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Method, system and device to ensure statistical power for average pre and post-prandial glucose difference messaging

A technology of glucose concentration and difference, applied in blood characterization devices, healthcare informatics, computer-aided drug prescription/delivery, etc., can solve problems such as time-consuming, complex, and complicated evaluation

Inactive Publication Date: 2013-04-03
LIFESCAN SCOTLAND
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Accounting for numerous glucose concentration measurements in logbook format can be difficult, complex, and time-consuming in some cases
To further complicate matters, physicians typically have limited time constraints in assisting people with diabetes to interpret numerous glucose concentration measurements
In addition, evaluation is often further complicated by the physician's need to assess the effect of insulin or insulin type on the patient, as well as other physiological or extrinsic parameters

Method used

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  • Method, system and device to ensure statistical power for average pre and post-prandial glucose difference messaging
  • Method, system and device to ensure statistical power for average pre and post-prandial glucose difference messaging
  • Method, system and device to ensure statistical power for average pre and post-prandial glucose difference messaging

Examples

Experimental program
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Effect test

example 1

[0107] In an exemplary embodiment, use of a specified power of 80% (a standard level generally sufficient for use) provides a value of β = 1 - 80 / 100 = 0.2, which yields z from a suitable standard statistical table or function β= value of 0.8416. Furthermore, for a 100α% one-tailed test, with α=5% (i.e. 5% significance), z is also obtained from the statistical table α / 2 = 1.6449. Thus, according to the formula shown above for "K", this example provides a constant value,

[0108] K=(0.8416+1.6449) 2 =2.4865 2 =6.186 Formula 2

[0109] The sample size "m" for the statistical test may thus be at least:

[0110] m = K ( σ Δ ) 2 ≈ K ( s Δ ) 2 Formula 3

[0111] Generally, this is not an integer,...

example 2

[0146] As illustrated in Table 2, pre-meal and post-meal blood glucose measurements (in mg / dl) were collected from users over a twenty-day period. The columns "Day", "Pre" and "Post" in the main part of the table list the day, table pre-meal and post-meal measurements respectively.

[0147] Table 2

[0148]

[0149] The calculations used to determine whether the mean difference between pre-meal and post-meal glucose measurements are significant on a given day are described below. If there is a significant mean difference between pre-meal and post-meal glucose measurements, then if Figure 5 As illustrated in , the indication may be displayed on a screen of the glucose meter such as display device 500 . If the data in Table 2 correspond to meal types with only one type (such as breakfast, lunch, or dinner), the output of Table 2 can be used to generate Figure 5 One of the graphic bars (502, 504 or 506).

[0150] As an initial part of the calculation, the value K was se...

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Abstract

A diabetes management system and method are provided herein that may be used to analyze a patient's level of control of their diabetes, by looking at the difference between blood glucose measurements taken before and after a meal. If the standard deviation of the differences D calculated between pre- and post-prandial results is found to vary significantly from a predetermined threshold value, then a message or graphical indication may be displayed to the user. Messages may provide suggestions to the user as to ways to better manage their condition to ensure compliance of any prescribed diabetes regimen or to guide the patient in managing their diabetes.

Description

[0001] Stephen BLYTHE and Michael MALECHA [0002] This application, pursuant to 35 USC §§119, 120 or 365, claims the benefit of priority to US Provisional Patent Application 61 / 360,137, filed June 30, 2010, which is hereby incorporated by reference in its entirety. Background technique [0003] The incidence of diabetes is currently an outbreak all over the world. It is estimated that more than 44 million people in the United States alone have prediabetes and are unaware that they have the condition. Diabetes mellitus results in a loss of control over blood sugar concentrations. Complications caused by diabetes and especially high blood sugar (hyperglycemia) through loss of blood sugar control can be debilitating and even life threatening. The health costs for treating such complications can be significant. [0004] The groundbreaking study, the Diabetes Control and Complications Trial (DCCT), was conducted over 9 years (1984-1993) and involved 1,441 people with insulin-de...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61B5/145G06F19/00
CPCG06F19/10A61B5/14532G06F19/3406G06F19/345G06F19/3456G06F19/3487G16H40/63G16H50/20G16H15/00G16B99/00G16H20/60
Inventor S.布利瑟M.梅尔查
Owner LIFESCAN SCOTLAND
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