System and method for improved diabetes data management, and method of use
Abstract
Problem to be solved.To provide a "pay for result" model in which a payer pays only for strips actually used in a diagnostic test device and a drug delivery device. .. Methods, devices, and systems for disease management that use diagnostic test devices (eg, glucose meters) and drug delivery devices (eg, insulin delivery devices) to send data to repositories in real time and automatically. Is provided. Analyze repository data to determine information such as actual test strip use, out-of-specification patient health parameters, compliance with tests and drug delivery, patient profiles or stakeholders to receive promotional items or incentives can do. Connected meters and drug delivery devices and repository data analysis are also used to correlate diagnostic tests with meal times based on the timing of treatment interventions performed by individuals. .. [Selection diagram] Fig. 3

Term
Projected expiry 27 June 2032.
- Priority
- Filed
- Published
- Today
- Projected expiry
16 claims: 4 independent, 12 dependent
- 1テストストリップの使用を監視する方法であって、 それぞれの患者について、1日当たりの推奨テストの数、および供給者および保険業者の一方を介して前記患者に割り振られたテストストリップの数のうちの少なくとも一方を含む、患者に関するテスト用データを、リポジトリ内に記憶することと、 測定されたグルコースレベルを含むテスト結果を、ユーザの介入なしに、血糖計から前記リポジトリに自動的に送信することと、 前記患者によって実際に使用されたテストストリップの数、および選択された期間内に使用されない、割り振られたテストストリップの数のうちの少なくとも一方を決定するために、前記患者のうちの少なくとも選択された1人について、前記リポジトリ内に記憶されている前記テスト用データと前記テスト結果を比較することと を含むことを特徴とする方法。
- 2前記患者によって実際に使用されたテストストリップの数が前記患者に割り振られたテストストリップの数の選択された比率である場合、テストストリップに関する処方を自動的に補充することをさらに含むことを特徴とする請求項1に記載の方法。
- 3前記患者がいつテストストリップを使い果たすかの推定を生成すること、および、前記患者に割り振られた、選択された数のテストストリップが未使用のままであると決定されたとき、前記患者に、より以上のテストストリップを自動的に送ることをさらに含むことを特徴とする請求項1に記載の方法。
- 4前記患者によって実際に使用されたテストストリップの数に基づいて、保険業者およびヘルスケア支払者のうちの少なくとも一方に、テストストリップに対して支払い請求することをさらに含むことを特徴とする請求項1に記載の方法。
- 51日当たりの前記患者の対応する数の推奨テストを実施する前記患者の遵守と、前記患者の対応するテスト結果に基づく選択されたグルコースレベルとに基づいて、選択されたテスト慣行のうちの少なくとも1つを有する前記患者のうちの選択された1人を識別するために、前記リポジトリ内の前記テスト用データおよび前記テスト結果を解析することと、 促進物、教育的情報、および奨励金のうちの少なくとも1つを前記患者のうちの前記選択された1人に送信することと をさらに含むことを特徴とする請求項1に記載の方法。
- 6前記送信することは、 前記患者の対応するテスト結果に基づいて、選択された健康プロファイルのうちの少なくとも1つを有する前記患者のうちの選択された1人を識別するために、前記リポジトリ内の前記テスト用データおよび前記テスト結果を解析することと、 新しい糖尿病管理製品にとっての潜在的な消費者として前記患者のうちの前記選択された1人に送信するために、広告をベンダに販売することと をさらに含むことを特徴とする請求項5に記載の方法。
- 7前記リポジトリは、前記血糖計に関するメータ較正データ記憶し、 前記血糖計が故障しているかどうか判定するために、前記テスト結果および前記メータ較正データを解析することと、 前記血糖計が故障していると決定されたとき警報を送信することと をさらに含むことを特徴とする請求項5に記載の方法。
- 8前記テスト用データは、テストストリップ製造者、テストストリップ有効期限、ロット番号、較正データ、製造者識別、および配布国または地域を含むロジスティクス情報のデータのうちの少なくとも1つをさらに含み、 前記テストストリップのいずれかに欠陥があるかどうか判定するために、および前記リポジトリに記憶された前記テスト結果前記テスト用データを解析することと、 前記テストストリップのいずれかに欠陥があると決定されたとき警報を送信することと をさらに含むことを特徴とする請求項5に記載の方法。
- 9診断データを使用する方法であって、 治療データと、様々な治療イベントがいつ患者に施されたかに関する、対応するタイムスタンプとを受信することと、 診断テストデータと、診断テストがいつ前記患者に施されたかに関する、対応するタイムスタンプとを受信することと、 前記患者がいつ食事をするか、いつ眠るか、夜間テストがいつ前記患者に施されるかのうちの少なくとも2つに関するそれぞれのタイムスタンプを含むパラメータを受信することと、 ある治療イベントを、患者に施されたテストと、かつ食事時間、就寝時間、および夜間テストのうちの少なくとも1つと関連付けるために、前記治療データタイムスタンプと、前記診断テストデータタイムスタンプと、前記患者がいつ食事をするか、いつ眠るか、夜間テストがいつ患者に施されるかのうちの少なくとも2つに関するそれぞれのタイムスタンプとを解析することと を含むことを特徴とする方法。
- 10前記解析することは、 そのタイムスタンプがその日の1回目の食事の前である場合、治療イベントをその日の前記1回目の食事に関連付けることと、 そのタイムスタンプがその日の前記1回目の食事の後、かつ2回目の食事の前である場合、前記治療イベントをその日の前記2回目の食事に関連付けることと、 そのタイムスタンプがその日の前記2回目の食事の後、かつ3回目の食事の前である場合、前記治療イベントをその日の前記3回目の食事に関連付けることと、 そのタイムスタンプがその日の前記3回目の食事の後、かつ就寝時間の前である場合、前記治療イベントを就寝時間に関連付けることと を含む、前記治療イベントに対応する前記タイムスタンプを割り振ることを含むことを特徴とする請求項9に記載の方法。
- 11治療データと、様々な治療イベントがいつ患者に施されたかに関する、対応するタイムスタンプとを受信することと、 診断テストデータと、診断テストがいつ前記患者に施されたかに関する、対応するタイムスタンプとを受信することと、 1日当たり食される食事の典型的な数に対応するパラメータを受信することと、 1日を複数の食事時間に分割し、前記治療データタイムスタンプを食事時間に対して分類するように、前記治療データタイムスタンプおよび前記診断テストデータタイムスタンプが1日当たり食される食事の前記数に比べてどのようにクラスタ化するか判定するために、前記治療データタイムスタンプと、前記診断テストデータタイムスタンプと、1日当たり食される食事の前記数とを解析することと を含むことを特徴とする方法。
- 12前記解析することは、1日を複数の食事時間に分割するように、前記治療データタイムスタンプおよび前記診断テストデータタイムスタンプが1日当たり食される食事の前記数に比べてどのようにクラスタ化するか判定するために、平均時間と、前記平均時間の周りでの信頼区間および変動のうちの少なくとも一方の選択された尺度とを決定することを使用することを特徴とする請求項11に記載の方法。
- 13前記解析することは、 選択された数の、治療イベント前A分以下である前記診断テストに対応する前記タイムスタンプを「食前」として分類することと、 選択された数の、前記治療イベント後B分以上、かつ選択された数の、前記治療イベント後C分以下である前記診断テストに対応する前記タイムスタンプを「食後」として分類することと、 選択された数の、前記治療イベント前D分以下、かつ前の治療イベント後C分以上である前記診断テストに対応する前記タイムスタンプを「食前」として分類することを含み、 A、B、C、Dが整数であり、A<B<CかつA<D<Bである、1組のタイミング閾値を適用することと を含むことを特徴とする請求項9または請求項11に記載の方法。
- 14前記タイムスタンプもまたデータを含み、 食前または食後としての前記治療イベントの前記分類の精度に関して、フィードバックデータを患者から受信することと、 前記データと、前記治療データおよび前記診断テストデータに対応するタイムスタンプとを解析し、連続する解析時に前記フィードバックを使用し、食前または食後としての前記治療イベントの前記分類を改善する反復学習アルゴリズムを使用することと をさらに含むことを特徴とする請求項9または請求項11に記載の方法。
- 15前記治療イベントは、インスリン注入であり、前記診断テストは、血糖テストであることを特徴とする請求項9または請求項11に記載の方法。
- 16前記解析することが、血糖計、および血糖計と2方向通信するリポジトリのうちの一方内のプログラム型処理デバイスを介して実施されることを特徴とする請求項9または請求項11に記載の方法。
Independent claims16
89 paragraphs, as filed
The present invention generally relates to improved methods, devices, and systems for disease management. More specifically, the present invention may improve real-time communication of data between devices (glucose meters, insulin delivery devices) and repositories, and disease management, resulting in cost savings for disease management stakeholders. Regarding analysis of repository data to obtain information.
The present application claims the benefit of 35/784760 US Pat. No. 6,037,600, filed March 23, 2006, under 35 USC 119 (e).
Figure 1 shows an existing system 10 for disease management. For convenience, the following abbreviations shall be used herein. BGM glucose meter DM Diabetes Management DMC Disease Management Company DMD Diabetes Management Data WM Wireless BGM
As shown in FIG. 1, patient 12 performs blood glucose monitoring (eg, using BGM18 with a lancet and test strip, or a continuous meter) and, if necessary (eg, syringe, pen, etc.). Or inject insulin (via pump 20). BGM and insulin infusions are generally manually recorded in notebook 22 by the patient or his or her caregiver for sharing with a healthcare provider such as Doctor 14 or Disease Management Company 16. This information is generally shared via a telephone (eg, telephones 26, 28, 32), a computer (eg, computers 24 and 30), or directly through the person during an outpatient visit. This information can also include information on regular diets, exercise, and other factors that affect the outcome of diabetes management. Unfortunately, this information is not validated in a reliable and cohesive manner that would be useful to the patient's healthcare team in facilitating optimal diabetes management, and is often not recorded, collected, or managed.
