IP Library Granted Patent US 10,573,413
Granted Patent B2
US 10,573,413 · App. 13/803,465 · Granted Feb 25, 2020

Method for the detection and handling of hypoglycemia

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Quick Facts
Patent No.
US 10,573,413
App. No.
13/803,465
Granted
Feb 25, 2020
Kind
B2
Abstract

A method is described herein to detect and treat hypoglycemia. An example of this method involves the detection of hypoglycemia in a patient with a computing device, computation of a recommended carbohydrate amount to ingest by the patient with the computing device in response to said detecting the hypoglycemia, output of the recommended carbohydrate amount with the computing device, and the performance of a hypoglycemia surveillance with the computing device to determine whether the recommended carbohydrate amount remedied the hypoglycemia.

Claims (813)

1. A method, comprising:

detecting hypoglycemia in a patient with a computing device;

computing a recommended carbohydrate amount to ingest by the patient with the computing device in response to said detecting the hypoglycemia;

outputting the recommended carbohydrate amount with the computing device; and

performing hypoglycemia surveillance with the computing device to determine whether the recommended carbohydrate amount remedied the hypoglycemia, wherein the hypoglycemia surveillance includes:

receiving with the computing device a second blood glucose measurement of the patient after said computing the recommended carbohydrate amount;

determining with the computing device that the hypoglycemia has been remedied based at least on the second blood glucose measurement;

ending said performing the hypoglycemia surveillance when the second blood glucose measurement exceeds a relative threshold that varies based on amount of carbohydrates previously consumed, wherein the relative threshold is based on a time dependent carbohydrate absorption function that increases with time.

2. The method according to claim 1 , further comprising:

calculating with the computing device the relative threshold using the following formula

BG end,relative =γ( t−t 1 )· BG hypo,end +(1−γ( t−t 1 ))· BG 0

where:

BG end,relative =Relative threshold for ending the surveillance phase;

BG hypo,end =Threshold where hypoglycemia is considered ended;

γ(x)=Carbohydrate absorption function for time interval x;

t=Current time when relative threshold is being calculated;

t 1 =Time when first carbohydrate recommended or consumed; and

BG 0 =Original blood glucose measurement.

3. The method according to claim 1 , further comprising:

receiving a third blood glucose measurement;

calculating with the computing device the relative threshold using the following formula

BG

end

,

relative

=

γ

(

t

-

t

2

)

·

BG

hypo

,

end

+

(

1

-

γ

(

t

-

t

2

)

)

·

BG

2

+

γ

(

t

-

t

2

)

γ

(

t

2

-

t

1

)

(

γ

(

t

-

t

1

)

-

1

)

(

BG

2

-

BG

1

)

where:

BG end,relative =Relative threshold for ending the surveillance phase;

BG hypo,end =Threshold where hypoglycemia is considered ended;

γ(x)=Carbohydrate absorption function for time interval x;

t=Current time when relative threshold is being calculated;

t n =Time of n th measurement since hypoglycemia; and

BG n =n th blood glucose measurement since hypoglycemia.

4. The method according to claim 1 , further comprising:

receiving with the computing device data indicating that the patient lacks hypoglycemia symptoms after said computing the recommended carbohydrate amount; and

determining with the computing device that the hypoglycemia has been remedied based at least on the lack of the hypoglycemia symptoms.

5. The method according to claim 1 , further comprising:

delaying said performing the hypoglycemia surveillance for a delay period.

6. The method according to claim 5 , wherein the delay period is at least 15 minutes.

7. The method according to claim 1 , wherein the recommended carbohydrate amount is selected from a group consisting of a small carbohydrate amount, a medium carbohydrate amount, and a large carbohydrate amount.

8. The method according to claim 7 , wherein said computing the recommended carbohydrate amount includes selecting the small carbohydrate amount, the medium carbohydrate amount, and the large carbohydrate amount based on a very low blood glucose limit, a low blood glucose limit, and a medium-low blood glucose limit.

