Patent Application
20110092788
The present invention relates generally to systems and methods for providing guidance in administration of a medicine, and in particular, systems and methods for providing such guidance using a portable electronic device.
Insulin may usually be administered through subcutaneous injections, e.g., using syringes with needles, insulin pumps, insulin pens with needles, etc. Administration schedules may attempt to mimic the physiologic secretion of insulin by the pancreas. In these cases, both a long-acting insulin and a short-acting insulin may be used.
It is important to administer the proper insulin. Cases where an improper insulin was administered (e.g., short-acting insulin rather than long-acting insulin) are well-documented. For example, “I injected 46 Units of the Wrong Insulin” by Ann Gann at www.diabeteshealth.com details an instance where the author, living with type 2 diabetes for over thirteen years and a diabetes trainer, mistakenly injects herself with 46 units of short-acting Apidra instead of long-acting Lantus. In this article, the author recognizes, “The flaw of a routine activity, however, is that it is so very routine: you go through the motions without thinking.” The author picked the wrong insulin vial while at a hotel on a speaking trip. Irl B. Hirsch, MD in “Insulin Packaging: A Medical Error Waiting to Happen” available at docnews.diabetesjournals.org refers to an instance where an elderly patient accidentally administers 32 units of insulin aspart, a short-acting insulin analog, instead of the ordered insulin glargine, a basal or long-acting insulin. The author comments that such incidents are becoming more common and are likely often caused by similar packaging for different medications.
Low blood sugar is the most common adverse effect associated with insulins. Symptoms associated with low blood sugar may be different from patient-to-patient and may change over time. Severe low blood sugar may cause seizures and be life-threatening.
Aside from the physical adverse effects of improper insulin administration, there may also be emotional effects, such as stress and panic. In instances where a parent administers insulin to a child, an insulin dosing mistake can result in feelings of guilt and embarrassment. In a document “What to Do: Gave the Wrong Dose of Insulin” provided by Texas Children's Hospital at www.texaschildrenshospital.org, it is acknowledged that “We all make mistakes in managing diabetes at some time.” Accordingly, there is a long-felt need to help patients self-administer the proper insulin.
Various techniques have been employed to help patients differentiate between long-acting insulin and short-acting insulin. In the past, short-acting insulins were a clear liquid and long-acting insulins were cloudy. In 2001, however, insulin glargine was introduced, which is a long-acting insulin that is clear rather than cloudy. Thus, it is no longer reliable to distinguish between long-acting and short-acting insulins based on the appearance of the insulin itself. Some companies, such as Eli Lilly and Company have introduced color differentiation systems to help differentiate between different insulin types. It is also known to provide insulin vials of different shapes for different insulin types.
The efficacy of such approaches have been limited. Dr. Hirsch submits that even “most providers who prescribe insulin are not familiar with the differences in appearance of various insulin vials and labels.” Dr. Hirsch chronicles a test where he asked thirteen general internists, all with numerous patients having type 2 diabetes, to identify three types of insulin with the labels on the vials removed. Only three of the thirteen internists knew each insulin type, while five were aware that glargine comes in a tall, skinny vial.
Patients have varying ability to distinguish between vial labels and shapes. For example, it is recognized in “The Effects of a Diabetes Education Program on Clinical Outcomes in Patients with Diabetes” by Stefan Cadag et al. (Diabetes, JUN 2009, vol. 58 no. Suppl. 1, p. A241-A242, ISSN: 0012-1797) that an intervention through a diabetes education program can be highly effective in improving glycemic control. However, not all patients attend diabetes education programs. Additionally, patients have varying degrees of cognitive skills. For example, some elderly patients may have trouble seeing differences between labels and vial shapes. Thus, it is desirable to provide to provide additional guidance in the administration of insulin and to reduce confusion as to which vial of insulin to use.
In one embodiment, a method of providing guidance using a portable hand-held electronic device in administration of a medicine by a patient is provided. The method includes acquiring image data of a first container of a first medicine prescribed to the patient and acquiring image data of a second container of a second medicine prescribed to the patient. The second container is different visually from the first container. The image data of the first container and the second container is stored in memory of the electronic device. On the portable hand-held electronic device, an instruction is processed to administer at least one of the first medicine and the second medicine to the patient. The stored image data is retrieved from memory corresponding to the at least one of the first medicine and the second medicine to be administered in the instruction. The retrieved image data is displayed on a display of the electronic device.
In another embodiment, a method of providing guidance using a portable hand-held electronic device in administration of a medicine by a patient is provided. The method includes providing a connection between the portable hand-held electronic device including mobile phone capabilities and a blood glucose meter. The portable hand-held electronic device acquires blood glucose information from the blood glucose meter. On the portable hand-held electronic device, an instruction is processed to administer at least one of a short-acting insulin and a long-acting insulin to the patient based, at least in part, on the blood glucose information. Vial image data is retrieved from memory corresponding to the at least one of the short-acting insulin and the long-acting insulin to be administered in the instruction. The retrieved vial image data is displayed on a display of the electronic device.
