Methods and apparatus for decentralized diabetes monitoring

• US 8,775,095 B2
• Filed: 06/18/2010
• Issued: 07/08/2014
• Est. Priority Date: 06/18/2010
• Status: Expired due to Fees

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Walling, Paul Douglas, Surridge, Nigel
• Primary Examiner(s): Lau, Tung S
• Assistant Examiner(s): Chang, Stephanie
• Application Number:
  US12/818,781
• Publication Number:
  US 20110313673A1
• Time in Patent Office: 1,481 Days
• Field of Search: 702/19
• US Class Current: 702/19
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/4842 Monitoring progression or stage of a disease

Abstract

Methods for decentralized monitoring of a progression of a diabetic state of a patient include contemporaneously obtaining an initial set of venous blood samples and an initial set of capillary blood samples after a standardized metabolic challenge from the patient in a centralized setting, wherein the diabetic state is diagnosed using the initial set of venous blood samples and a first test baseline is established by correlating the initial set of capillary blood samples with the initial set of venous blood samples, implementing a therapy, performing decentralized testing after reaching a target event, wherein a status test is obtained from a status set of capillary blood samples obtained from the patient after a subsequent standardized metabolic challenge, and comparing the status test with the first test baseline to determine an effectiveness of the therapy.

Claims

1. A method for decentralized monitoring of a progression of a diabetic state of a patient with use of an electronic device, the method comprising:

obtaining a pre-test venous blood sample and a pre-test capillary blood sample from the patient after the patient fasts obtaining an initial set of venous blood samples and an initial set of capillary blood samples from the patient in a centralized setting after a standardized metabolic challenge, wherein the diabetic state is diagnosed using the initial set of venous blood samples and wherein a first test baseline is established by correlating the initial set of capillary blood samples with the initial set of venous blood samples;

implementing a therapy for the patient to address the diabetic state diagnosed by the initial set of venous blood samples;

performing decentralized testing after reaching a target event, wherein a status test is obtained from a status pre-test capillary blood sample obtained from the patient after the patient fasts and from a status set of capillary blood samples obtained from the patient after a subsequent standardized metabolic challenge; and

comparing the status test with the first test baseline to determine an effectiveness of the therapy.

2. The method of claim 1, wherein performing decentralized testing is repeated such that a plurality of status tests are compared with the first test baseline.

3. The method of claim 1 further comprising prescribing a subsequent therapy for the patient based on the effectiveness of the therapy.

4. The method of claim 3, wherein the subsequent therapy is a repeat of the therapy.

5. The method of claim 3 wherein the subsequent therapy is implemented based on comparing the status test with the first test baseline.

6. The method of claim 1, wherein the first test baseline and the status test comprises a plurality of biomarker values.

7. The method of claim 6, wherein the plurality of biomarker values comprise measurements of a patient'"'"'s glucose level, interstitial glucose level, heart rate or blood pressure.

8. The method of claim 1, wherein the initial set of capillary blood samples and the status set of capillary blood samples are obtained at standardized time intervals.

9. The method of claim 1, wherein the target event comprises a duration of time since the implementing the therapy.

10. The method of claim 1, wherein the therapy depends on the diabetic state.

11. The method of claim 1, further comprising:

implementing a subsequent therapy;

performing decentralized testing after reaching a subsequent target event, wherein a second status test is obtained from a second status set of capillary blood samples obtained from the patient after an additional standardized metabolic challenge;

comparing the second status test with the first test baseline to determine an effectiveness of the subsequent therapy; and

comparing the effectiveness of the therapy to the effectiveness of the subsequent therapy.

12. The method of claim 11, wherein a washout period is undergone between obtaining the status test from the status set of capillary blood samples and implementing the subsequent therapy.

13. An electronic device for decentralized monitoring of a progression of a diabetic state of a patient, the electronic device comprising:

a display;

an input terminal for inputting a first test baseline established using an initial set of capillary blood samples, wherein the initial set of capillary blood samples were obtained with an initial set of venous blood samples in a centralized setting, the initial set of venous blood samples being used to diagnose the diabetic state of the patient, and a plurality of status tests each established using a status set of capillary blood samples;

memory for storing the first test baseline, the plurality of status tests and instructions; and

a processor in communication with the memory and operable to execute the instructions, the instructions causing the processor to compare the plurality of status tests to the first test baseline such that an effectiveness of a therapy may be determined wherein the therapy was implemented between obtaining the initial set of capillary blood samples and each of the status sets of capillary blood samples.

14. The electronic device of claim 13, wherein the electronic device comprises a blood glucose meter.

15. The electronic device of claim 14, wherein the first test baseline and the plurality of status tests are each obtained using the blood glucose meter.

16. The electronic device of claim 13, wherein the first test baseline and each of the plurality of status tests comprise a plurality of biomarker values.

17. The electronic device of claim 16, wherein the plurality of biomarker values comprise measurements of a patient'"'"'s glucose level, interstitial glucose level, heart rate or blood pressure.

18. A decentralized testing kit for decentralized monitoring of a progression of a diabetic state of a patient, the decentralized testing kit comprising:

a plurality of standardized metabolic challenges;

a plurality of testing materials operable to obtain an initial set of capillary blood samples and to obtain a status set of capillary blood samples in a decentralized setting after a patient administers one of the plurality of standardized metabolic challenges, wherein the initial set of capillary blood samples are obtained with an initial set of venous blood samples in a centralized setting and wherein the plurality of testing materials are operable to measure a biomarker from each capillary blood sample such that a first test baseline is obtained by correlating the initial set of capillary blood samples with the initial set of venous blood samples and a status test is obtained from the status set of capillary blood samples obtained in the decentralized setting; and

tracking materials operable to compare the first test baseline with the status test to determine an effectiveness of a therapy implemented between the obtaining of the initial set of capillary blood samples and the status set of capillary blood samples.

19. The decentralized testing kit of claim 18 further comprising a glucose meter or a plurality of test strips.

20. The decentralized testing kit of claim 18 further comprising a lancing device and a plurality of lancets.