Continuing to refer to Figure 1, diabetes management data such as blood glucose tests and insulin intake can also be recorded using a personal computer (PC) 24 instead of handwritten recording 22 or using a device (eg, software interface). , Blood glucose meter 18 or insulin delivery pen 20) can also be uploaded to the patient's PC24. However, conventional communication interfaces are inconvenient because in order to upload data from BGM18, patient 12 must acquire a communication interface such as specialized modem and / or installation software on PC24. In addition, in such a PC interface for diabetes data management, other stakeholders in diabetes management and care, namely doctors and care, as shown by the optional line shown by the dashed line in Figure 1. It is not always possible to share the entered data with other healthcare providers 14, insurers, or disease management companies (DMCs) 16 typically requested by employers or insurance companies. If diabetes management data from patient 14 can be sent to healthcare team member PC30, that information is generally not recorded in a comprehensive manner that guarantees the integrity, accuracy, and timeliness of the data. For example, patient 14 very often cannot test, or write, enter, or upload blood glucose test results or insulin infusions in an easy-to-understand manner, which is not possible for healthcare team members 30 and 16. Complete information remains and healthcare team members are unable to identify opportunities or events to teach in diabetes management or respond in real time.
Similarly, special cradle such as GlucoMON by Diabetech in Dallas, Texas is currently available to safely retrieve data from patient 12 to others. Diabetech builds this device to send blood glucose test results to selected people, typically via mobile phones, pagers, or emails, as directed by Patient 12 or his legal guardian. To manage. However, this data is only reported to selected people and is not collected and managed in a comprehensive manner. Therefore, this system requires user 12 to acquire a secondary device and connect to that person's BGM18. Therefore, there is a need for an integrated device for monitoring blood glucose levels and reporting them to other stakeholders in diabetes management and care.
Mobile phones combined with diabetes data management capabilities have been proposed, but it's not surprising in an era when personal electronic devices are becoming more and more indispensable. For people with chronic illnesses such as diabetes, the technological convergence of healthcare and personal electronics is a drug, meter, pump, infusion, especially for people with chronic illnesses that require significant self-management. It is becoming more and more reasonable to manage the use and the need to carefully track and document important health data.
Several healthcare companies are developing smarter, more convenient surveillance devices, using telecommunications technology to create versatile portable devices for patient use. One of these companies is HealthPia, a telemedicine venture based in Newark, NJ. In America, he developed a mobile phone that also works as a blood glucose monitor and features a pedometer. An embedded electronic biosensor in the battery pack allows the mobile phone to have a glucose meter function. This sensor reads the blood glucose level from the strip. The data is then uploaded to the mobile phone display. This phone can be programmed to immediately send information to the healthcare provider 14, parent, or guardian. In addition, movement and movement can be monitored with a built-in pedometer. The phone can be programmed to send an alert to the caregiver or clinician via short message service if there is no pedometer reading for a pre-programmed length of time. The care manager can call back to check if patient 12 is okay, and if there is no response, can initiate a preconfigured emergency procedure. This function can be inherently useful in detecting an insulin response or severe hypoglycemia in diabetic patients 12. Diabetes The biggest advantage of the Phone is its alarm function, which allows the doctor to set specific parameters. For example, if the phone is continuously reporting hyperglycemia, the doctor can respond in real time.
Other diabetes mobile phone projects include a study at Oxford University in the United Kingdom to test a system similar to that of HealthPia America. Since 2002, UK patients with diabetes 12 have been on Sweet Talk, a messaging service that reminds other ventures of taking insulin via mobile phones and provides general education about life with diabetes. You can register. In addition, in 2003, IBM announced that it could use its "Bluetooth" short-range wireless technology to intercept the heart rate of a person 12 and send it to a mobile phone.
At the ITU Telecom Asia 2004 show in South Korea, LG Electronics presented the new handset KP8400. The KP8400 is designed for diabetes and allows you to perform blood glucose level tests just as a dedicated device does. User 12 places a piece of test strip in a sensor located in the battery pack of the phone, places a drop of blood on the edge of the piece of paper, and then obtains a reading from the phone. The readings can then be uploaded to an online database for later retrieval. LG Electronics is strategically partnering with HealthPia Co., LTD to implement the KP8400.
These new, proposed electronic devices for diabetes management will be widely adopted and will result in better self-care for patients 12, or clinicians striving to manage new streams of information14. Whether it will only add more work to the patient will be a central question when this new cutting-edge technology in electronic medicine is sought. For example, the data reported by one of these emergency mobile phone technologies can be used for real-time test results, verification of test strip lot numbers and use, or other such as mealtime events and therapeutic interventions (eg, insulin infusions). It does not seem to be managed in a comprehensive manner that can be associated with the information in.
Moreover, what is highly overlooked is the value to relatively recent stakeholders in DM's business. Therefore, there is a need for business models, methods, and equipment that maximize the value of DMDs collected for various stakeholders such as disease management companies 16, insurers, and healthcare networks.
As mentioned above, the illness management company 16 is generally commissioned by the patient's insurer or employer to provide the patient 12 with educational support for his or her illness. The DMC obtains required data such as prescription and visits to healthcare providers 14, as well as other data such as BG measurements, insulin dosages, diets, and exercise. Most of this information is collected from patient 12 via telephone (eg, telephones 26, 28, 32), which is problematic for several reasons. For whatever reason, patients are often completely representative of their healthcare provider 14 and DMC16 about their DM lifestyle (eg, regular diet, exercise, BG tests, and drugs with insulin). Not sincere. Some reasons are improper education, indifference, apathy, financial barriers to diabetes self-management, unfamiliarity with testing and using data interface equipment, or impaired equipment or testing techniques (eg,). Insufficient timing regarding meal time).
Therefore, DMC16 and other third parties (eg, insurance companies, Medicare, Medicaid, HMO, etc.) take care of themselves better in patient 12, and also manage diabetes. There is a need for a diabetes data management system that can be motivated to improve results in a way. For example, there is a need for a system that can monitor and validate the actual blood glucose monitoring practices of patients. DMC16 is then economical by giving patients who are making progress in managing diabetes a test strip and / or blood glucose monitor at a nominal cost or free of charge, or by abandoning joint payments. Barriers can be removed.
Currently, reimbursement for diabetes test supplies by third parties (eg, insurance companies, Medicare, Medicaid, HMO, etc.) is based on a model that covers a specific number of BGM test strips depending on the patient's condition. (For example, a person with diabetes 12 who needs insulin infusion to help manage diabetes may have a coverage of 60 BGM test strips per month (2 per day). People with diabetes 12 who have or use oral medications to help manage diabetes may have a coverage of 30 BGM test strips per month (1 per day) ). In this model, supplementation with the BGM test strip prescription only indicates the use of the BGM test strip. However, this is a) patient 12 actually tested his or her blood glucose using a BGM test strip, b) the test was done at the right time, c) the result of any test done, Does not provide any objective evidence. In some circumstances, Patient 12 may "stockpile" test strips and provide them to other family members or friends who do not have equivalent insurance coverage for their needs. In these cases, the third party payer is paying for the test supplies that are not being used or are not being used properly. In this model, for example, mail-order supply companies, and ultimately BGM test strip manufacturers, will benefit. This is because all test strips delivered to the patient are paid by a third party, regardless of the patient's actual use. Therefore, there is a need for a "pay for results" model in which the payer pays only for the strips actually used.