9. The method according to claim 8 , wherein the very low blood glucose limit, the low blood glucose limit, and the medium-low blood glucose limit are respectively 60 mg/dl, 100 mg/dl, and 140 mg/dl.

10. The method according to claim 8 , further comprising:

calculating with the computing device the recommended carbohydrate amount using the following formula

n

BU

=

{

0

if

BG

m

l

<

BG

n

BU

,

small

if

BG

1

<

BG

BG

m

l

n

BU

,

medium

if

BG

vl

<

BG

BG

1

n

BU

,

large

if

BG

BG

vl

Equation

21

where:

n BU =Amount of carbohydrate;

n BU,small =Small amount of carbohydrate;

n BU,medium =Medium amount of carbohydrate;

n BU,large =Large amount of carbohydrate;

BG 1 =Blood glucose measurement at hypoglycemia detection;

B ml =Medium-low blood glucose range limit;

BG 1 =Low blood glucose range limit; and

BG vl =Very low blood glucose range limit.

11. The method according to claim 8 , further comprising:

calculating the very low blood glucose limit, the low blood glucose limit, and the medium-low blood glucose limit based on no more than the last three blood glucose measurements.

12. The method according to claim 1 , further comprising:

normalizing the recommended carbohydrate amount based on patient weight.

13. The method according to claim 1 , further comprising:

adjusting the recommended carbohydrate amount based on patient weight, or risk of fainting during hypoglycemia.

14. The method according to claim 1 , further comprising:

adjusting the recommended carbohydrate amount based on a total daily dose of insulin by the patient.

15. The method according to claim 1 , further comprising:

calculating with the computing device the recommended carbohydrate amount using the following formula

{

n

BU

,

small

=

f

n

(

n

BU

,

TDD

+

n

BU

,

fainting

)

n

BU

,

medium

-

f

n

(

n

BU

,

TDD

+

n

BU

,

fainting

+

1

)

n

BU

,

large

=

f

n

(

n

BU

,

TDD

+

n

BU

,

fainting

+

2

)

where:

n BU,small =Small amount of carbohydrate;

n BU,medium =Medium amount of carbohydrate;

n BU,large =Large amount of carbohydrate;

f n =Normalization factor based on patient weight;

n BU,fainting =Risk of fainting additional bread unit; and

n BU,TDD =Additional bread unit recommended for patients with a total daily dose (TDD) of insulin ≤30 UI.

16. The method according to claim 1 , wherein said computing the recommended carbohydrate amount includes adjusting the recommended carbohydrate amount based on prior blood glucose measurements made after detecting the hypoglycemia, prior amounts of carbohydrates ingested, and a carbohydrate absorption function.

17. The method according to claim 1 , further comprising:

receiving a second blood glucose measurement after the patient ingested the second recommended amount of carbohydrate;

calculating with the computing device a second recommended carbohydrate amount using the following formula

{

BG

vl

,

2

=

γ

(

t

-

t

1

)

·

BG

vl

,

1

+

(

1

-

γ

(

t

-

t

1

)

)

·

BG

1

BG

l

,

2

=

γ

(

t

-

t

1

)

·

BG

l

,

1

+

(

1

-

γ

(

t

-

t

1

)

)

·

BG

1

BG

m

l

,

2

=

γ

(

t

-

t

1

)

·

BG

m

l

,

1

+

(

1

-

γ

(

t

-

t

1

)

)

·

BG

1

where:

BG vl,2 =Very low blood glucose range limit or threshold for a second amount of carbohydrate;

BG l,2 =Low blood glucose range limit or threshold for a second amount of carbohydrate;

BG ml,2 =Medium-low blood glucose range limit or threshold for a second amount of carbohydrate;

γ(x)=Carbohydrate absorption function for time interval x;

t=Current time when relative threshold is being calculated;

t 1 =Time when first carbohydrate was consumed; and

BG 1 =First blood glucose measurement.

