System and method for titrating basal insulin doses
AssigneeDexCom, Inc.
InventorsStephen D. Patek, Matthew S. Gerber, Enrique Campos-Nanez, Thibault Gautier, Leah Ziegler
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Abstract
A continuous glucose monitor (CGM)-driven basal insulin titration system and method for patients with Type 2 Diabetes can be adapted to the needs and concerns of subjects just starting on basal insulin therapy. The method uses as inputs historical CGM data, basal insulin dose information, reports of hypoglycemia, and past recommendations and generates an adjusted insulin dose along with a report advising whether to continue the titration process, or to stop. The method can generate a new recommendation on a regular basis (e.g., each day) until it determines an adequate, consistent dose size.
Claims34
A basal titration adjustment device for titrating a basal insulin dose for a subject, comprising:
- one or more processors;
- a continuous glucose monitor (CGM) module that, when executed by the one or more processors, receives CGM data obtained over at least a series of days and generates historical estimated glucose values (EGVs) therefrom and further generates from the EGVs values for each of a plurality of daily blood glucose state parameters each reflective of an aspect of a blood glucose state of the subject;
- an insulin module that, when executed by the one or more processors, receives daily basal insulin dose values administered to the subject over the series of days and generates therefrom daily effective doses that each represent a total plasma insulin serving the subject for that respective day and account for an accumulation of insulin in the subject from all previously administered doses;
- at least a first dose-daily blood glucose state response modeler that, when executed by the one or more processors, receives a first of the plurality of daily blood glucose state parameters and the daily effective doses and generates therefrom a first regularized dose-response model relating the first daily blood glucose state parameter to an effective basal insulin dose;
- a target dose adjuster that, when executed by the one or more processors, receives the first regularized dose-response model and generates therefrom a target basal insulin dose that is to produce a value of the first daily blood glucose state parameter that is predicted by the first regularized dose-response model with at least a specified confidence level;
- and
- a dose finalizer that, when executed by the one or more processors, receives the target basal insulin dose and values of one or more of the daily blood glucose state parameters and produces therefrom an adjusted basal insulin dose that modifies the target basal insulin dose in conformance with one or more pre-established safety rules.
A method for titrating a basal insulin dose for a subject, comprising:
- receiving CGM data obtained over at least a series of days and generating historical estimated glucose values (EGVs) therefrom;
- generating from the EGVs values for each of a plurality of blood glucose state parameters each reflective of an aspect of a blood glucose state of the subject;
- receiving basal insulin dose values administered to the subject over the series of days and generates therefrom effective doses that each represent a total plasma insulin serving the subject for that respective day and account for an accumulation of insulin in the subject from all previously administered doses;
- receiving a first of the plurality of blood glucose state parameters and the effective doses and generating therefrom a first regularized dose-response model relating the first blood glucose state parameter to an effective basal insulin dose;
- receiving the first regularized dose-response model and generating therefrom a target basal insulin dose that is to produce a value of the first blood glucose state parameter that is predicted by the first regularized dose-response model with at least a specified confidence level;
- and
- receiving the target basal insulin dose and values of one or more of the plurality of blood glucose state parameters and producing therefrom an adjusted basal insulin dose that modifies the target basal insulin dose in conformance with one or more pre-established safety rules.
Dependencies are inferred from the claim text.