<p> Aspects of the exemplary embodiments of the invention address at least the problems and / or drawbacks described above and provide at least the advantages described herein.</p>
<p> For example, by automating the sharing of collected data among other stakeholders, an exemplary embodiment of a DM system that facilitates the patient's involvement in DMD reporting is provided. Preferably, the patient is not involved in the automated data movement (for example, connecting the background music device to a computer or other communication device without even having to press the "send" button to upload the BG measurement data to stakeholders. There is no option that requires more user effort).</p><p> An exemplary embodiment of DM is provided that improves patient compliance with respect to records and information sharing with healthcare providers. For example, accurately collected data reflects the patient's situation and prevents failure to test or report on events of interest to stakeholders, use of poor test strips, and so on.</p><p> An exemplary embodiment of a DM system business model is provided that emphasizes the use of data by the payer as well as the use of the data by the patient and emphasizes the value of the DMD for the device used to collect the data.</p><p> Real-time reporting of event data for a stakeholder is provided by an exemplary embodiment of the invention. Transactions are tuned for use (for example, uploads are 100% real-time, depending on which stakeholders are included, but retrieves and access are not real-time).</p><p> An exemplary embodiment of a BGM device is simplified to be a display device, and its analysis capabilities for generating average and trend data are moved to the repository level. Therefore, the device is less complex and offers some benefits (eg, reduced development time and therefore time to sale, and reduced complexity, thereby reducing the potential for harm). In addition, the simplified BGM device increases the usable life of the device. This is because software "upgrades" are performed at the repository level rather than at the device level. These simplified devices allow device firmware upgrades to be performed wirelessly, eliminating the need for frequent replacement due to upgrades. For example, instead of upgrading memory modules, the device can be equipped with FLASH memory to receive upgrades from the repository over the communication network.</p><p> An exemplary embodiment of the present invention replaces the current refund model for test supplies with a pay for results model of doing business and realizes a number of benefits.</p><p> An exemplary embodiment of the invention provides a business model, method, and device that maximizes the value of DMD collected for various stakeholders such as disease management companies, insurers, and healthcare networks. provide.</p><p> According to an exemplary embodiment of the invention, an insulin delivery device comprising at least one of a syringe, a microneedle, a pump, and an insulin pen configured to deliver insulin, and an insulin delivery device. Activate the RFID tag connected to the insulin delivery device and to store the insulin delivery device data, including the insulin type delivered via the insulin delivery device, to transmit the insulin delivery device identification number. And at least send the RFID reader for collecting insulin delivery device data and the data about insulin delivered by the insulin delivery device to the repository automatically and virtually in real time without user involvement. To provide an insulin delivery system with a blood glucose meter with a wireless communication circuit configured to communicate wirelessly with the repository.</p><p> According to another exemplary embodiment of the invention, the method of monitoring the use of test strips is for each patient, the number of recommended tests per day, and to the patient via either the supplier or the insurer. Store test data for patients, including at least one of the allocated test strips, in the repository, and store test results, including measured glucose levels, from the glucose meter without user intervention. To determine at least one of the number of test strips actually used by the patient and the number of allocated test strips that will not be used within the selected time period. Includes comparing test data with test results stored in the repository for at least one selected patient.</p><p> According to an exemplary embodiment of the invention, methods of using diagnostic data include receiving treatment data and corresponding time stamps as to when various treatment events were given to the patient, with diagnostic test data. Regarding at least two of when the patient eats, sleeps, and when the night test is given to the patient, receiving a corresponding time stamp and when the diagnostic test was given to the patient. Receiving parameters containing their respective time stamps, with treatment data time stamps, to associate treatment events with the tests performed on the patient and at least one of meal time, bedtime, and nighttime tests. Includes analyzing the diagnostic test data time stamps and their respective time stamps for at least two of when the patient eats, sleeps, and when the night test is given to the patient. Alternatively, this method receives parameters corresponding to the typical number of meals eaten per day, then divides the day into multiple meal times and sets the treatment data timestamp to the meal times. Treatment data time stamps and diagnostic test data time stamps to determine how the treatment data time stamps and diagnostic test data time stamps cluster relative to the number of meals eaten per day. It can include analyzing the stamp and the number of meals eaten per day.</p><p> The above and other objectives, features, and advantages of some exemplary embodiments of the invention will become more apparent from the following detailed description when read in conjunction with the accompanying drawings.</p><p> Throughout the drawings, the same drawing reference numbers are understood to refer to the same elements, features, and structures.</p>
<figref num="1">It is a diagram of the current flow of data and information between a patient and his or her disease management device and stakeholders.</figref><figref num="2">It is a diagram of stakeholders in disease management and a typical flow of information.</figref><figref num="3">FIG. 5 is a diagram of wireless connectivity and RF communication path options for improving the flow of data and information between a patient and his or her disease management device and stakeholders and repositories, according to an exemplary embodiment of the invention. ..</figref><figref num="4">It is a block diagram of the repository according to an exemplary embodiment of the present invention.</figref><figref num="5A">FIG. 5 is a perspective view of a wireless meter constructed according to an exemplary embodiment of the present invention.</figref><figref num="5B">FIG. 5 is a perspective view of a wireless meter constructed according to an exemplary embodiment of the present invention.</figref><figref num="6">It is a block diagram of a wireless meter constructed according to an exemplary embodiment of the present invention.</figref><figref num="7">FIG. 6 is a block diagram of a wireless meter using a wireless USB connection according to an exemplary embodiment of the present invention.</figref><figref num="8">FIG. 6 is a block diagram of a wireless meter using a WiFi or WiMax connection according to an exemplary embodiment of the present invention.</figref><figref num="9">FIG. 6 is a block diagram of a wireless meter using a Bluetooth or ZigBee connection according to an exemplary embodiment of the present invention.</figref><figref num="10A">FIG. 6 is a block diagram of a wireless meter using a built-in for sustainability according to an exemplary embodiment of the present invention.</figref><figref num="10B">FIG. 6 is a block diagram of a wireless meter using a cell modem attachment for connection according to an exemplary embodiment of the present invention.</figref><figref num="11A">FIG. 3 is a perspective view of a base station and a meter according to an exemplary embodiment of the present invention.</figref><figref num="11B">It is a top view of a base station and a meter according to an exemplary embodiment of the present invention.</figref><figref num="11C">It is a side view of a base station and a meter according to an exemplary embodiment of the present invention.</figref><figref num="11D">FIG. 3 is a diagram of a base station and a meter according to an exemplary embodiment of the present invention, that is, a perspective view of the meter only.</figref><figref num="11E">FIG. 6 is a diagram of a base station and a meter according to an exemplary embodiment of the present invention, that is, a side view of the meter showing a port for connecting to the base station.</figref><figref num="11F">FIG. 6 is a diagram of a base station and a meter according to an exemplary embodiment of the invention, i.e. a block diagram of a docking station component and a meter component having corresponding interfaces for connecting to each other.</figref><figref num="12A">FIG. 6 is a block diagram of a base station or docking station and meter that can be connected to a repository directly or through a device according to an exemplary embodiment of the invention.</figref><figref num="12B">FIG. 6 is a block diagram of a base station or docking station and meter that can be connected to a repository directly or through a device according to an exemplary embodiment of the invention.</figref><figref num="13A">It is a perspective view of the BGM in the mobile phone according to the exemplary embodiment of the present invention.</figref><figref num="13B">It is a side view of the BGM in the mobile phone according to the exemplary embodiment of the present invention.</figref><figref num="13C">It is a rear view of the BGM in the mobile phone according to the exemplary embodiment of the present invention.</figref><figref num="14">It is a block diagram which shows the connection of BGM in a mobile phone by an exemplary embodiment of this invention.</figref><figref num="15A">It is a figure of the connection type syringe by the exemplary embodiment of this invention.</figref><figref num="15B">It is a figure of the connection type syringe by the exemplary embodiment of this invention.</figref><figref num="15C">It is a figure of the connection type syringe by the exemplary embodiment of this invention.</figref><figref num="15D">It is a figure of the connection type syringe by the exemplary embodiment of this invention.</figref><figref num="16A">It is a figure of the connection type pen by the exemplary embodiment of this invention.</figref><figref num="16B">It is a figure of the connection type pen by the exemplary embodiment of this invention.</figref><figref num="16C">It is a figure of the connection type pen by the exemplary embodiment of this invention.</figref><figref num="16D">It is a figure of the connection type pen by the exemplary embodiment of this invention.</figref><figref num="16E">It is a figure of the connection type pen by the exemplary embodiment of this invention.</figref><figref num="17">It is a block diagram which shows the connection of the pen or the syringe by the exemplary embodiment of this invention.</figref><figref num="18A">FIG. 5 is a flow chart relating to the use of test data by DMC according to an exemplary embodiment of the present invention.</figref><figref num="18B">FIG. 5 is a flow chart relating to the use of test data by DMC according to an exemplary embodiment of the present invention.</figref><figref num="19">It is a flow chart which shows the use of the test data for controlling a test strip replenishment, a promotional material, etc. by an exemplary embodiment of the present invention.</figref><figref num="20">FIG. 5 is a flow diagram illustrating the use of test data to enroll patients in monthly service connection contracts and manage incentives disbursements, etc., according to an exemplary embodiment of the invention.</figref><figref num="21A">FIG. 5 is a front view of a blood glucose monitor including a radio frequency identification transponder according to an exemplary embodiment of the present invention.</figref><figref num="21B">FIG. 5 is a rear view of a blood glucose monitor including a radio frequency identification transponder according to an exemplary embodiment of the present invention.</figref><figref num="22">FIG. 5 is a diagram of a blood glucose test strip container having a radio frequency identification transponder integrated with an outer label according to an exemplary embodiment of the present invention.</figref><figref num="23">FIG. 5 is a diagram of a blood glucose test strip container having a radio frequency identification transponder integrated with a cap according to an exemplary embodiment of the present invention.</figref><figref num="24">FIG. 5 is a diagram of a blood glucose test strip having a radio frequency identification transponder as part of the test strip according to an exemplary embodiment of the invention.</figref><figref num="25">FIG. 5 is a diagram of a system in which a blood glucose monitor receives data from a test strip container and a test strip according to an exemplary embodiment of the invention.</figref><figref num="26">FIG. 6 is a process flow diagram relating to a parameter-based approach for grading diagnostic test data using treatment time, according to an exemplary embodiment of the invention.</figref><figref num="27">FIG. 6 is a process flow diagram relating to an analysis-based method for grading diagnostic test data using treatment time, according to an exemplary embodiment of the invention.</figref><figref num="28">FIG. 5 is a process flow diagram for an analysis-based method with a feedback loop for grading diagnostic test data using treatment time, according to an exemplary embodiment of the invention.</figref><figref num="29">It is a diagram of the benefits of connectivity and value-added information provided by exemplary embodiments of the invention in the context of patient and disease management as a whole.</figref><figref num="30">It is a diagram of the benefits of connectivity and value-added information provided by exemplary embodiments of the invention in the context of patient and disease management as a whole.</figref><figref num="31">It is a diagram of the benefits of connectivity and value-added information provided by exemplary embodiments of the invention in the context of patient and disease management as a whole.</figref><figref num="32">FIG. 5 is a diagram of current cash flows among DM stakeholders that can be improved by exemplary embodiments of the invention in the context of patient and disease management as a whole.</figref><figref num="33">FIG. 5 is a diagram of current cash flows among DM stakeholders that can be improved by exemplary embodiments of the invention in the context of patient and disease management as a whole.</figref><figref num="34">FIG. 5 is a diagram of current cash flows among DM stakeholders that can be improved by exemplary embodiments of the invention in the context of patient and disease management as a whole.</figref><figref num="35">FIG. 5 is a diagram of current cash flows among DM stakeholders that can be improved by exemplary embodiments of the invention in the context of patient and disease management as a whole.</figref><figref num="36">FIG. 5 is a diagram of current cash flows among DM stakeholders that can be improved by exemplary embodiments of the invention in the context of patient and disease management as a whole.</figref><figref num="37">FIG. 5 is a diagram of current cash flows among DM stakeholders that can be improved by exemplary embodiments of the invention in the context of patient and disease management as a whole.</figref><figref num="38">It is a diagram of an improvement over the current cash flow among DM stakeholders brought about by the model paying for the results, which is carried out according to an exemplary embodiment of the present invention.</figref><figref num="39">It is a diagram of an improvement over the current cash flow among DM stakeholders brought about by the model paying for the results, which is carried out according to an exemplary embodiment of the present invention.</figref><figref num="40">It is a diagram of an improvement over the current cash flow among DM stakeholders brought about by the model paying for the results, which is carried out according to an exemplary embodiment of the present invention.</figref><figref num="41A">FIG. 5 is a diagram of a blood glucose monitor having a display message according to an exemplary embodiment of the present invention.</figref><figref num="41B">FIG. 5 is a diagram of a blood glucose monitor having a display message according to an exemplary embodiment of the present invention.</figref><figref num="41C">FIG. 5 is a diagram of a blood glucose monitor having a display message according to an exemplary embodiment of the present invention.</figref><figref num="41D">FIG. 5 is a diagram of a blood glucose monitor having a display message according to an exemplary embodiment of the present invention.</figref><figref num="42">FIG. 5 is a diagram of a display screen generated for viewing through a computing device of a disease management stakeholder, according to an exemplary embodiment of the present invention.</figref><figref num="43">FIG. 5 is a diagram of a display screen generated for viewing through a computing device of a disease management stakeholder, according to an exemplary embodiment of the present invention.</figref>
What is revealed in this description, such as detailed structure and elements, is provided to aid in a comprehensive understanding of embodiments of the present invention. Accordingly, one of ordinary skill in the art will appreciate that various modifications and modifications of the embodiments described herein can be made without departing from the scope and spirit of the invention. Also, well-known functional and structural descriptions have been omitted for clarity and brevity.
