US 12,226,458 B2
System for providing an up-to-date and long-acting or ultra-long-acting insulin dose guidance recommendation to treat diabetes mellitus
Alan John Michelich, Seattle, WA (US); Thomas Dedenroth Miller, Seattle, WA (US); Oleksandr Shvets, Everett, WA (US); Anuar Imanbayev, Seattle, WA (US); and Brad Warren Van Orden, Seattle, WA (US)
Assigned to Novo Nordisk A/S, Bagsvaerd (DK)
Filed by Novo Nordisk A/S, Bagsvaerd (DK)
Filed on May 20, 2019, as Appl. No. 16/417,032.
Application 16/417,032 is a continuation of application No. 16/020,478, filed on Jun. 27, 2018, granted, now 10,335,464.
Claims priority of provisional application 62/690,157, filed on Jun. 26, 2018.
Prior Publication US 2019/0388512 A1, Dec. 26, 2019
Int. Cl. A61K 38/28 (2006.01); A61B 5/00 (2006.01); A61B 5/145 (2006.01); A61K 38/26 (2006.01); A61P 3/10 (2006.01); G16H 10/60 (2018.01); G16H 20/17 (2018.01)
CPC A61K 38/28 (2013.01) [A61B 5/14532 (2013.01); A61B 5/4839 (2013.01); A61P 3/10 (2018.01); G16H 20/17 (2018.01); A61K 38/26 (2013.01); A61K 2300/00 (2013.01); G16H 10/60 (2018.01)] 29 Claims
 
1. A system for providing a long-acting or ultra-long-acting insulin dose guidance recommendation for a subject to treat diabetes mellitus, wherein the system comprises one or more processors and a memory, the memory comprising:
instructions that, when executed by the one or more processors, perform a method responsive to receiving a dose guidance request (DGR) comprising determining whether or not to autonomously adjust a dosage recommendation based on the DGR, said instructions comprising:
(A) obtaining a first data structure that comprises at least:
(i) an upper limit target glucose range (UTR) of the subject, and (ii) a lower limit target glucose range (LTR) of the subject;
(B) obtaining a second data structure, comprising:
(i) a current dose guidance baseline (DGB), and (ii) a corresponding DGB timestamp representing when the DGB was made,
wherein the current DGB corresponds to:
(a) a most recent adjustment day dose recommendation (ADDR), and/or
(b) a starting basal dose (SBD);
(C) obtaining a first data set, comprising a plurality of glucose measurements of the subject taken over a time course and thereby establishing a blood glucose history (BGH), each respective glucose measurement in the plurality of glucose measurements comprising:
(i) a blood glucose (BG) level, and
(ii) a corresponding glucose timestamp (BGT) representing when in the time course the respective glucose measurement was made;
(D) obtaining a second data set, comprising a basal insulin injection history (IH) of the subject, wherein the injection history comprises a plurality of injections during all or a portion of the time course and, for each respective injection in the plurality of injections comprising:
(i) a corresponding injection amount (IA),
(ii) an injection timestamp (IT) representing when in the time course the respective injection occurred;
(E) obtaining a third data structure, comprising:
an injection data refresh timestamp (IDR) of the subject,;
(F) evaluating at least the first data structure, the second data structure, the third data structure, the first data set, and the second data set and thereby determining whether they collectively contain a set of evaluation information comprising at least:
(i) the glucose upper and lower target range levels of the subject,
(ii) the current dose guidance baseline and the corresponding timestamp,
(iii) the injection history refresh timestamp for the subject,
(iv) the plurality of glucose measurements of the subject taken over the time course, and
(v) the injection history of the subject;
wherein:
when a determination is made that the at least first data structure, second data structure, third data structure, first data set, and second data set collectively do contain the set of evaluation information, and when the dose guidance request was received within a given time limit from the injection data refresh timestamp, then the method further comprises providing the long-acting or ultra-long-acting insulin ADDR, the recommendation being calculated based on data from the first data structure, the second data structure, the first data set, and second data set, and further comprises autonomously adjusting a dosage recommendation configured to be provided to a patient based on the ADDR;
when a determination is made that the first data structure, the second data structure, the third data structure, the first data set, and the second data set fail to collectively contain the set of evaluation information, or when the dose guidance request was received after the given time limit from the injection history refresh timestamp, then no long-acting or ultra-long-acting insulin ADDR is provided and the dosage recommendation configured to be provided to the patient is not autonomously adjusted.