Method and system for the safety, analysis and supervision of insulin pump action and other modes of insulin delivery in diabetes

Patent metadata

Field	Value
Publication number	US-11069434-B2
Application number	US-201113634040-A
Country	US
Kind code	B2
Filing date	Mar 11, 2011
Priority date	Mar 11, 2010
Publication date	Jul 20, 2021
Grant date	Jul 20, 2021

Abstract

An insulin delivery supervisor (IDS) with a safety analysis and supervision function that can reside between the insulin request and the insulin delivery and can intercept any excessive insulin requests before the insulin was delivered. The IDS can be implemented in any system based on insulin pump or pen and will work with either SMBG or CGM modes of blood glucose monitoring.

First claim

What is claimed is:

1. A method for detecting and correcting for an excessive insulin request, the method comprising:
detecting and intercepting, by an insulin delivery supervisor, a signal requesting delivery to a patient of an amount of insulin, u(t), by an insulin delivery device, prior to said signal being sent to said insulin delivery device;
in response to detection of said insulin delivery request signal, determining, by said insulin delivery supervisor, whether delivery of u(t) will result in hypoglycemia in said patient, said determination involving:
when SMBG at time t is available:
computing a projected blood glucose concentration, BG proj (t) of said patient, wherein:

B
⁢

G
proj

⁡

(
t
)

=

SMBG
⁡

(
t
)

-

[

u
⁡

(
t
)

-

BR
⁡

(
t
)

k

+

AI
pump

⁡

(
t
)

]

⁢
CF

,

 SMBG(t) is a self-monitoring BG assessment at time t, AI pump (t) is active insulin at time t, CF is a self-assessed correction factor of said patient, given in mg/dlU, and 60/k is a control update interval of insulin data in minutes;
computing an amount of carbohydrates (g) that are required to maintain a target blood glucose concentration, BG target , given u(t), wherein:

U
^

correction

⁡

(
t
)

=

SMBG
⁡

(
t
)

-

BG
target

CF

-

AI
pump

⁡

(
t
)

,

 and Û correction (t) is an estimate of an amount of insulin necessary to account for a positive deviation from BG target ;
computing an amount of carbohydrates, M(t), required to maintain BG target if u(t) is delivered in full, wherein:

M
⁡

(
t
)

=

max
⁢

{

0
,

[

u
⁡

(
t
)

-

B
⁢

R
⁡

(
t
)

k

-

U
^

correction

⁡

(
t
)

]

·
CR

}

,

60
k

 is the control update interval of insulin data in minutes, and CR is a self-assessed carbohydrate ratio, given in gCHO/U;
classifying said insulin delivery request signal as an excessive insulin request when BG proj (t)<BG thresh and M(t)>carb thresh ;

when SMBG at time t is not available:
computing M(t) using

Assignees

• Breton Marc D
• Patek Stephen D
• Kovatchev Boris P
• Hughes Colleen S
• Univ Virginia Patent Foundation

Inventors

• Breton Marc D
• Patek Stephen D
• Kovatchev Boris P
• Hughes Colleen S

Classifications

• G16H50/30

  for calculating health indices; for individual health risk assessment · CPC title

• G16H50/20

  for computer-aided diagnosis, e.g. based on medical expert systems · CPC title

• G16H40/63

  for local operation · CPC title

• G16H20/17 Primary

  delivered via infusion or injection · CPC title

• A61M5/16836

  by sensing tissue properties at the infusion site, e.g. for detecting infiltration (detecting tissue temperature for diagnostic purposes A61M39/0247) · CPC title