18. The method according to claim 17 , further comprising:

receiving a third blood glucose measurement after the patient ingested the second recommended amount of carbohydrate;

calculating with the computing device a third recommended carbohydrate amount using the following formula

{

BG

vl

,

3

=

γ

(

t

-

t

2

)

·

BG

vl

,

3

+

(

1

-

γ

(

t

-

t

2

)

)

·

BG

2

+

γ

(

t

-

t

2

)

γ

(

t

2

-

t

1

)

(

γ

(

t

-

t

1

)

-

1

)

(

BG

2

-

BG

1

)

BG

l

,

3

=

γ

(

t

-

t

2

)

·

BG

l

,

3

+

(

1

-

γ

(

t

-

t

2

)

)

·

BG

2

+

γ

(

t

-

t

2

)

γ

(

t

2

-

t

1

)

(

γ

(

t

-

t

1

)

-

1

)

(

BG

2

-

BG

1

)

BG

m

l

,

3

=

γ

(

t

-

t

2

)

·

BG

m

l

,

3

+

(

1

-

γ

(

t

-

t

2

)

)

·

BG

2

+

γ

(

t

-

t

2

)

γ

(

t

2

-

t

1

)

(

γ

(

t

-

t

1

)

-

1

)

(

BG

2

-

BG

1

)

where:

BG vl,3 =Very low blood glucose range limit or threshold for a third amount of carbohydrate (i.e., at time t3);

BG l,3 =Low blood glucose range limit or threshold for a third amount of carbohydrate (i.e., at time t3);

BG ml,3 =Medium-low blood glucose range limit or threshold for a third amount of carbohydrate (i.e., at time t3);

γ(x)=Carbohydrate absorption function for time interval x;

t=Current time when relative threshold is being calculated;

t n =Time of n th measurement since hypoglycemia; and

BG n =n th blood glucose measurement since hypoglycemia.

19. The method according to claim 1 , further comprising:

calculating subsequent amounts of carbohydrates by superimposing the effects of previous carbohydrate amounts.

20. The method according to claim 1 , further comprising:

calculating with the computing device the carbohydrate absorption function using the following formula

{

γ

(

x

)

=

0

if

x

=

0

γ

(

x

)

=

-

0.000125

·

x

2

+

0.022525

·

x

+

0.0019

if

0

<

x

<

78

γ

(

x

)

=

1

if

x

78

where:

γ(x)=Carbohydrate absorption function; and

x=Time frame of interest (in minutes).

21. The method according to claim 1 , further comprising:

calculating with the computing device the carbohydrate absorption function using the following formula

{

γ

(

x

)

=

-

1

t

a

2

x

2

+

2

t

a

x

if

0

x

t

a

γ

(

x

)

=

1

if

x

>

t

a

where:

γ(x)=Carbohydrate absorption function;

x=Time frame of interest (in minutes); and

t a =Total carbohydrate absorption time.

22. The method according to claim 1 , further comprising:

calculating with the computing device the carbohydrate absorption function using the following formula

{

γ

(

x

)

=

-

1

t

a

x

if

0

x

t

a

γ

(

x

)

=

1

if

x

>

t

a

where:

γ(x)=Carbohydrate absorption function;

x=Time frame of interest (in minutes); and

t a =Total carbohydrate absorption time.

23. The method according to claim 1 , further comprising:

calculating with the computing device the carbohydrate absorption function using the following formula

γ( x )=1 −e −a·x

where:

γ(x)=Carbohydrate absorption function;

x=Time frame of interest (in minutes); and

a=0.03.

24. The method according to claim 1 , further comprising:

calculating with the computing device the carbohydrate absorption function using the following formula

γ( x )=1 −e −a·x 2 −bx

where:

γ(x)=Carbohydrate absorption function;

x=Time frame of interest (in minutes);

a=0.0004; and

b=0.015.

25. The method according to claim 1 , wherein the carbohydrate absorption function is a linear function.

26. The method according to claim 1 , wherein the carbohydrate absorption function is a parabolic function.

27. The method according to claim 1 , wherein the carbohydrate absorption function is an exponential function.

28. The method according to claim 1 , further comprising:

receiving with the computing device a manual input that the patient has the symptom of hypoglycemia.

