Method For Defining And Interactively Managing A Treatment For Glycemic Level Control In A Diabetic Patient And Device That Carries Out Said Method

• US 20110119081A1
• Filed: 07/03/2009
• Published: 05/19/2011
• Est. Priority Date: 07/10/2008
• Status: Abandoned Application

• Current Assignee: B.G. Informatica S.R.L.
• Original Assignee: B.G. Informatica S.R.L.
• Inventors: Vespasiani, Giacomo
• Application Number:
  US13/003,029
• Publication Number:
  US 20110119081A1
• Time in Patent Office: Days
• US Class Current: 705/2
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61M 5/00 Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests vaccination appliances for veterinary use A61D1/025 ; tube connectors, tube couplings, valves or branch units specially adapted for medical use A61M39/00; containers specially adapted for medical or pharmaceutical purposes A61J1/00; combinations of vial and syringe for mixing or transferring their contents A61J1/20; holders for containers for collecting, storing or administering blood or medical fluids A61J1/16
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 40/60 for the operation of medical equipment or devices
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems

Abstract

A method for interactive definition and management of a treatment for monitoring blood glucose of a diabetic patient includes performing two distinct, asynchronous and simultaneous, work cycles, having different length: a first local cycle, shorter, includes the steps of acquiring at least one value of said patient'"'"'s blood glucose by means of a glucometer integrated in a monitoring device, calculating an insulin dosage value to be administered to the patient, by means of a computing algorithm, provided by a specialist doctor, displaying the insulin dosage on a monitoring device display, and defining a date and time for subsequent acquisition of blood glucose level. Furthermore, the system automatically sends glycemic information to the doctor, if they are beyond mean value parameters, time passed from a last contact and number of hypoglycemic value measurements, that the specialist himself can set for each patient and modify over time. A second remote cycle, longer, includes reading the patient'"'"'s last blood glucose value, periodical running of a procedure for extracting a group of data significant for the patient, related to at least the trend of glycemic level values of the patient and to corresponding insulin doses, recommended on the basis of computation of said algorithm in a predetermined previous period; transmission of the group of significant date to the specialist'"'"' doctor'"'"'s remote computer, by means of a simplified transmitter/receiver module operating via a mobile telephone network, integrated with monitoring device, possibly receiving a set of modified parameters for performing the computing algorithm, or a new computing algorithm, and introduction of such set of modified parameters or of the new algorithm in the managing program.

Claims

1. A method for interactive definition and management of a treatment for controlling blood glucose level in a diabetic patient, said patient being provided with means for self-monitoring of the blood glucose level, aimed at measuring said patient'"'"'s glycemic values and at storing them as a digital code, said patient being also provided with remote information transmitter and receiver means, a data processing unit being associated to said self-monitoring means and/or to said remote transmitter and receiver means to run at least a management program for said treatment, said method being characterized in that it includes asynchronous and simultaneous performing of at least two distinct working cycles of different length:

a first cycle, local and shorter, including the steps of

acquiring at least one value of said patient'"'"'s blood glucose by means of said self-monitoring means and storing said value on a data area of said data processing unit;

computing a value of the insulin dose to administer to said patient, by means of a computing algorithm, provided by a specialist and performed by said management program, based on the acquired value of blood glucose and on the temporal trend of said blood glucose level in a previous period of time;

displaying said insulin dose on said data processing unit display,

defining a date and time for a subsequent measurement of the patient'"'"'s blood glucose level, and

setting the program to suggest the patient to measure it again at said date and time;

a second cycle, remote and longer, comprising;

reading, from said data area, by said management program, the last acquired value of the patient'"'"'s blood glucose;

periodically running a procedure for extracting, from said data area, a group of data significant for said patient, related to at least his trend of blood glucose values and to corresponding insulin doses, recommended on the basis of computation of said algorithm in a predetermined previous period;

automatically transmitting said group of significant data to said specialist'"'"'s remote computer, by means of said remote transmitting means,

possibly receiving, from said remote computer, a set of parameters modified for said computing algorithm, or a new computing algorithm, depending on deviation from said blood glucose trend with respect to an optimal one, and

installing said set of modified parameters or said new computing algorithm in said management program, for running the same in the aforesaid first local cycle.