With respect to the present invention, the term "data" generally refers to numerical values such as blood glucose level, time of day, dosage and the like. The term "information" generally refers to educational information, feedback, patient qualitative situations, data analysis, and so on. DMCs generally have intellectually owned algorithms for analyzing information and data received from patients, but this information and data is inadvertently or intentionally misreported by patients. Often incorrect due to poor records, inability to contact the patient, etc.
The present invention provides an improved DM system in which the sharing of patient DM-related data with other stakeholders is fully automated and real-time. In addition, improved access to more reliable patient DM data by other stakeholders can improve the use of information to facilitate better management of the disease.
Figure 2 shows the stakeholders in diabetes management. Stakeholders are the patient and, optionally, the patient's caregiver, the patient's healthcare team members (eg, doctors), the patient's insurer, and the patient's employer. As mentioned above, DMC16 may be requested by the patient's insurer or employer to provide patient 12 with educational support for his or her illness. The DMC16 acquires request data such as prescription and healthcare provider visits, pharmacy data and laboratory data, followed by other data such as BG measurements, insulin dosages, A1c levels, regular diet, and exercise. Currently, most of this information is collected from patients over the phone, which has problems (expensive, inconvenient, inaccurate). Other stakeholders in DM can be mail-order companies that provide DM supplies such as test strips to patients and caregivers. As mentioned below, there are currently mail-order companies that mail the maximum number of test strips allowed by Medicare or other third-party payers to patients each month. This practice of mailing strips leads to unfair billing because many of these strips are unused or wasted. The present invention presents the Centers for Medicare and CMS (Centers for Medicare and) of disease management companies, healthcare networks and providers, insurers and CMSs, each of these stakeholders, in particular whose needs are often not emphasized as technological advances in diabetes management progress. Benefits Medicaid Services).
FIG. 1 shows some devices (eg, BGM18 and insulin delivery device 20) that patient 12 or his or her caregiver 34 can use to collect DM-related data and information. FIG. 3 shows additional patient devices and some stakeholders that can be used to connect to and communicate with patient devices in the repository 50 for diabetes data and information, according to an exemplary embodiment of the invention. Indicates a device. Patient devices can include, but are not limited to, background music, insulin delivery devices, location tracking devices, nutrition and other data or information input devices. BGM is, but is not limited to, discontinuous BGM (ie, BGM in which the patient sucks blood onto a test strip for use as a sample, and then the test strip is inserted into a meter and read), or continuous monitor (ie). That is, a catheter inserted under the skin can be used as a monitor for measuring fluid by determining the BG level). Insulin delivery devices include syringes, insulin pens, and insulin jets. It can be an injector), an external insulin pump, and an implantable insulin pump. Position tracking devices can be, but are not limited to, pedometers and GPS tracking devices. Other devices for automating the delivery of DM-related data from patient 12 to other stakeholders can be smart bottles for test strips and wireless syringes, as described in more detail below. Other examples of patient information include a record of activities such as regular diet, exercise, and lifestyle (when to eat, when to exercise, etc.). A WiMax docking station or cell phone may have a display and be programmed to generate a dialog screen for requesting food intake input after noon reading. A GPS tracking device can indicate when a patient is at home or in the gym and generate a screen for entering exercise information. Similarly, a pedometer can monitor general exercise levels through recorded movements.
FIG. 4 shows a repository 50 according to an exemplary embodiment of the invention and the types of data and information stored therein. For example, Repository 50 is allocated to patients with data 64 and 70 from BGM and insulin delivery devices and lifestyle information 74 such as meal time and food intake, exercise, patient location, medical data such as cholesterol, blood pressure, etc. Information 76 regarding the number and lot number of test strips, test frequency and BG level targets and variances, meter / strip calibration data, etc. can be stored. Repository 50 also contains, for each patient, biographical data 68, including one or more recognized patient identifiers, medical data and vital statistics 66, physician orders, appointments, as described below. , And stores the formulation 72 and other information. The repository 50 can also include an analysis algorithm 78 for analyzing the data stored in the repository and a report generation module 80.
Continuing with reference to FIG. 3, a wireless blood glucose meter (BGM) 44 with a BGM 46 and a radio frequency (RF) communication circuit 48 will vary through various RF communication paths 52, according to exemplary embodiments of the invention. Communicate with data user 60 (for example, a patient's wireless communication device, such as a PDA or laptop or PC, doctors and other members of the patient's healthcare team, and a disease management company commissioned to target the patient) can do. Figures 5-17 show devices 44 containing various types of wireless background music or BGM, as well as their respective communication paths to various data and information users. These devices are cellular networks 54 and / or via one or more devices 58, such as mobile phones, personal digital assistants (PDAs), docking stations, personal computers, or other computing devices with communication capabilities. Alternatively, it can communicate with data and information users and the repository 50 directly through the Internet 56. The RF technologies shown in these figures include, but are not limited to, cellular, Bluetooth, wireless USB, WiMax, WiFi, and ZigBee.
With reference to FIGS. 5A and 5B, an exemplary wireless BGM44 is constructed and shown according to an exemplary embodiment of the present invention. The wireless BGM44 includes a display 84 for showing the blood glucose level, the date and time when the level was measured, and other information. This wireless background music has an antenna 86, a test strip reader input 88, and an on / off button 90. FIG. 5B shows port 92 for connecting this wireless meter to another device, such as a docking station or cellular modem.
FIG. 6 shows the components of an exemplary wireless BGM44 constructed according to an exemplary embodiment of the present invention. The wireless BGM44 includes a processor 96, a memory device 98, a display 108, an input device (eg, a keypad 100), a test reader 102, a communication interface circuit 104, an antenna 106, and a power supply 110. The test reader can include an analog front end 112, a test strip interface between strip port 114 and processor 96 for glucose measurement. As described below, it is possible to provide background music that works with the base station as shown in FIG. 11A and therefore does not require antenna 106. The communication interface circuit 104 may be configured such that the wireless BGM 44 can communicate, among other things, using one or more wireless protocols shown in FIG. If the communication interface circuit 104 allows the wireless BGM44 to communicate over multiple wireless protocols, the communication interface circuit 104 scans the available wireless frequencies and is based on modern transmission quality. It can include scanning devices for selecting the best communication protocol to use to transfer data to the repository, such as blood glucose readings.
According to a preferred embodiment of the invention, the wireless BGM44 does not require the user to be involved to send the blood glucose readings to Repository 50 after the test. For example, the wireless glucose meter 44 detects insertion of a strip into a reader, is activated by telephone when the wireless background music is built in or connected to the mobile phone, is activated by the pressure of the wireless background music, or selected exercise. It may be programmed and configured to be an event driven device that automatically sends recently acquired test data from the reader based on its operation. To ensure that Repository 50 is fully receiving the results, it is preferable that an embedded verification function be implemented (ie, any errors in the submitted data should be fully corrected. Yes, or the data will be retransmitted).
The wireless connection of Glucose Meter 44 to Repository 50 and the automatic transfer of blood glucose test results over wireless RF communication pathways will make it easier for patients to comply with diabetes management guidelines. This is because the test results are automatically provided to stakeholders in diabetes management. In addition, the repository data will be more comprehensive. This is because the automatic delivery of test results prevents situations in which the patient or caregiver is unable to perform the test and / or report the test results to the required stakeholders. Also, by communicating the data to the repository, other information (eg, data on the number of tests performed can be used to facilitate test strip prescription tracking and supplementation, and data on insulin delivery A certain level of abstraction and data to provide (which can be used to facilitate prescription tracking and replenishment of supplies).Analysis becomes possible. In addition, as mentioned above, other disease management information is sent to Repository 50, and thus to the required stakeholders, via similar radio frequency communication paths such as GPS, pedometer readings, insulin delivery information, and meal times. Information can be transferred. These devices may have a separate RF circuit connected to the blood glucose meter 46 and / or its RF circuit 48 to communicate this additional information to the repository. Therefore, unlike current glycemic readers and communication interfaces such as patient PCs, data such as glycemic test results and insulin intake, as well as other disease management information, provide a broader perspective. In other words, diabetes management data and other information will be available to more stakeholders, who will have access to more comprehensive information about the patient. In contrast, traditional devices generally provide only a narrow view of test result information and to selected people who cannot control patient compliance in conducting tests and reporting test results. It only gives the selected test results. In addition, traditional glucose meters and other data devices generally use separate communication transactions to send these results to the various people involved, and generally a repository for test results or other information. Do not use.