In another embodiment, a data and communications system for providing guidance in administration of a medicine by a patient includes a mobile device comprising a memory having a first vial image and a second vial image stored in the memory. The first vial image corresponds to a vial of short-acting insulin for administration by the patient and the second vial image corresponds to a vial of long-acting insulin for administration by the patient. The mobile device further includes a processor including logic that processes on the portable hand-held electronic device an instruction to administer at least one of the short-acting insulin and the long-acting insulin to the patient. At least one of the first vial image and the second vial image is retrieved from memory corresponding to the at least one of the short-acting insulin and the long-acting insulin to be administered in the instruction. The at least one of the first vial image and the second vial image corresponding to the at least one of the short-acting insulin and the long-acting insulin to be administered in the instruction is displayed on a display of the electronic device.
These and other advantages and features of the invention disclosed herein, will be made more apparent from the description, drawings and claims that follow.
The following detailed description of the embodiments of the present invention can be best understood when read in conjunction with the following drawings, where like structure is indicated with like reference numerals, and in which:
The following description of the preferred embodiment is merely exemplary in nature and is in no way intended to limit the invention or its application or uses.
Embodiments described herein generally relate to systems and methods that provide guidance in administering medicine to a patient. As used herein, the term “patient” refers to a person who is under medical care or treatment. In particular embodiments, the systems and methods are used to verify that the correct medicine is picked for administration to the patient using, in part, visual differences between different medicine containers. As one example, which will be described in greater detail below, a diabetic patient may typically self-administer his or her own insulin. Depending on a number of conditions, the patient may administer a long-acting insulin or a short-acting insulin. The systems and methods described herein may provide guidance that the proper insulin vial is chosen for administration of the proper insulin.
A flexible insulin therapy may include administration of long-acting insulin and short-acting insulin. As used herein, the terms “long-acting” and “basal” may be used interchangeably and the terms “short-acting,” “rapid-acting” and “bolus” may be used interchangeably. Long-acting insulin may be a background insulin and is typically administered when the patient is not eating. Long-acting insulin is usually present in the blood stream of the patient for long periods of time to assist in movement of glucose into cells. Short-acting insulin may be administered to bring down high blood sugar. Short-acting insulin may be administered, for example, to cover carbohydrates ingested during a meal.
In some embodiments, insulin administration may be adjusted based on, among other things, current blood glucose levels. The process of monitoring one's own blood glucose with a blood glucose meter is often referred to as self-monitoring of blood glucose (SMBG). In some cases, a portable hand-held blood glucose meter, among other devices, may be used in SMBG, which may be a relatively small, battery-operated device.
To test glucose with a blood glucose meter, a small sample of blood may be placed on a disposable test strip. The portable hand-held blood glucose meter may include a strip port that receives the disposable test strip. The test strip may be coated with chemicals (glucose oxidase, dehydrogenase, or hexokinase) that combine with glucose in blood. The portable hand-held blood glucose meter then measures concentration of glucose in the blood sample. The portable hand-held blood glucose meter then displays the glucose concentration as a number (or glucose measurement value). This glucose measurement value may be used in selecting whether to administer a long-acting insulin, a short-acting insulin or both and the dosage.
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A continuous glucose monitor 54 may be used to obtain time-resolved data and communicate the data to the mobile device 14 to identify fluctuations and trends that may otherwise go unnoticed with spot monitoring of blood glucose levels and standard HbA1c tests, such as low overnight glucose levels, high blood glucose levels between meals, early morning spikes in blood glucose levels, and how diet and physical activity affect blood glucose along with the effect of therapy changes. An example of a continuous glucose monitor 54 is described in U.S. Pat. No. 7,389,133, which is hereby incorporated by reference.
In some embodiments, the patient may have an implanted or externally worn infusion device 56 that is configured to deliver a glucose-lowering drug, e.g., insulin, to the patient. In such cases, the liquid infusion device 56 may include a communication circuit that may be configured for connection with mobile device 14, the blood glucose meter 10 and/or the portable computer 16. In embodiments wherein the infusion device 56 is an externally-worn liquid infusion device, the communication circuit may be configured for hard wire communications and/or wireless communications with any of the devices 10, 14 and 16. In other embodiments wherein the liquid infusion device 56 is an implanted infusion device, communications between the device 56 and any of the devices 10, 14 and 16 may generally be carried out via the wireless communication link. Liquid infusion information, e.g., insulin delivery information, may be automatically transferred from the liquid infusion device 56 to the blood glucose meter 10, to a processor of the mobile device 14 and/or to a processor portable computer 16. As used herein, the term “insulin delivery information” includes any information relating to delivery of insulin to the patient including, for example, but not limited to, insulin delivery type, e.g., basal, correction bolus or meal compensation bolus, insulin quantity or amount, insulin delivery pattern, e.g., single or multiple delivery events, and insulin delivery rates (e.g., speed of delivery of the one or more insulin delivery events). In embodiments that do not include a liquid infusion device 56, an insulin or another blood glucose lowering drug may be instead delivered to the patient via manual injection or other manual administering technique. The insulin delivery information may alternatively be manually provided to the mobile device 14 via the user interface 24, and may alternatively or additionally be manually provided to the portable computer 16.