29. The method according to claim 1 , further comprising:

determining automatically with the computing device that the patient has the symptom of hypoglycemia.

30. The method according to claim 29 , wherein said determining automatically includes analyzing results from a questionnaire to detect hypoglycemic symptoms with the computing device.

31. The method according to claim 29 , wherein said determining automatically includes analyzing a video of the patient for the hypoglycemic symptoms with the computing device.

32. The method according to claim 29 , wherein said determining automatically includes analyzing speech of the patient for the hypoglycemic symptoms with the computing device.

33. A computerized method of detecting and treating hypoglycemia, comprising:

receiving with a computing device a blood glucose measurement of a patient;

computing a recommended carbohydrate amount to ingest by the patient with the computing device, wherein the recommended carbohydrate amount is based at least on the blood glucose measurement of the patient, wherein said computing the recommended carbohydrate amount includes adjusting the recommended carbohydrate amount based on an amount of carbohydrates consumed by the patient during a timeframe;

outputting the recommended carbohydrate amount with the computing device to provide the patient with a visual representation of a recommendation to treat hypoglycemia and return a blood glucose level of the patient back to a non-hypoglycemic level; and

performing hypoglycemia surveillance with the computing device after a delay period to determine whether the recommended carbohydrate amount remedied the hypoglycemia, wherein the recommendation and the surveillance after the delay period assists with reducing the length of or eliminating hypoglycemia and ensures resolution of hypoglycemic events, wherein the hypoglycemia surveillance includes:

receiving with the computing device a second blood glucose measurement of the patient after said computing the recommended carbohydrate amount;

determining with the computing device that the hypoglycemia has been remedied based at least on the second blood glucose measurement;

ending said performing the hypoglycemia surveillance when the second blood glucose measurement exceeds a relative threshold that varies based on amount of carbohydrates previously consumed, wherein the relative threshold is based on a time dependent carbohydrate absorption function that increases with time.

34. A computerized method of detecting and treating hypoglycemia, comprising:

detecting hypoglycemia in a patient with a computing device based at least on the patient having a symptom of hypoglycemia;

receiving with the computing device a blood glucose measurement of the patient;

computing a recommended carbohydrate amount to ingest by the patient with the computing device in response to said detecting the hypoglycemia, wherein the recommended carbohydrate amount is based at least in part on the blood glucose measurement of the patient;

outputting the recommended carbohydrate amount with the computing device to provide the patient with a visual representation of a recommendation to treat hypoglycemia and return a blood glucose level of the patient back to a non-hypoglycemic level in a manner that assists with reducing the length of or eliminating hypoglycemia and ensures resolution of hypoglycemic events; and

performing hypoglycemia surveillance with the computing device to determine whether the recommended carbohydrate amount remedied the hypoglycemia, wherein the hypoglycemia surveillance includes:

receiving with the computing device a second blood glucose measurement of the patient after said computing the recommended carbohydrate amount;

determining with the computing device that the hypoglycemia has been remedied based at least on the second blood glucose measurement;

ending said performing the hypoglycemia surveillance when the second blood glucose measurement exceeds a relative threshold that varies based on amount of carbohydrates previously consumed, wherein the relative threshold is based on a time dependent carbohydrate absorption function that increases with time.

35. The method according to claim 34 , wherein said computing the recommended carbohydrate amount includes adjusting the recommended carbohydrate amount based on amount of carbohydrates consumed by the patient during a timeframe.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 23, 2015
From: ROCHE DIAGNOSTICS OPERATIONS, INC.
To: ROCHE DIABETES CARE, INC.
Reel/Frame 036008/0670 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 8, 2015
From: PROD'HOM, GILLES; TEUPE, BERNHARD
To: ROCHE DIAGNOSTICS INTERNATIONAL AG
Reel/Frame 034666/0926 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 5, 2014
From: GREENBURG, ALAN; ZIVITZ, MAURY
To: ROCHE DIAGNOSTICS OPERATIONS, INC.
Reel/Frame 032351/0640 →