In addition, the present invention allows the transfer of information from patient 12 and other stakeholders (eg, 14, 16, 40, 42) to the repository and from the repository to the patient and to other stakeholders. , This is preferably, or ideally real-time (eg, immediately after a blood glucose test or insulin infusion). However, the transfer of data between the stakeholders and the repository 50 was selected after the event (eg, the patient test, or the repository algorithm determined that the patient should receive the selected message). It may be configured to be performed within a period of time, or at a selected number of times per day.
FIG. 4 is a block diagram of an exemplary repository 50 according to an exemplary embodiment of the present invention. Repositories are preferably traditional means such as data sent from wireless meters and syringes or pens, those collected as a result of calls between two or more doctors, disease management representatives, insurers, and patients. Numerous records for each patient 12, including data received via, GPS devices, information collected from pedometers, meal time information, etc. 62<sub>1</sub>...62<sub>n</sub>including. As described in more detail below, exemplary embodiments of the invention allow the use of test strips, lot numbers, calibration data, and meter numbers to be maintained for each patient 12. The organization of data and information, as well as their identification for a particular patient 12, can be done in a number of different ways. For example, data received from a communication chip configured for use with Repository 50 can be packetized and transmitted with a header containing a unique identification number assigned to device 44 or 58 as well as patient 12. Data and information about a particular patient 12 can be associated with that patient via multiple identification means. For example, the data on the wireless meter 44 can use an identification code that can be a randomly generated code, and the test strip information is associated with patient 12, for example Medicare, an insurer, or another payer. Can be part of a patient's repository record based on the accepted patient ID assigned by.
Returning to the wireless glucose meters in Figure 5, Figure 7, Figure 8, Figure 9, Figure 10A, Figure 10B, these devices, collectively referred to as 44, are the various RFs between the wireless glucose meter and the repository 50. Indicates the communication path.
FIG. 7 shows a glucose meter 44 having a communication circuit configured to communicate with a device 58, such as a PC, generally designated as 58a, via wireless USB technology. PC58a can communicate with repository 50 via internet 56 or cellular network 54. In other words, the PC 58a may be connected to the Internet 56 via, for example, an analog or digital connection, or to the Cellular Network 54 via a cellular modem card.
FIG. 8 shows a glucose meter 44 with a communication interface circuit 104 with built-in WiFi or WiMax communication capabilities for automatic data transmission to a router or hub for sending meter data (measurement data) to a repository over the internet. ..
FIG. 9 shows a glucose meter having a communication interface circuit 104 with built-in Bluetooth or ZigBee communication capability for automatic data transmission to repository 50 via internet 56 and / or cellular network 54 via user device 58c such as mobile phones, PDAs, etc. A total of 44 is shown.
10A and 10B show the glucose meter 44 communicating with the repository 50 via the cellular network 54. As shown in FIG. 10A, the blood glucose meter 44 can incorporate a cellular communication chip as a communication interface circuit 104. Alternatively, the glucose meter can be equipped with a cellular modem attachment 120, as shown in FIG. 10B.
According to another exemplary embodiment of the invention, the glucose meter 44 is shown in FIGS. 11A, 11B, 11C rather than the communication interface circuit 104 and antenna 106 as described above in connection with FIG. 5A. As such, it may be configured for use with the docking station 124. The docking station 124 includes a cradle 126 for receiving the blood glucose meter 44, a display 128, and some user buttons or controls indicated by 130 overall. The buttons shown at 130 are, but not limited to, buttons for contacting designated people such as doctors, reminders sent from the repository to the docking station according to instructions from the disease management representative or doctor. Buttons for reviewing, buttons for displaying menu options on the display 128, emergency buttons for dialing emergency numbers such as 911 with a single touch, and buttons for showing quick facts on the display regarding diabetes management. Including. Among the menu options is a send option to send recent blood glucose test results to repository 50 when meter 44 is in cradle 126. With reference to FIGS. 11D and 11E, the portable meter 44 has a display 84, a test strip input 88, an on / off button 90, and a port 92 for connecting to the corresponding connector in the cradle 126.
Referring to FIG. 11F, the docking station 124 includes a programmable processor 132, a display 128, a memory device 134, and some connectors 136 for electrical communication with the meter when it is inserted into the cradle. Buttons and other user input devices 130, a communication interface 140 to a repository over the Internet or wireless network, and a power supply 138. The meter 44 electrically communicates with the test strip reader 114, processor 96, memory 98, display 108, on / off button 90 or other user input device, and the docking station when the meter is inserted into the cradle. Has a connector (not shown) for use.
When the glucose meter 44 is docked inside the docking station 124, as shown in FIGS. 12A and 12B, the docking station communicates with the device 58, such as a mobile phone or PDA, via wireless technology such as Bluetooth. The device 58 can communicate with the repository 50 via a wireless network or the Internet. Alternatively, the docking station 124 may be equipped with a cellular modem so that when the meter 44 is in the docking station cradle 126, the docking station 124 can send test results to the repository 50 over the cellular network. ..
Figures 13-16 show other types of devices that have a glucose meter and can be connected to the repository by radio frequency.
13A, 13B, 13C show a mobile phone 142 having a built-in test strip reader 144 and a display 146 similar to that of the blood glucose reader described above in connection with FIGS. 11B and 11C.
As shown in FIG. 14, the mobile phone 148 can make an automatic data transmission connection to the data repository 50 via the cellular network. FIG. 14 shows a mobile phone 148 with a BGM attachment 150.
Figures 15A to 15D are RFIDs for transmitting information such as the syringe identification number and data stored in the non-volatile EEPROM within the tag, such as the insulin type, amount, and insulin type delivered by the syringe. Various views (figures) of an insulin delivery device 160, such as a syringe, with a tag. The amount can be detected and stored based on the movement of the plunger. Thus, when the glucose meter 44 is in close proximity to the syringe 160 and creates a sufficient electromagnetic field, the RFID in the syringe can be activated to send data about the insulin dose delivered by the syringe.
FIG. 15A is a perspective view of a syringe 160 having a cap 162 on the needle. FIG. 15B is a perspective view of the syringe 160 with the cap 164 on top of the insulin reservoir 166 removed. The upper part of the reservoir may be configured with RFID tags, plungers, and plunger motion sensors. 15C and 15D are front and side views of the syringe 160 with the reservoir cap 164 removed.
16A-16E are various views of another insulin delivery device 170, ie, an insulin pen capable of RF connection, according to an exemplary embodiment of the present invention. 16A and 16B are perspective views of the pen 170 covered with the cap 172. FIG. 16C is a perspective view of the pen 170 with the cap 172 removed and the insulin delivery mechanism exposed. 16D and 16E are top and side views of the capped insulin delivery pen.
As shown in FIGS. 16B, 16C, 16D, the insulin delivery pen 170 is a display for showing the insulin dose as well as other information such as the mix amount, the time and date of insulin delivery. Has 174. The pen 170 comprises a communication circuit (not shown) for communicating data to the repository using one of the RF communication paths described above in connection with the glucose meter 44.
The exemplary insulin delivery devices shown in FIGS. 15A-15D and 16A-16E do not require patient or caregiver involvement to communicate insulin delivery data to the repository. Connected syringe data can be sent when meter data is sent and is basically done at the same time as the blood glucose test. Connected pen data can be automatically sent to repository 50 when it detects a completed insulin delivery. Thus, as shown in FIG. 17, insulin delivery data can be transmitted using, for example, the wireless transmission method described above in connection with FIGS. 4-10. Other infusion devices can include, but are not limited to, microneedle delivery, external and implantable insulin pumps with or without a PC interface. Therefore, further referring to FIG. 17, the meter 44 may be configured to communicate with the pump over a local network and with the repository 50 over a wide network, for example. According to an exemplary embodiment of the invention, the pen 170 is configured to store a plurality of dose information that can be automatically transmitted to the repository.
An exemplary embodiment of the invention is a stakeholder in diabetes management, in particular a stakeholder such as a disease management company, insurer, healthcare network, and employer whose function has not been optimized in the past. Allows passive and real-time management of diabetes management data and information. As mentioned above, automatic transmission of glucose meter data and insulin delivery device data to repository 50, as well as collecting, storing and storing diabetes management information such as food intake and exercise and other health parameters such as blood pressure and cholesterol. The use of Repository 50 for access enables increasing patient compliance and increases comprehensive information for consideration by disease management caseworkers, physicians, insurers, and other diabetes management stakeholders. Will be possible. In particular, the DMC will benefit from real-time and comprehensive information and data sent to Repository 50 according to the exemplary embodiments of the invention. In the past, problems common to disease management companies have been the lack of real-time data access (ie, most of the data was collected via telephone conversations between representatives and patients), poor physicians. Involvement, operations could not be scaled cost-effectively and therefore included costly case management. Some improved disease management tasks will then be described with reference to FIGS. 18A and 18B and by exemplary embodiments of the invention.
