Systems and methods for incorporating co-formulations of insulin in an automatic insulin delivery system

Inventors

Lee, Joon Bok • O'Connor, Jason • Zheng, Yibin • ZADE, Ashutosh

Assignees

Insulet Corp

Abstract

Disclosed herein are systems and methods for the delivery of a co-formulation of insulin and a second drug, such as GLP-1, using an automated insulin delivery system. In a first embodiment, a dose of insulin is calculated by a medication delivery algorithm and a reduction factor is applied to account for the effect of second drug on the user's daily insulin requirement. In a second embodiment of the invention, a total amount of the second drug administered to the user during the past 24 hours is used to modify the correction factor and the insulin-to-carbohydrate ratio used by the medication delivery algorithm to cause a reduction in the insulin delivered to the user to account for the effect of the administration of the second drug portion of the co-formulation.

Core Innovation

An automated insulin delivery system calculates a dose of insulin to be delivered to a user using a controller. The system calculates a reduction factor configured to reduce the amount of insulin to be delivered to compensate for the effect of a quantity of GLP-1 or pramlintide previously delivered, and applies the adjustment factor to obtain an adjusted dose having a reduced amount of insulin that accounts for the user's reduced need for insulin.

The disclosed approach constrains the prior delivery context to a most recent predetermined time period. In embodiments reflected in the dependent claims, the system uses an insulin-to-carbohydrate ratio to obtain an adjusted insulin dose with a reduced amount of insulin, determines a modified insulin-to-carbohydrate ratio based on the quantity of GLP-1 delivered, and calculates the delivered insulin dose using the modified ratio.

In further embodiments, the modified insulin-to-carbohydrate ratio or the reduction factor is determined based on effects modeled at the population level. The system calculates the modified ratio using an average effect of GLP-1 delivery in a co-formulation on insulin sensitivity of a population of users, determines the reduction factor based on an average reduction in daily insulin need across a population of users, and includes embodiments where GLP-1 is delivered as a co-formulation of GLP-1 and insulin with the reduction factor determined from the concentration of GLP-1 in the co-formulation.

Claims Coverage

The partial content identifies three independent claim sets that share a common inventive concept based on calculating an insulin reduction factor to compensate for the effect of previously delivered GLP-1 or pramlintide. The claims include inventive features related to the reduction factor, application of an adjustment factor to obtain an adjusted reduced insulin dose, and delivery via a drug delivery device, with dependent claim refinements that constrain timing and define modeling mechanisms.

Across the independent claims identified in the partial content, the shared inventive concept is to compute a reduction factor to compensate for effects of previously delivered GLP-1 or pramlintide, apply an adjustment factor to obtain an adjusted reduced insulin dose, and deliver the adjusted dose with a drug delivery device. Dependent claim refinements constrain the previously delivered quantity to a most recent predetermined time period and specify modeling mechanisms such as modifying an insulin-to-carbohydrate ratio based on delivered GLP-1 quantity, computing effects using population-average insulin sensitivity or average reduction in daily insulin need, and determining the reduction factor from GLP-1 concentration in a GLP-1 plus insulin co-formulation.

Stated Advantages

Documented Applications