2. A method according to claim 1, characterized in that said first cycle, local and shorter, comprises also a step, wherein said patient is asked, by means of said processor display, to measure his current blood glucose value, the moment of said request being determined by said computing algorithm.

3. A method according to claim 1, characterized in that said second cycle, remote and longer, includes also, after the last measurement of the patient'"'"'s blood glucose level, a step of evaluating the stability of said blood glucose trend over a pre-defined period of time, and, if necessary, performing said step of immediate transmission of significant data related to said trend, if it is considered unstable according to corresponding parameters supplied by said computing algorithm based on settings customized by the doctor for each patient.

4. A method according to claim 1, characterized in that said second cycle, remote and longer, comprises also, after said reading of the last blood glucose value, immediate preparing and transmission of significant data relating to blood glucose values trend, if said computing algorithm detects a severe hypoglycemia or hyperglycemia situation.

5. A device for interactive definition and management of a treatment for controlling blood glucose level in a diabetic patient, said patient being provided with blood glucose self-monitoring means, aimed at measuring the glycemic value of said patient and at storing it as a digital code, said patient being also provided with remote information transmitter and receiver means, a data processing unit being associated to said self-monitoring means and/or to said remote transmitter and receiver means, for running at least said treatment management program, said device being characterized in that it includes:

a digital glucometer, forming said self-monitoring means, said digital glucometer comprising said data processing unit;

a display, controlled by said data processing unit and electrically connected thereto;

a plurality of keys for input of data or commands, likewise electrically connected to said data processing unit;

said digital glucometer being also provided with a related simplified transmitter/receiver module operating via a mobile telephone network and controlled by said data processing unit, for receiving and transmitting data from and to at least one corresponding remote reception/transmission device, connected to a computer accessible by a specialist supervising the aforesaid medical treatment of the diabetic patient.

6. A device according to claim 5, characterized in that said simplified transmitter/receiver module is integrated in the structure of said digital glucometer.

7. A device according to claim 5, characterized in that, in said data processing unit, said management program for self-monitoring treatment includes at least one procedure aimed at implementing a computing algorithm of the patient'"'"'s insulin dosage, based on periodical information related to patient'"'"'s blood glucose level and to insulin doses actually taken by said patient in a given previous period of time.

8. A device according to claim 5, characterized in that, in said computer, said management program for self-monitoring treatment includes at least one local management procedure, aimed at implementing a first, local cycle, shorter, said procedure comprising instruction sequences for acquiring at least one blood glucose value of said patient by means of said self-monitoring means and for storing the value in a data area of said data processing unit, for calculation of an insulin dosage value to administer to said patient, by means of a computing algorithm, provided by the specialist, on the basis of acquired blood glucose value and of temporal trend of said blood glucose level in a previous period of time, for displaying said insulin dosage on said display, for defining of a date and time for the subsequent measurement of the blood glucose and instructions for warning said patient to perform said measurement in said date and on said time.

9. A device according to claim 5, characterized in that, in said computer, said management program for self-monitoring treatment includes at least one remote management procedure, aimed at implementing a second cycle, longer, said remote procedure comprising sequences of instructions for reading, from said data area, last patient'"'"'s blood glucose value, for periodical running of a procedure extracting a group of data significant for the patient, related to at least the patient'"'"'s trend of the blood glucose values and to his insulin doses recommended on the basis of a computation made by said algorithm in a previous predetermined period, for transmitting of said group of significant data to a remote computer, accessible by said specialist, by means of said remote transmission means, for possible receiving of a set of parameters modified on the basis of a deviation from said blood glucose trend with respect to the optimal one, for performing said computing algorithm, or a new computing algorithm, and for introducing said set of modified parameters or said new algorithm in said management program, for applying the same in the above mentioned first local cycle.