In some embodiments, additional monitoring devices 18 may be used to obtain health-related data. Such monitoring devices 18 may include devices for determining blood pressure, weight, etc. The monitoring devices 18 may communicate such data to the mobile device 14.
In some embodiments, the mobile device 14 may communicate with a personal computer 62, for example, running diabetes management software 64. The diabetes management software 64 may be used to collect self-care data and analyze results using graphs and charts for continuous improvement of diabetes management. Customized reports may be generated related to blood glucose, ketones, blood pressure, cholesterol, weight, carbohydrates and exercise, as examples.
The mobile device 14 may also be configured to utilize a diabetes management and collection system 66 via the Internet 68 using services provided by phone provider 20. For example, web-based applications may be accessible over the Internet. Charts, reports and other data may be communicated over the Internet 68 to and from the mobile device 14 for assistance in diabetes management. In some embodiments, clinicians can use diabetes software to evaluate patient diabetes data for therapy results, for example, sent over the Internet using the mobile device 14. An example of diabetes software is disclosed in U.S. patent application Ser. No. 11/999,968 filed Dec. 7, 2007 entitled “Method and System for Setting Time Block,” the details of which are hereby incorporated by reference in their entirety.
The data and communications system 12 may provide insulin delivery information to the patient and provide guidance that the proper insulin vial is chosen for administration. The data and communications system 12 may be used to determine any of insulin delivery type, e.g., basal, correction bolus or meal compensation bolus, insulin quantity or amount (e.g., in international units or I.U.), insulin delivery pattern, e.g., single or multiple delivery events, and insulin delivery rates (e.g., speed of delivery of the one or more insulin delivery events). In instances where a specific type of insulin is specified (e.g., between short-acting and long-acting insulin), the data and communications system 12 may provide an output to aid the patient in selecting the proper vial from which to draw the insulin for self-administration.
As one illustrative example of data collection, the mobile device 14 may have memory 33 having at least one algorithm stored therein that is executable by the processor 35 of the mobile device to present instructions to the patient via the display 26, a speaker configured to present audible instructions to the patient, etc (see
The mobile device 14 may be programmed with one or more algorithms that are executable by the processor 35 of the mobile device to guide a patient through a patient information collection time period. Initially, the patient information entered into the mobile device 14 may be stored in the memory 33 of the mobile device. The patient information may be subsequently transferred or copied to the diabetes management and collection system 66 for storage in a database, e.g., via the Internet 68 and/or the telephone network 20. In some embodiments, a health care professional may access the patient information stored in the database of the diabetes management and collection system 66 to analyze this data from a remote location and design a diabetes therapy for the patient, or modify an existing diabetes therapy, that is based on this analysis.
While the mobile device 14 may be programmed to guide a patient through a patient information collection time period, other devices of the data and communications system 12 may be programmed to guide the patient through the patient information collection. For example, any one or more of the portable computer 16, personal computer 62, blood glucose meter 10 and diabetes management and collection system 66 may be by used to guide the patient through the patient information collection and/or store the patient information in memory. Various methods of patient information collection is disclosed in U.S. patent application Ser. No. 11/424,757, already incorporated by reference.
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It should be understood that the method 90 may be modified to require the patient to enter more or less meal-related information, and examples of additional meal information that may be required to be entered by the patient include, but are not limited to, a meal speed value, corresponding to the speed at which the meal is consumed, a total glycemic index of the meal, and meal size in terms of fat content, carbohydrate content and protein content. The term “glycemic index” is defined for purposes of this document as a parameter that ranks meals and snacks by the speed at which the meals or snacks cause the patient's blood sugar to rise. Thus, for example, a meal or snack having a low glycemic index produces a gradual rise in blood sugar whereas a meal or snack having a high glycemic index produces a fast rise in blood sugar. One exemplary measure of total glycemic index may be, but should not be limited to, the ratio of carbohydrates absorbed from the meal and a reference value, e.g., derived from pure sugar or white bread, over a specified time period, e.g., 2 hours. With any of the meal size or meal speed information, it will be understood that method 90 may be configured to require a patient to enter absolute estimates as illustrated e.g., “small,” or may alternatively be configured to require the patient to enter such information in relative terms, e.g., “smaller than normal.”
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The lists of image data files and associate images may be regional and/or country specific. The lists of image data files may be updated to include new insulin products. In some embodiments, multiple images may be associated with a particular insulin product, for example, cartons, vials, insulin pens, cartridges, etc.
All documents cited herein are incorporated herein by reference and the citation of any document is not to be construed as an admission that it is prior art with respect to the present invention. To the extent that any meaning or definition of a term in this written document conflicts with any meaning or definition of the term in a document incorporated by reference, the meaning or definition assigned to the term in this written document shall govern.
The above description and drawings are only to be considered illustrative of exemplary embodiments, which achieve the features and advantages of the present invention. Modification and substitutions to specific process steps, system, and setup can be made without departing from the spirit and scope of the present invention. Accordingly, the invention is not to be considered as being limited by the foregoing description and drawings, but is only limited by the scope of the appended claims.
