Device and method for preventing hypoglycemia

• US 20090030398A1
• Filed: 06/20/2008
• Published: 01/29/2009
• Est. Priority Date: 06/21/2007
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Ramchandani, Neesha, Shapira, Gali, Yodfat, Ofer
• Granted Patent: US 10,350,354 B2
• Time in Patent Office: Days
• US Class Current: 604/504
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2005/14268 with a reusable and a disposable component
• CPC Class Codes: A61M 2005/1726 the body parameters being measured at, or proximate to, the infusion site
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 50/50 for simulation or modelling of medical disorders

Abstract

A device and a method are provided that can be used for prevention of hypoglycemia. In one aspect, a device and a method for prevention of hypoglycemia can comprise receiving a target blood glucose (TBG) level corresponding to a desired level of glucose in a patient'"'"'s body during a fasting time period; receiving a bedtime blood glucose (BBG) level corresponding to the level of glucose in the patient'"'"'s body substantially at the beginning of the fasting time period; receiving a first set of parameters corresponding to a medical state of the patient; providing the levels of the TBG, BBG and the medical state of the patent to a therapeutic course of action determining means; and, providing means for administering the therapeutic course of action to the patient.

Claims

8-1. The device of claim 21, wherein if BBG>

TBG and RI>

CB, then CC=CIR*(RI+((TBG−

BBG)/IS)).

16. A method for preventing hypoglycemia comprising:

receiving a target blood glucose (TBG) level corresponding to a desired level of glucose in a patient'"'"'s body during a fasting time period;

receiving a bedtime blood glucose (BBG) level corresponding to the level of glucose in the patient'"'"'s body substantially at the beginning of the fasting time period;

receiving a first set of parameters comprising the patient'"'"'s insulin sensitivity (IS) and the patient'"'"'s carbohydrate to insulin ratio (CIR);

providing the levels of the TBG, BBG and the first set of parameters to a therapeutic course of action determining means; and

,

providing means for administering the therapeutic course of action to the patient.

17. The method of claim 16, wherein the therapeutic course of action includes at least one of the advising the patient to consume a calculated amount of carbohydrates (CC), adjusting the patient'"'"'s basal rate (BR), advising the patient to adjust the BR, administering a correction bolus (CB), advising the patient to administer the CB.

18. The method of claims 17, wherein the first set of parameters further comprises the patient'"'"'s residual insulin (RI), said RI corresponding to the level of residual insulin in the patient'"'"'s body substantially at the beginning of the fasting time period.

19. A device for preventing hypoglycemia comprising:

at least one module adapted for receiving a target blood glucose (TBG) level corresponding to a desired level of glucose in a patient'"'"'s body during a fasting time period;

at least one module adapted for receiving a bedtime blood glucose (BBG) level corresponding to the level of glucose in the patient'"'"'s body substantially at the beginning of the fasting time period;

at least one module adapted for receiving a first set of parameters comprising the patient'"'"'s insulin sensitivity (IS) and the patient'"'"'s carbohydrate to insulin ratio (CIR);

at least one module adapted for determining a therapeutic course of action based on the levels of the TBG, BBG and the first set of parameters; and

,

at least one module adapted for administering the therapeutic course of action to the patient.

1. A method for preventing hypoglycemia comprising:

receiving a target blood glucose (TBG) level corresponding to a desired level of glucose in a patient'"'"'s body during a fasting time period;

receiving a bedtime blood glucose (BBG) level corresponding to the level of glucose in the patient'"'"'s body substantially at the beginning of the fasting time period;

receiving a first set of parameters comprising the patient'"'"'s insulin sensitivity (IS) and the patient'"'"'s carbohydrate to insulin ratio (CIR);

determining a therapeutic course of action based on the levels of the TBG, BBG and the first set of parameters; and

,

administering the therapeutic course of action to the patient.

2. The method of claim 1, wherein the therapeutic course of action includes at least one of the advising the patient to consume a calculated amount of carbohydrates (CC), adjusting the patient'"'"'s basal rate (BR), advising the patient to adjust the BR, administering a correction bolus (CB), advising the patient to administer the CB.

3. The method of claims 2, wherein the first set of parameters further comprises the patient'"'"'s residual insulin (RI), said RI corresponding to the level of residual insulin in the patient'"'"'s body substantially at the beginning of the fasting time period.

4. The method of claims 3, wherein if the BBG is less than the TBG and the patient'"'"'s basal rate (BR) is substantially constant and the RI is substantially negligible, then for any positive number (n), adjusting the BR for a time segment (t)=n/BR to a modified basal rate (BR′

), wherein the BR′

=(IS′

/IS)*BR, wherein the IS′

=IS−

(TBG−

BBG)/n.