With reference to Figures 18A and 18B, the disease management company now reviews the various records available for selected patients in Repository 50 (block 180), changes in patient blood glucose levels and other test results. Based on, it is possible to determine when blood glucose test results and other test results, such as the A1c test, are outside the parameters selected for each patient. Disease management companies can prioritize which patients their representatives need to contact and provide additional educational information (blocks 182 and 184). For example, an algorithm in the repository can use parameters specified by stakeholders to determine patients whose test results indicate that immediate attention or intervention is required. The report generation module in Repository 50 is an exception report, that is, the selection of patients whose parameters meet the selected criteria and need to send an alert message over the two-way wireless path of the invention, or simply the generation of an exception report. Enables (blocks 208 and 210). Therefore, stakeholders can use the reporting capabilities of Repository 50 to find out how many hypoglycemic events have occurred among patients within a given time period. In addition, the disease management company can also improve the allocation of cases among disease management representatives and facilitate the management of the number of cases handled by the representatives. In addition, data management companies analyze changes between patient blood glucose data, as well as meal time habits and other stored information, and how often patients test their blood glucose levels and perform other tests, such as the A1c test. Can be customized (blocks 186 and 188). The user is then given a reminder, or level, in the selected range, when a particular test is overlooked by the patient, via the base station, or the display of wireless blood glucose counting. You can send an alert when you are outside (blocks 190 and 196). The alarm is one of the present inventions.
Continuing to refer to Figures 18A and 18B, interested parties can use the communication path shown in Figure 4 or other networks, such as the Public Switched Telephone Network (PSTN), to the repository, and to themselves and their patients. Two-way radio frequency communication between can be used (ie, via a meter, docking station, cell phone, computer, PDA, or other device). The two-way communication provided by the present invention between the patient and other diabetes management stakeholders validates the use of test strips and analyzes repository 50 data on the dose of insulin administered (block 198). To determine compliance with drug treatment by (step 196), as well as an alert sent to the patient (eg, when the test blood is expired or defective, and the test blood glucose level is outside the selected range. , Etc.) (blocks 192 and 206) can be confirmed for receipt (blocks 194 and 200). Repository 50 predicts events for specific patients, such as interested parties analyzing blood glucose levels for short-term, medium-term, and long-term assessments, and blood glucose levels outside the desired range. For this purpose, various test data such as A1c and glycated serum protein test data can be included (blocks 202 and 204). Repository 50 allows you to generate a wider variety of reports because the data is more comprehensive. For example, a disease management company can provide compliance reports (diabetes population trend reports) for selected groups of patients and real-time exception reports. While the reports are linked, various stakeholders (eg, patients, care managers, etc.) also have a unique portal space within the repository so that they can post notes and receive responses among them. And healthcare providers) can be generated. The report should also have information and functional features that change depending on the stakeholders viewing the report.
Accordingly, exemplary embodiments of the invention provide stakeholders with a means to move from passive disease management to real-time and proactive disease management, thus increasing productivity and spending on caseworkers. Direct, such as reducing management costs and time, improving clinical results, increasing patient care and satisfaction (eg, through real-time aspects of viewing and responding to test results), and more involvement of the healthcare team. Bringing profits. These benefits lead to secondary benefits to DMC, such as patient enrollment and increased business opportunities. For example, an insurer may better assess and contract the financial impact of a disease management program based on the results and trend reports available from Repository 50 described above, according to an exemplary embodiment of the invention. You can get better cost effectiveness from your disease management company. Using one or more of the exemplary embodiments of the invention described herein, the healthcare network spends less time collecting data and more time caring for the patient. By providing, productivity can be increased. Repository 50 data can be made available to multiple hospitals and clinical settings. Patients are more satisfied when the healthcare network enrolls in a system according to an exemplary embodiment of the invention. Because patient data is always available, prescribing is automated wherever the patient goes, and patient data is safe to use for legitimate people involved in patient disease management. Is.
Also, exemplary embodiments of the invention allow disease management companies and other stakeholders to monitor drug compliance. For example, diabetes management stakeholders review automatically reported drug doses, as well as collected information in the repository regarding lots of test strips and corresponding test results, and patients test their blood glucose levels. It can also determine if the schedule dictated by the physician is maintained for management in other ways. As mentioned above, an alarm can be sent when the blood glucose level is outside the selected range, or the test strip has expired or needs to be replaced at some other point. Tracking the use of test strips according to the exemplary embodiments of the invention, as described below in connection with FIG. 19, for more effective use of test strips, for the quality and quantity of test strips delivered to the patient. Allows for better control and more efficient billing for Medicare.
Automatic transmission of blood glucose results, test strip lots and meter calibration data allows stakeholders with access to Repository 50 to determine which test strips were actually used. Currently, Medicare guidelines determine the number of test strips sent to diabetics per month. Currently, there is no way to track whether those test strips are actually used. Mail order companies are allowed to charge Medicare for the maximum amount of test strips allocated to a patient, regardless of whether the test strips will be rarely used by the patient. Mail-order companies only need to contact the patient once a month, then send the individual the number of test strips ordered by Medicare, and then charge Medicare for those strips. Absent. Therefore, the significant amount of test strips paid by Medicare will not be used and there is no way to detect the magnitude of such waste.
Referring to FIG. 19, an exemplary embodiment of the present invention has this problem due to the automatic transmission of test results from a meter (eg, meter 44, 142, or 148) to Repository 50 without any user interaction or interference. To solve. Repository 50 is configured to remember the number of test strips allocated to a patient by Medicare, the number of recommended tests per day that the patient should take, and the number of test results received, and how many unfinished. It can be determined if a user has a test strip of use during a particular month (blocks 222 and 224). Based on this information, it is possible to determine if the user needs replenishment of the test strip. Therefore, billing can be based on the number of test strips actually used, which represents a significant savings for Medicare and other payers over current wasteful practices. Also, the repository 50 and automated communications according to the exemplary embodiments of the invention described herein can determine the number of unused test strips left, thus determining replenishment. And allow automatic execution of replenishment (blocks 226 and 228). Vendors can use these automated communications and repository 50 to estimate when a patient will run out of test strips and automatically add to the patient when, for example, only two weeks' worth of supplies are left. Can be sent. Alternatively, the vendor can be messaged not to send any further replenishments until the specified number of test results have been received (block 240).
Continuing to refer to Figure 19, Repository 50 can also allow testing and review of blood glucose results to send facilitative material from pharmacies or pharmaceutical companies to selected patients. As mentioned above, a connected glucose meter (eg, RF meter 44 or mobile phone meter 142 or 148) not only sends the patient a message from the patient's healthcare team, or educational content, but also other types of You can send a message. For example, as part of a business model according to an exemplary embodiment of the invention, an advertisement may be sold to a company that has a targeted message that these patients want to receive (blocks 230 and 232). Thus, for example, a pharmaceutical company introducing a new diabetes treatment can purchase an advertisement whose health profile is sent to a patient who is a potential target for the new treatment. These profiles can be obtained using the algorithm and report generation behavior of Repository 50.
In addition, overall test strip and meter accuracy can be monitored by reviewing blood glucose levels, test strip lot numbers, and meter calibration information, as shown in FIG. 19 (block 238). Finally, an alarm can be sent if the test results are consistently outside or absent from the desired parameters, if the test strip is defective, or if meters 44, 142, or 148 are out of order. (Blocks 234, 236, 238). Accordingly, vendors can be advised to send replacement strips for defective or expired test strips. Therefore, by automatic test result reporting, as well as management of other data such as test strip lot numbers and patient data, such as recommended frequency of tests, and thus tracking of test strip use, expired, to name a few. Or outperform current diabetes management systems such as tracking defective test strips, eliminating abuses such as crowding of test strips and eliminating unfair billing for Medicaid or Medicaid, and monitoring the relationship between test strips and meters. Many benefits are offered.
Currently, Medicare is asking mail-order companies to call patients and ask if they need more test strips before sending them. Mail order companies can track the number of test strips actually used using the connections and repositories of the present invention, thus avoiding the time and expense of making such calls. In addition, DMC finds it difficult and costly to hire staff nurses to manage the number of cases handled. However, the device connectivity and repository 50 according to the exemplary embodiments of the invention described herein can provide a virtual instructor to the patient and reduce reliance on nurses and other case managers. .. Using algorithms on patient device 44, 142, or 148, or in Repository 50, collected and stored data and information in Repository 50, and the two-way communication described herein, medical results can be obtained. Points of education as needed to improve Education) can be generated and sent to the patient via a message.
Also, exemplary embodiments of the invention make it possible to implement a variety of advantageous programs. For example, see Figure 20 to implement a cellular network-based system where monthly subscription fees can be determined based on test frequency and the number of test data uploaded to the repository (block 250). be able to. Monthly subscribers will be provided with a glucose meter and test strip for free or at a fraction of the cost after enrollment to prevent the abuse of billing Medicare for the unused strips mentioned above. Can be done (block 252). When test data for a particular subscriber is uploaded, that data can be reviewed to determine if more strips are needed (blocks 254, 256, 258, 260). It can also determine the overall ability of a patient to control blood glucose within the desired range and cache for physicians and / or patients who show improved diabetes management through improved comprehensive test results. Back incentives or other promotional items can be provided (blocks 262 and 264). In addition, third party payers (eg Medicare) will only pay for test strips with relevant results in the data repository 50, thereby fraud or abuse in the system of refunds for diabetic supplies. Reduce the possibility of.
According to one aspect of the invention, radio frequency identification (RFiD) technology is used to realize advantages over existing disease management devices. The term "radio frequency identification transponder" is used to refer to any class of compact radio transmitter / receiver powered by the surrounding radio frequency electric field. Transponders are accessed by modulating the electric field with the appropriate communication signal. The reaction can be a response signal, changes within the transponder, or both. The content of the communication signal and the response of the transponder are limited by the memory and the control functions provided by the transponder, and by the access bandwidth available for communication. Within these limits, transponders can be read and written in a manner similar to other digital memory devices used to store and retrieve digital information. Radio frequency identification transponders can be widely used in various forms. These devices include non-volatile memory, such as electrically erasable, programmable read-only memory (EEPROM) semiconductor components contained integrally within the transponder. Encoded data is stored in the non-volatile memory. The radio frequency identification transponder also includes an antenna. The shape of the transponder and antenna may vary depending on the particular embodiment. Memory and optional control functions are provided by chips mounted on the support and operably connected to the antenna via reeds.
