Device and method for preventing hypoglicemia

• US 10,350,354 B2
• Filed: 06/20/2008
• Issued: 07/16/2019
• Est. Priority Date: 06/21/2007
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Yodfat, Ofer, Shapira, Gali, Ramchandani, Neesha
• Primary Examiner(s): Patel, Shefali D
• Application Number:
  US12/143,611
• Publication Number:
  US 20090030398A1
• Time in Patent Office: 4,043 Days
• Field of Search: 604131, 604151, 604500, 604503, 604504, 604 65, 604 66, 604 67
• 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 for prevention of hypoglycemia are disclosed. In one aspect, the device and the 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 a level of glucose in the patient'"'"'s body substantially at a beginning of the fasting time period (e.g. before bedtime); receiving a first set of parameters corresponding to a medical state of the patient; determining a therapeutic course of action based on the levels of the TBG, BBG and the medical state of the patent; and administering the therapeutic course of action to the patient.

Claims

1. A method for glycemic control to prevent hypoglycemia during a fasting time period, comprising:

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

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

receiving a first set of parameters comprising the patient'"'"'s insulin sensitivity (IS), the patient'"'"'s carbohydrate to insulin ratio (CIR), and the patient'"'"'s residual insulin (RI), said RI corresponding to a level of residual insulin in the patient'"'"'s body substantially at the beginning of the fasting time period;

comparing the BBG level against the TBG level; and

determining a therapeutic course of action including adjusting the patient'"'"'s basal rate (BR) based on the levels of the TBG, the BBG and the first set of parameters wherein the therapeutic course of action includes;

(a) advising the patient to consume a calculated amount of carbohydrates (CC), with the calculated amount of carbohydrates (CC) being calculated in the following ways;

(i) CC=CIR*(RI+((TBG−

BBG)/IS)) when BBG<

TBG and the RI>

0,

(ii) CC=(CIR*(TBG−

BBG))/IS when BBG<

TBG, and the RI is substantially negligible, and

(iii) CC=CIR*(RI+((TBG−

BBG)/IS)) when BBG>

TBG and RI>

(BBG−

TBG)/IS, and

(b) administering a correction bolus (CB) in the patient'"'"'s body, based upon (i) the comparison of the BBG level against the TBG level and (ii) the determined therapeutic course of action, with the correction bolus (CB) being calculated in the following ways;

(i) CB=(BBG−

TBG)/IS when BBG>

TBG and there is substantially no RI, and

(ii) CB=(BBG−

TBG)/IS−

RI when BBG>

TBG and (BBG−

TBG)/IS >

RI.

2. The method of claim 1, wherein the therapeutic course of action further includes allowing the patient to choose an amount of carbohydrates which is less than the calculated amount of carbohydrates (CC) and one of:

adjusting the BR to a modified basal rate (BR′

), and

advising the patient to adjust the BR to the modified basal rate (BR′

).

3. The method of claim 2, further comprising adjusting the patient'"'"'s basal rate (BR) for a time segment (t)=n/BR to the modified basal rate (BR′

) if the BBG level is less than the TBG level, the BR is substantially constant and the RI is substantially negligible, wherein the BR′

=(IS′

/IS)*BR, and IS′

=IS−

(TBG−

BBG)/n, wherein IS′

is a temporal IS value of the patient, and where n is a positive integer number.

4. The method of claim 2, further comprising adjusting the BR for a time segment (t)=n/BR to the modified basal rate (BR′

) if BBG<

TBG and RI>

0 and the patient'"'"'s basal rate (BR) is substantially constant;

wherein IS′

is a temporal IS value of the patient, BG_ed is an expected decrease in BG, and

wherein;

n is a positive number;

BR′

=(IS′

/IS)*BR;

IS′

=−

((TBG−

(BBG−

BG_ed)/n; and

,

BG_ed=IS*RI.

5. The method of claim 2, further comprising adjusting the patient'"'"'s basal rate (BR) to the modified basal rate (BR′

) upon determining that the BR is substantially inconstant.

6. The method of claim 2, further comprising adjusting the BR to the modified basal rate (BR′

) upon determining ((BBG<

TBG and RI≥

0) or (BBG>

TBG and RI>

CB)) and the patient'"'"'s basal rate (BR) substantially changes over time, wherein

7. The method according to claim 6 wherein if a time segment (t₁) is longer than a predefined time segment (T), then the adjustment is limited to T according to the following:

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

b. IS′

₁=IS−

Δ

/n₁−

RI*IS/n₁;

c. If IS′

₁>

0 then BR′

₁=(IS′

₁/IS)*BR for time segment (T);

wherein;

n₁ is an amount of insulin (in units) that is administered in the time segment t₁;

IS′

₁ is an overall decrease in blood glucose in the time segment t₁; and

BR′

₁ is a modified (adjusted) basal rate for the time segment t₁.

8. The method of claim 2, wherein the adjustment of the patient'"'"'s basal rate is reducing the patient'"'"'s basal rate.

