Analyte testing method and device for diabetes management

• US 8,974,387 B2
• Filed: 06/30/2010
• Issued: 03/10/2015
• Est. Priority Date: 09/29/2009
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: LifeScan Scotland Limited (Johnson & Johnson)
• Inventors: Shadforth, Ian, Price, David, Anderson, Gretchen, Comstock, Lorraine, McEvoy, Mary, Strachan, Alexander, Longmuir, Alistair, Cavaye, Robert, Teft, Gillian, Graham, Douglas
• Primary Examiner(s): Mallari, Patricia
• Assistant Examiner(s): TRAN, THO Q
• Application Number:
  US12/826,674
• Publication Number:
  US 20110077493A1
• Time in Patent Office: 1,714 Days
• Field of Search: 600/365, 600/316, 600/345, 600/347, 600/319, 600/300, 514/5.9, 514/6.1, 514/6.2, 514/6.3, 514/6.7, 514/6.8
• US Class Current: 600/365
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/486 Bio-feedback A61B5/375 takes precedence
• CPC Class Codes: A61B 5/4866 Evaluating metabolism A61B5/083 takes precedence
• CPC Class Codes: A61B 5/7282 Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• 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 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: H04L 67/12 specially adapted for proprietary or special-purpose networking environments, e.g. medical networks, sensor networks, networks in vehicles or remote metering networks

Abstract

Various embodiments are described and illustrated to calculate an insulin bolus, recommend such bolus, and provide reminder messages for performing an additional glucose test.

Claims

1. A method of managing blood glucose value of a diabetes user with a glucose measurement unit and a data management unit, each of the glucose measurement unit and the data management unit having respective processors, the method comprising:

conducting a plurality of glucose measurements from physiological fluids of a user with the glucose measurement unit that is coupled to a data management unit whereby glucose in the fluids is transformed into enzymatic byproducts during the measurements;

verifying with one of the glucose measurement unit and the data management unit, whether a most recent glucose measurement was made within a first predetermined time period different from a second predetermined time period which is different from a third predetermined time period;

based on the user'"'"'s selection of an estimation of carbohydrates or calculation carbohydrates, recommending an insulin bolus amount for (a) glucose correction only;

(b) carbohydrate coverage only;

or (c) both carbohydrate coverage and glucose correction, the recommending comprises;

verifying with one processor of either the glucose measurement unit or the data management unit, whether an insulin bolus amount for glucose correction was entered by the user within the third predetermined time period and if true then (a) warning the user that insulin may still be physiologically active to the user in a situation during which the user took insulin; and

(b) recommending an insulin amount for carbohydrate coverage only otherwise determining;

(1) whether a pre-meal flag is set with a glucose measurement conducted within the third predetermined time period and if true then (i) warning the user that insulin may still be physiologically active to the user in a situation during which the user took insulin; and

(ii) recommending an insulin amount for carbohydrate coverage, otherwise if not true then

(2) whether a latest glucose measurement is flagged as post-meal within the third predetermined time period and if true then (i) warning the user that insulin may still be physiologically active to the user in a situation during which the user took insulin; and

(ii) recommending an insulin amount for carbohydrate coverage with a warning that a full bolus calculation should be used with pre-meal glucose concentration; and

annunciating with the one processor, the insulin bolus recommendation;

treating the user with the insulin bolus recommendation.

2. The method of claim 1, in which each of the recommending of the insulin bolus amount for each one of (a) glucose correction only;

(b) carbohydrate coverage only;

or(c) both carbohydrate coverage and glucose correction comprises;

inputting an amount of carbohydrate to be ingested by the user; and

calculating the insulin bolus amount based on an insulin sensitivity of the user, insulin to carbohydrate ratio, and a target glucose value.

3. The method of claim 2 wherein the step of recommending further includes a recommendation of a default amount of carbohydrate to the user ranging from about 30 grams to about 50 grams.

4. The method of claim 3, in which the third predetermined time period comprises any value from about 3 hours to about 5 hours.