According to an exemplary embodiment of the invention, as shown in FIGS. 21A and 21B, a body 272, a glucose sensor (not shown) mounted within the body, a display 274, and radio frequencies. A blood glucose monitor 270 with an identification transceiver 276 and at least one radio frequency identification transponder 278 mounted within the body is provided. Transceiver 276 and transponder 278 are unshielded by the body. Line 290 represents the field of ambient frequencies generated by transceiver 276.
During use, the container 280 of the test strip containing the radio frequency identification transponder 282 (integrated with the container label 284 or lid 286, respectively, as shown in FIGS. 22 and 23, respectively), or the radio frequency. The individual test strips 288 (FIG. 24) containing the identification transponders activate their radio frequency identification transponders 282 by the transceiver 276 of the blood glucose monitor, as shown by the line pattern 290 in FIG. Thereby, the test strip container 280, or individual test strip 288, is required for the monitor 270 to calculate an accurate measurement of blood glucose level in the blood sample attached to the test strip 288 (by line pattern 292). You will be sending data containing the encoded (shown).
This exemplary embodiment of the invention realizes some advantages and improvements over existing diabetes management devices. The typical use of a conventional blood glucose monitor requires the user to manually enter the code number corresponding to the code number printed on the test strip container by the manufacturer into the blood glucose monitor. This code number is a type of calibration data that ensures that the results obtained are as accurate as claimed by the manufacturer on the label for the test strip. If the user of the blood glucose monitor does not pay attention to this code number or enters the wrong code number, the blood glucose result obtained may be significantly different from the result obtained with the correct code number. Significantly high or low results can lead to incorrect treatment by users performing blood glucose tests or healthcare professionals. In contrast, when encoded product 292 is transmitted from a test strip container or individual test strip according to an exemplary embodiment of the invention, the blood glucose test ensures that the most accurate results are provided and inaccurate due to user error. There is no possibility of a bad result. The coded product can also include additional information such as date of manufacture, test strip expiration date, lot number, manufacturer identification, and logistics information such as country or region of distribution. This additional information is stored in Repository 50 and is used to send alerts or warnings about expiration dates by the systems of the invention exemplified by the exemplary embodiments disclosed herein, and also by country or. It may be used to enable or disable several combinations of meters and test strips, depending on the region, and to aid in logistics management.
The present invention, exemplified by the exemplary embodiments disclosed herein, provides solutions to problems of the prior art. When blood glucose test strips were manufactured and calibration codes were established for a particular lot, the codes were placed in the container 280 holding these test strips, the individual test strips 288, or both of them in the radio frequency identification transponder 282. Embedded in. When the container 280 of the test strip or the individual test strip 288 is in close proximity to the blood glucose monitor 270, the blood glucose monitor transceiver 276 creates an electric field that activates the radio frequency identification transponder 282 of the container or test strip, and then the transponder The embedded code 292 is automatically sent to the blood glucose monitor 270. The blood glucose monitor 270 then uses this code in calculating the blood glucose results that will be displayed after the test strip with the blood sample has been received within the blood glucose monitor. In addition, the coded product 292 provides information about the individual test, whether from the transponder in the container, from the transponder in the test strip, or from the transponder contained in the monitor itself. Can include. Next, an example will be described.
In the first embodiment, two components, the blood glucose monitor 270 and the test strip container 280, include a radio frequency identification transponder. In this embodiment, the proximity of the test strip container to the blood glucose monitor is required for the monitor to receive the calibration code.
In the second embodiment, two components, the blood glucose monitor 270 and the individual test strips 288, include a radio frequency identification transponder. In this embodiment, a test strip is required to be in close proximity by inserting it into the blood glucose monitor for the monitor to receive the calibration code.
In a third embodiment, the three components, the blood glucose monitor 270, the test strip container 280, and the individual test strips 288, include a radio frequency identification transponder. In this example, the proximity of the test slip container and the individual test strips together means that the blood glucose monitor confirms that the inserted test strip has the same calibration code as the calibration code sent by the test strip container ( Used as confirmation).
In a fourth embodiment, the test strip container 280 stores and transmits a calibration code, test strip expiration date, lot number. These data are interpreted by the meter 270 by comparing the test strip expiration date set in the meter with the current date set in the meter to determine if the test strip 288 used has expired. To.
In a fifth embodiment, test strip 288 stores and transmits a calibration code, test strip expiration date, and lot number. These data are interpreted by the meter 270 by comparing the test strip expiration date set in the meter with the current date set in the meter to determine if the test strip used has expired. ..
In a sixth embodiment, the radio frequency identification transponder 278 in the blood glucose monitor 270 is used to communicate with a pump, or docking station, or other device, such as a detector in a warehouse or manufacturing site. In other words, the pump or docking station can transmit an electric field through the transceiver to determine if the BGM270 is listening and can communicate with the pump or docking station. The detector determines if any of the glycemic monitors are incorrectly packed and therefore sends an electric field that activates the radio frequency identification transponder of the glycemic monitor packed in the crate to avoid shipping errors. be able to.
According to an exemplary embodiment of the present invention, a means for automatically determining the relationship of a diagnostic test performed by an individual to meal time is provided. The relationship of diagnostic tests to meal times is based on the timing of therapeutic interventions performed by the individual. The present invention covers both the analysis process and the parameters used by the analysis process. The present invention exemplifies when determining whether a given blood glucose test is performed pre-meal or post-meal based on the timing of the relevant insulin infusion. Below are two methods for making this determination automatically, namely a parameter-based method (FIG. 26) and an analytical method (FIG. 27), according to an exemplary embodiment of the invention. There is.
In a parameter-based method (FIG. 26), this determination is determined by the therapeutic data indicated by block 300 (eg, insulin infusion) and the diagnostic test data indicated by block 302 (eg, glucose meter test results). ), And their corresponding time stamps, as well as the following set of parameters (block 304) provided by the individual. That is, --A single time (M1) representing the latest, when an individual will have their first meal. --A single time (M2) representing the latest, when an individual will have a second meal. --A single time (M3) representing the latest, when an individual will have a third meal. --A single time (S1) representing the latest when an individual will fall asleep. --A single time (N1) representing the latest, when an individual will be testing blood glucose in the middle of the night.
In parameter-based methods, this determination also relies on the following set of timing thresholds within the analysis. That is, --Blood glucose test times less than 30 minutes prior to infusion time are classified as pre-meal (blocks 310 and 318). --Blood glucose test times that are 90 minutes or more and 180 minutes or less after the infusion time are classified as postprandial (blocks 314 and 320). --Blood glucose test times that are 45 minutes or less before the infusion time and 180 minutes or more after the previous infusion time are classified as pre-meal (blocks 312 and 318). --Blood glucose test times that are greater than or equal to 30 minutes after infusion and less than or equal to 90 minutes after infusion are classified as unknown (blocks 316 and 322).
The allocation of values (block 308) according to this exemplary embodiment of the present invention is as follows. That is, --If the infusion time is before M1 on a given day, the infusion will be associated with the first meal of the day. --If the infusion time is after M1 and before M2 on a given day, the infusion will be associated with the second meal of the day. --If the infusion time is after M2 and before M3 on a given day, the infusion will be associated with the third meal of the day. --If the injection time on a given day is after M3 and before S1, the injection will be associated with the bedtime of the day. --If the infusion time is not after N1 and before N1 + 5 on a given day and the blood glucose test time is after N1 and before N1 + 5, the blood glucose test will be associated with a nocturnal test.
Conflicts between multiple tests are resolved as follows, according to this exemplary embodiment of the invention. That is, if the two blood glucose tests are performed prior to insulin infusion, the blood glucose test with the closest time to the infusion time is used for the analysis. Based on these parameters, the insulin infusion time and blood glucose test time datasets can be analyzed and, for example, the following determinations can be made. That is, Which blood glucose test is associated with the infusion? -Is the blood glucose test classified as a pre-meal or post-meal test for three meal times, a bedtime test, or a night test?
In an analysis-based method (Figure 27), this decision is --Number of daily injections --Number of daily blood glucose tests (block 330) Relies on performing an analysis of personal data to determine. In addition, the individual can provide a number that represents a typical number of meals per day (block 332).
Insulin infusion time and blood glucose test time are examined to determine how those times are clustered (block 334). This can be done using average times throughout the day and some measure of variability and confidence intervals around those times compared to the number of meals per day (block 336). .. It provides a means to divide the day into meal times, bedtime and nights. After those values have been split, the analysis proceeds as in the parameter-based method described above, with a timing threshold, i.e. --Blood glucose test times less than 30 minutes prior to infusion time are classified as pre-meal (blocks 310 and 318), --Blood glucose test times that are 90 minutes or more and 180 minutes or less after the infusion time are classified as postprandial (blocks 314 and 320), --Blood glucose test times that are 45 minutes or less before the infusion time and 180 minutes or more after the previous infusion time are classified as pre-meal (blocks 312 and 318). --Blood glucose test times that are greater than or equal to 30 minutes after the infusion time and less than or equal to 90 minutes after the infusion time are classified as unknown (blocks 316 and 322). Is used to determine if the blood glucose test is pre-meal or post-meal.
This aspect of the invention provides some advantages and improvements over prior art. In the past, determining meal times relied solely on one of two traditional methods. That is, 1. An individual allocates a fixed amount of time before or after his or her meal period. 2. To "mark" an individual's data in such a way as to indicate whether the test or action was performed before or after a meal, at bedtime, or at night. The first conventional method is problematic in that it cannot take into account changes in daily life that may change the timing of meals, bedtime, or midnight events at a fixed time. As a result, data derived from the postprandial period are erroneously represented as occurring before the meal, and vice versa. The traditional second method imposes an extra effort on the individual to classify each event for later analysis or to "mark" each value retroactively according to the classification. .. It is unlikely that an individual will spend time marking every event, or that he will remember to mark every event when it occurs. Further, if the "marking" is performed retroactively, the accuracy of the memory is reduced, and therefore the accuracy of the event allocation is reduced.