5. The method of claim 3, wherein if BBG<

TBG and RI>

0 and the patient'"'"'s basal rate (BR) is substantially constant, adjusting the BR for a time segment (t)=n/BR to a modified basal rate (BR′

);

wherein n is a positive number;

wherein BR′

=(IS′

/IS)*BR;

wherein IS′

=IS−

((TBG−

(BBG−

BG_ed))/n); and

,

wherein BGed=IS*RI.

6. The method of claim 3, wherein if BBG>

TBG and there is substantially no RI, a correction bolus (CB) is administered, such that CB=(BBG−

TBG)/IS.

7. The method of claim 3, wherein if BBG>

TBG and (BBG−

TBG)/IS>

RI, then CB=(BBG−

TBG)/IS−

RI.

8. The method of claim 3, wherein if BBG>

TBG and RI>

CB, then CC=CIR*(RI+((TBG−

BBG)/IS)).

9. The method of claim 3, wherein if BBG<

TBG, and the RI is substantially negligible, then CC=(CIR*(TBG−

BBG))/IS.

10. The method of claim 3, wherein if BBG<

TBG and the RI>

0, then CC=CIR*(RI+((TBG−

BBG)/IS)).

11. The method of claim 3, wherein if the BR is substantially inconstant, adjusting the BR to BR′

using means for adjusting the inconstant bolus rate.

12. The method of claim 3, wherein if ((BBG<

TBG and RI≧

0) or (BBG>

TBG and RI>

CB)) and BR substantially changes over time, adjusting the BR to BR′

, wherein

$\underset{y=1,2,3<br><br>\mathrm{\dots <br><br>}}{{\mathrm{IS}}_y^{\mathrm{\prime <br><br>}}}=\mathrm{IS}-\frac{\mathrm{\Delta <br><br>}}{n_y}-\frac{{\mathrm{BG}}_{\mathrm{ed}}}{n_y}+\frac{\underset{x=1}{\overset{x=y-1}{\sum <br><br>}}<br><br><br><br>\mathrm{IS}*n_x}{n_y}-\frac{\underset{x=1}{\overset{x=y-1}{\sum <br><br>}}<br><br><br><br>\mathrm{IS}*n_{\min }<br><br>{,}_x}{n_y};<br><br>$

wherein y is a period of time in which BR is substantially constant;

wherein;

$\mathrm{\Delta <br><br>}=\mathrm{TBG}-\mathrm{BBG};<br><br>$ $n_y=t_y*{\mathrm{BR}}_y;<br><br>$ $n_x=t_x*{\mathrm{BR}}_x;<br><br>$ $n_{\min ,x}=t_x*{\mathrm{BR}}_{\min <br><br>\left({\mathrm{BR}}_{\min }=\mathrm{minimal}<br><br><br><br><br><br>\mathrm{possible}<br><br><br><br>\mathrm{basal}<br><br><br><br><br><br>\mathrm{rate}\right);<br><br>}$ ${\mathrm{BG}}_{\mathrm{ed}}=\mathrm{IS}*\mathrm{RI},\mathrm{and}$ ${\mathrm{BR}}_y=\frac{{\mathrm{IS}}_y^{\mathrm{\prime <br><br>}}}{\mathrm{IS}}*\mathrm{BR}.$

13. A method according to claim 12 wherein if the time segment (t₁) is longer than a predefined T, then the modification is limited to T according to the following:

a. n₁=T*BRc, wherein BRc is the basal rate at the constant time segment;

b. IS′

₁=IS−

Δ

/n₁−

RI*IS/n₁,

c. If IS′

₁>

0 than BR′

₁=(IS′

₁/IS)*BR for time segment “

T”

.

14. The method of claim 3, wherein the patient is advised to consume a modified calculated amount of carbohydrates CC and the patient is also advised to adjust the basal rate (BR).

15. The method of claim 3, wherein the fasting time period corresponds to a nocturnal time period.

20. The device of claim 19, wherein the therapeutic course of action includes at least one of the advising the patient to consume a calculated amount of carbohydrates (CC), adjusting the patient'"'"'s basal rate (BR), advising the patient to adjust the BR, administering a correction bolus (CB), advising the patient to administer the CB.

21. The device of claims 20, wherein the first set of parameters further comprises the patient'"'"'s residual insulin (RI), said RI corresponding to the level of residual insulin in the patient'"'"'s body substantially at the beginning of the fasting time period.

22. The device of claim 21, wherein if the BBG is less than the TBG and the patient'"'"'s basal rate (BR) is substantially constant and the RI is substantially negligible, then for any number (n), adjusting the BR for a time segment (t)=n/BR to a modified basal rate (BR′

), wherein the BR′

=(IS′

/IS)*BR, wherein the IS′

=IS−

(TBG−

BBG)/n.