9. The method of claim 1, wherein the fasting time period corresponds to a nocturnal time period.

10. A non-transitory computer readable medium comprising computer-executable instructions recorded thereon for performing the method of claim 1.

11. The method of claim 1, wherein the adjustment of the patient'"'"'s basal rate is reducing the patient'"'"'s basal rate.

12. A device for glycemic control to prevent hypoglycemia during a fasting time period, comprising:

a processor which receives;

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

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

a first set of parameters comprising the patient'"'"'s insulin sensitivity (IS), the patient'"'"'s carbohydrate to insulin ratio (CIR), and the patient'"'"'s residual insulin (RI), said RI corresponding to a level of residual insulin in the patient'"'"'s body substantially at the beginning of the fasting time period, and

wherein said processor;

compares the BBG level against the TBG level; and

determines a therapeutic course of action that includes an adjustment to the patient'"'"'s basal rate (BR) based on the levels of the TBG, the BBG, and the first set of parameters, and

wherein the therapeutic course of action includes;

(a) advice to the patient to consume a calculated amount of carbohydrates (CC), with the calculated amount of carbohydrates (CC) calculated and advised by the processor in the following ways;

(i) CC=CIR*(RI+((TBG−

BBG)/IS)) when BBG<

TBG and the RI>

0,

(ii) CC=(CIR*(TBG−

BBG))/IS when BBG<

TBG, and the RI is substantially negligible, and

(iii) CC=CIR*(RI+((TBG−

BBG)/IS)) when BBG>

TBG and RI>

(BBG−

TBG)/IS, and

(b) a correction bolus (CB) administered in the patient'"'"'s body, based upon (i) the comparison of the BBG level against the TBG level and (ii) the determined therapeutic course of action, with the correction bolus (CB) calculated by the processor in the following ways;

(i) CB=(BBG−

TBG)/IS when BBG>

TBG and there is substantially no RI, and

(ii) CB=(BBG−

TBG)/IS−

RI when BBG>

TBG and (BBG−

TBG)/IS>

RI.

13. The device of claim 12, wherein the therapeutic course of action further includes a patient selected amount of carbohydrates which is less than the calculated amount of carbohydrates (CC) and one of:

an adjustment to the BR to a modified basal rate (BR′

), and

advice to the patient to adjust the BR to the BR′

.

14. The device of claim 13, 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), the therapeutic course of action includes an adjustment of the BR for a time segment (t)=n/BR to the modified basal rate (BR′

), wherein the BR′

=(IS′

/IS)*BR, wherein IS′

is a temporal IS value of the patient, n is a positive integer number, and wherein IS′

=IS−

(TBG−

BBG)/n.

15. The device of claim 13, wherein if BBG<

TBG and RI >

0 and the patient'"'"'s basal rate (BR) is substantially constant, the therapeutic course of action includes an adjustment of the BR for a time segment (t)=n/BR to the modified basal rate (BR′

);

wherein IS′

is a temporal IS value of the patient, BG_ed is an expected decrease in BG, and n is a positive number;

wherein BR′

=(IS′

/IS)*BR;

wherein IS′

=IS−

((TBG−

(BBG−

BG_ed)/n); and

,

wherein BG_ed=IS*RI.

16. The device of claim 13, wherein if the patient'"'"'s basal rate (BR) is substantially inconstant, the therapeutic course of action includes the processor adjusting the BR to the modified basal rate (BR′

).

17. The device of claim 13, wherein if ((BBG<

TBG and RI>

0) or (BBG>

TBG and RI>

CB)) and the patient'"'"'s basal rate (BR) substantially changes over time, the therapeutic course of action includes the processor adjusting the BR to the modified basal rate (BR′

), wherein

18. The device according to claim 17 wherein if a time segment (t₁) is longer than a predefined time segment (T), then the adjustment is limited to T according to the following:

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

b. IS′

₁=IS−

Δ

/n₁−

RI*IS/n₁;

c. If IS′

₁>

0 then BR′

₁=(IS′

₁/IS) * BR for the time segment (T);

wherein;

n₁ is an amount of insulin (in units) that is administered in the time segment t₁;

IS′

₁ is an overall decrease in blood glucose in the time segment t₁; and

BR′

₁ is a modified (adjusted) basal rate for the time segment t₁.

19. The device of claim 12, wherein the fasting time period corresponds to a nocturnal time period.

20. The device of claim 12, further comprising a remotely controlled skin adherable unit.

21. The device of claim 20, 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.

22. The device of claim 12, wherein the adjustment of the patient'"'"'s basal rate is reducing the patient'"'"'s basal rate.

23. The device of claim 12, wherein the device is an insulin infusion pump unit.

24. The device of claim 12, wherein the device is a remote control unit to a patch unit within an insulin infusion device, the insulin infusion device has the patch unit and the remote control unit communicates with the patch unit.

25. The device of claim 12, wherein the device is a glucose measurement unit.