheng, Yibin • CARDINALI, Steven • O'Connor, Jason

Assignees

Insulet Corp

Abstract

Methods and apparatuses for performing an insulin infusion process are described. For example, an apparatus may include at least one memory and logic coupled to the at least one memory. The logic may operate to determine a basal parameter for a patient based on a type 2 diabetes (T2D) multiple daily injection (MDI) information of the patient, the basal parameter indicating a basal infusion rate, determine an additional insulin (Iadd) value based on a mean blood glucose difference (BGdiff) information associated with the patient, determine an insulin volume to infuse into the patient based on the basal parameter and Iadd, and administer the insulin volume to the patient. Other embodiments are described.

Core Innovation

The invention describes an automated insulin delivery (AID) approach tailored to type 2 diabetes (T2D) that uses type 2 diabetes multiple daily injection (MDI) information to determine a basal parameter indicating a basal infusion rate. The MDI information includes a multiple daily injection therapy specification describing a plurality of manual injections to be administered to a patient on a daily basis. Based on these inputs, the logic determines an insulin infusion process that includes both basal infusion rate determination and an additional insulin component.

The invention further determines an additional insulin (Iadd) value based on mean blood glucose difference (BGdiff) information associated with the patient. The BGdiff information is determined from a difference between a current glycated hemoglobin (A1Ccurrent) level and a target glycated hemoglobin (A1Ctarget) level for the patient. The additional insulin value Iadd is determined according to Iadd=BGdiff*CF*x, where x is a tunable cycle parameter configured to represent a number of cycles of insulin peak times per an infusion time period and CF is a correction factor.

The invention computes an insulin volume to infuse into the patient based on the basal parameter and the additional insulin (Iadd) value and administers the insulin volume using an AID device. The description further outlines safety constraint mechanisms, including maximum additional insulin delivery, duration maximum/integral limits, and insulin-on-board (IOB) constraints with IOB decay, in which safety constraint adjustment logic limits or adjusts insulin delivery and can include binary delivery limiting vs basal fallback.

Claims Coverage

The patent includes two independent claims: an apparatus claim and a method claim. Both share the same core inventive structure of determining a basal parameter from T2D MDI information, determining additional insulin (Iadd) from mean blood glucose difference (BGdiff) derived from A1Ccurrent and A1Ctarget, computing Iadd using a tunable cycle parameter and correction factor, and administering an insulin volume via an AID device.

Across both independent claims, the inventive coverage is directed to computing a basal infusion rate parameter from T2D MDI therapy specification, deriving BGdiff from the difference between A1Ccurrent and A1Ctarget, calculating Iadd via Iadd=BGdiff*CF*x with x as a tunable cycle parameter and CF as a correction factor, and then using those results to determine an insulin volume for administration through an AID device.

Stated Advantages

Documented Applications