23. The device of claim 21, wherein if BBG<

TBG and RI>

0 and the patient'"'"'s basal rate (BR) is substantially constant, adjusting the BR for a time segment (t)=n/BR to a modified basal rate (BR′

);

wherein n is a positive integer number;

wherein BR′

=(IS′

/IS)*BR;

wherein IS′

=IS−

((TBG−

(BBG−

BG_ed))/n); and

,

wherein BGed=IS*RI.

24. The device of claim 21, wherein if BBG>

TBG and there is substantially no RI, a correction bolus (CB) is administered, such that CB=(BBG−

TBG)/IS.

25. The device of claim 21, wherein if BBG>

TBG, then CB=(BBG−

TBG)/IS−

RI.

26. The device of claim 21, wherein if BBG<

TBG, and the RI is substantially negligible, then CC=(CIR*(TBG−

BBG))/IS.

27. The device of claim 21, wherein if BBG<

TBG and the RI>

0, then CC=CIR*(RI+((TBG−

BBG)/IS)).

28. The device of claim 21, wherein if the BR is substantially inconstant, adjusting the BR to BR′

using means for adjusting the inconstant bolus rate.

29. The device of claim 21, wherein if ((BBG<

TBG and RI>

0) or (BBG>

TBG and RI>

CB)) and BR substantially changes over time, adjusting the BR to BR′

, wherein

$\underset{y=1,2,3<br><br>\mathrm{\dots <br><br>}}{{\mathrm{IS}}_y^{\mathrm{\prime <br><br>}}}=\mathrm{IS}-\frac{\mathrm{\Delta <br><br>}}{n_y}-\frac{{\mathrm{BG}}_{\mathrm{ed}}}{n_y}+\frac{\underset{x=1}{\overset{x=y-1}{\sum <br><br>}}<br><br><br><br>\mathrm{IS}*n_x}{n_y}-\frac{\underset{x=1}{\overset{x=y-1}{\sum <br><br>}}<br><br><br><br>\mathrm{IS}*n_{\min }<br><br>{,}_x}{n_y};<br><br>$

wherein y is a period of time in which BR is substantially constant;

wherein;

$\mathrm{\Delta <br><br>}=\mathrm{TBG}-\mathrm{BBG};<br><br>$ $n_y=t_y*{\mathrm{BR}}_y;<br><br>$ $n_x=t_x*{\mathrm{BR}}_x;<br><br>$ $n_{\min ,x}=t_x*{\mathrm{BR}}_{\min <br><br>\left({\mathrm{BR}}_{\min }=\mathrm{minimal}<br><br><br><br><br><br>\mathrm{possible}<br><br><br><br>\mathrm{basal}<br><br><br><br><br><br>\mathrm{rate}\right);<br><br>}$ ${\mathrm{BG}}_{\mathrm{ed}}=\mathrm{IS}*\mathrm{RI},\mathrm{and}$ ${\mathrm{BR}}_y=\frac{{\mathrm{IS}}_y^{\mathrm{\prime <br><br>}}}{\mathrm{IS}}*\mathrm{BR}.$

30. A device according to claim 29 wherein if the time segment (t₁) is longer than a predefined T, then the modification is limited to T according to the following:

d. n₁=T*basal (c)

e. IS′

₁=IS−

Δ

/n₁−

RI*IS/n₁

f. If IS′

₁>

0 than Basal′

₁=(IS′

₁/IS)*basal for time segment “

T”

.

31. The device of claim 21, wherein the patient is advised to consume a modified calculated amount of carbohydrates CC and the patient is also advised to adjust the BR.

32. The device of claim 21, wherein the fasting time period corresponds to a nocturnal time period.

36. The device of claim 19, further comprising a remotely controlled skin adherable unit.

37. The device of claim 36, wherein the remotely controlled skin adherable unit is controllable by one or more bolus buttons and is connectable to and disconnectable from the patient'"'"'s body.

33. A device for preventing hypoglycemia comprising:

means for receiving a target blood glucose (TBG) level corresponding to a desired level of glucose in a patient'"'"'s body during a fasting time period;

means for receiving a bedtime blood glucose (BBG) level corresponding to the level of glucose in the patient'"'"'s body substantially at the beginning of the fasting time period;

means for receiving a first set of parameters comprising the patient'"'"'s insulin sensitivity (IS) and the patient'"'"'s carbohydrate to insulin ratio (CIR);

means for determining a therapeutic course of action using the levels of the TBG, BBG and the first set of parameters; and

,

means for administering the therapeutic course of action to the patient.

34. The device of claim 33, wherein the therapeutic course of action includes at least one of the advising the patient to consume a calculated amount of carbohydrates (CC), adjusting the patient'"'"'s basal rate (BR), advising the patient to adjust the BR, administering a correction bolus (CB), advising the patient to administer the CB.

35. The device of claims 34, wherein the first set of parameters further comprises the patient'"'"'s residual insulin (RI), said RI corresponding to the level of residual insulin in the patient'"'"'s body substantially at the beginning of the fasting time period.