The exemplary embodiments of the invention described in connection with FIGS. 26 and 27 solve the problems encountered in these conventional methods. First, these embodiments use the timing of therapeutic interventions that are generally associated with the period immediately before a meal or just before bedtime, and use its occurrence as an indicator of mealtime or bedtime. Therefore, the accuracy of these embodiments of the invention is directly related to the accuracy of time information regarding therapeutic interventions. Therefore, if the time stamps of therapeutic interventions are themselves automated and determined more accurately, the way these embodiments correctly classify the timing of diagnostic tests is improved. Second, these embodiments establish timing thresholds that provide the ability to determine the most likely physiological relationship between therapeutic interventions and diagnostic tests.
Referring to FIG. 28, a variant of the above-mentioned analysis-based embodiment is used with an analysis engine that includes an iterative learning algorithm that uses feedback from individuals to improve classification accuracy over time. That is, the analysis engine can be performed as described above using the initial dataset from the individual, but the individual then sends feedback in the form of corrections or changes to the categories defined by the engine. Can be done (block 340). The analysis engine then incorporates this feedback into its algorithm and requires some corrections during continuous analysis (block 342).
The technical principle underlying this aspect of the invention is a series of date and time comparisons performed on a dataset containing two categories of values, where each value within each category has a unique date and Has a time stamp. The first part of this technique compares dates and times in two categories of data and finds a close relationship between data points, expressed in time. The second part of this approach depends on whether the parameter-based method (Fig. 26) is used or the analysis-based method (Fig. 27) is used. Generally, this part makes assignments to external parameters or according to the statistical analysis of the dataset for pre- or post-meal, bedtime, or nighttime categories.
The ability to establish timing thresholds that link two categories of data or values is the basis for both methods in FIGS. 26 and 27. These timing thresholds will be based on clinical experience and physiological data, or on analysis of individual datasets over time. A relevant aspect of the invention is the improvement in accuracy when the date and time stamp accuracy of the treatment intervention is improved, especially when the date and time stamp of the treatment intervention is automatically determined and stored in the dataset. is there. An algorithm for implementing a dataset (for example, two categories of data and their time-represented relationship) and a parameter-based or analysis-based method can be found in the repository or on the device. It can be provided within themselves. Placing datasets and algorithms within Repository 50 simplifies the device and realizes the benefits described above (eg, reduced development time and therefore time to sale, reduced complexity, and therefore potential for harm. (Reduced, increased usable life of the device). In any case, the data in the repository 50 or in the device itself (eg, meter 44) can be analyzed to abstract information about patient behavior. This analysis may provide another benefit of improved messaging. In other words, Repository 50 can run one or more algorithms to determine when messages, such as alerts and educational messages, should be sent to the patient. Analyze patient test results, insulin intake, and meal times to determine the optimal time to send a reminder to a patient, for example, to take a test, to take insulin, or to schedule an outpatient visit. be able to. Also, algorithmic processing of the contents of Repository 50 influences the patient's willingness to receive information that would have an optimal impact on the patient's behavior and the person's practice of diabetes management. To
Another benefit is that if you have a device that can communicate wirelessly "always on" (eg, Meter 44), you no longer need the complex firmware in the device to perform the analysis operation. For example, many BGM devices today provide BG averages, or graphical trend data. With the type of system according to the exemplary embodiments of the invention described herein, the device (eg, meters 44, 142, 148) need not have any of these analytical functions. On the contrary, it only acts as a display device for analysis performed at the repository level. In this way, the device becomes less complex, thereby reducing some benefits (eg, reducing development time and thus time to sale, reducing complexity, and thus reducing the potential for harm, software "upgrades". ) Is performed at the repository level rather than at the device level, resulting in increased usable life of the device by not having to replace the device, device firmware upgrades, without the need to replace the device. Brings what can be done wirelessly.
29-31 show improved services and potential income realized by the systems of the invention shown in FIGS. 3 and 4 and illustrated herein in FIGS. 5a-17. Describes the interests of. 29, 30, and 31 show the benefits of connectivity and value-added information provided by exemplary embodiments of the invention in the context of patient and disease management as a whole.
As shown in Figure 29, the left side of the dotted line is the current measurement practice of various diagnostic data shared between the patient and healthcare provider and the other participants mentioned above in the background section. Set boundaries. The right side of the dotted line shows the advantages of exemplary embodiments of the invention. For example, effortless data capture and transmission operations and repositories of connected BGMs, continuous glucose monitors (CGMs), and insulin delivery devices according to exemplary embodiments of the invention described herein. The "information from data" service provided using 50 is not limited to customers, including patients, caregivers, DMCs, healthcare providers, IHN (integrated health network), employers and insurance companies. To realize integrated services for both companies and companies. In addition to diabetes, the patient and disease management services provided by the exemplary embodiments of the invention are, but are not limited to, lung care, heart care, fitness care / well-being. It is useful for various types of healthcare conditions, including care). Figures 30 and 31 show examples, such as the Diabetes Nursing Educator (DNE), who tracks hundreds of patients through the repository portal and notes that some patients need immediate attention. It is provided.
Figures 32-37 show the benefits of retail money flow provided by exemplary embodiments of the invention. For example, FIGS. 32 and 33 show product flows, such as test strips, from BGM manufacturers to patients through wholesalers and retailers, and revenue flows between these participants, respectively. Figures 35 and 36 show similar participants, except for third-party payers, such as managed care organizations, rather than Medicare. Figure 37 also includes a pharmacy benefit management company (PBM). Figure 34 shows the product flow from the BGM manufacturer to the patient through the endurance medical device supplier or DME, and the revenue flow between these participants. Accurate test result reporting, proactive disease counseling, test strip tracking, and other benefits of exemplary embodiments of the invention provide the additional benefit of significant cost savings, thus rebating as shown. To enable.
38, 39, 40 are among DM stakeholders brought about by a model that pays for the results, performed according to exemplary embodiments of the invention, such as determining the actual use of the test strip. Shows improvements over current cash flow. As shown in Figure 38, the disease management company should receive 50 test strips per month from an order in Repository 50, based on the patient's current prescription test frequency. Can be determined. Mail-order or retail vendors can purchase 50 strips from BGM manufacturers, ship them to patients, and charge DMC for payment. The DMC and / or payer was determined from the repository that only 46 test strips were used by the patient during the selected period using the method described above according to an exemplary embodiment of the invention. Can be decided. The payer only has to pay for 46 test strips. The DMC and / or payer may receive a rebate on four unused test strips.
41A to 41D, 42, and 43 show the additional advantages of the connected disease management devices and data acquisition, as well as the analytical methods, described herein with reference to exemplary embodiments of the invention. Shown. FIG. 41D shows how the system shown in FIG. 3 collects blood glucose levels, dates and times, such as other optional data such as pre-meal and post-meal readings. As shown in Figure 41B, users are given real-time feedback based on the information analyzed within Repository 50 (eg, ADA target values for blood glucose levels or physician-prescribed target values). The required insulin dose, which can be sent to BGM to encourage the user to take the required drug level, using the data in the repository, as shown in Figure 41C. Or other drugs can be calculated. With reference to Figure 41D, test and dose data, such as nutrition and other information such as pre- or post-meal blood glucose levels, are stored in Repository 50 and are stored by various stakeholders such as patients, healthcare providers, DMCs, etc. Used by. As shown in FIG. 42, data can be collected, analyzed, and summarized within the display screen for several patients in order to more effectively manage the diabetic population. The display screen is color-coded or shaded to help identify patients with recent readings, averages over selected days, and patients with high, low, or target ranges of ranges or readings. Quantitative compliance can be included. As shown in FIG. 43, data about selected patients can be captured on the display screen as a one-page action plan along with additional information such as blood glucose averages over time.
An exemplary embodiment of the invention described herein can be implemented as a computer-readable code on a computer-readable recording medium. A computer-readable recording medium is any data storage device capable of storing data that can then be read by a computer system. Examples of computer-readable recording media include, but are not limited to, read-only memory (ROM), random access memory (RAM), CD-ROM, magnetic tape, floppy disks, optical data storage devices, and (wired or wireless communication). Carriers are included (such as data transmission over the Internet over a route). Also, the computer-readable recording medium can be distributed via a networked computer system so that the computer-readable code is distributed, stored and executed. In addition, the functional program, code, and code segment for achieving the present invention can be easily interpreted by a programmer in the art to which the present invention is related as being within the scope of the present invention.
Some exemplary embodiments of the invention have been shown and described herein with reference to some preferred embodiments thereof, but the modifications in the embodiments and details are in the appended claims. And those skilled in the art will appreciate that they can be added without departing from the spirit and scope of the invention as defined by their equivalents.
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- 2012210441
- Publication, EPODOC
- JP2012210441
- Application
- 144580
- Application, DOCDB
- 2012144580
- Application, EPODOC
- JP20120144580
Titles2
- Japanese
- 改良された糖尿病データ管理のためのシステムおよび方法、および使用法
- English
- Systems and methods for improved diabetes data management, and usage
Classification
- CPC, 20
- A61B5/0002
- A61B5/14532
- A61B2560/0271
- A61B2560/0456
- A61M5/14244
- A61M2205/3561
- A61M2205/3569
- A61M2205/3576
- A61M2205/6018
- A61M2230/201
- G16H40/63
- G16H10/60
- G16H50/20
- G16H15/00
- Y10T436/144444
- G16H20/17
- G16H20/60
- G16H20/30
- G16H40/67
- G16H80/00
- IPC, 9
- A61G12 00
- G16H10 60
- G16H20 17
- G16H20 30
- G16H20 60
- G16H40 67
- G16H80 00
- G06Q50 22
- G06Q50 24