JP2008253560A - Device for detecting pseudohypoglycemia and issuing alarm - Google Patents

Device for detecting pseudohypoglycemia and issuing alarm Download PDF

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JP2008253560A
JP2008253560A JP2007099515A JP2007099515A JP2008253560A JP 2008253560 A JP2008253560 A JP 2008253560A JP 2007099515 A JP2007099515 A JP 2007099515A JP 2007099515 A JP2007099515 A JP 2007099515A JP 2008253560 A JP2008253560 A JP 2008253560A
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hypoglycemia
tremor
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Shinichi Yoshida
伸一 吉田
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Abstract

<P>PROBLEM TO BE SOLVED: To solve the following problem that a general treatment of diabetes includes dose of an antihypoglycemic agent or insulin injection so as to prevent a complication by hyperglycemia (going blind, renal insufficiency, or the like), but hypoglycemia is caused as the side effects, generally, hypoglycemia is said to occur when the blood-sugar level is 60 mg/dl or lower, the loss of consciousness is caused, brain cell cannot be provided with nutrition when it becomes 20 mg/dl or lower, a part of the brain cell begins to die, unless an urgent treatment is given, grave illness develops, a vegetable existence is led, brain death is caused by further neglect, and eventually a patient dies. <P>SOLUTION: A device for detecting pseudohypoglycemia and issuing an alarm detects a part or whole of (1) perspiration, (2) an increase in heart rate, and (3) tremor which are characteristics of hypoglycemia symptom, compares respective data with daily normal values, determines hypoglycemia in a pseudo manner by a machine with a program having a learning function incorporated, issues an alarm to a patient himself or herself or a nurse (including his or her family) before the consciousness is lost, and restores the hypoglycemia symptom to the normal state by facilitating intake of glucose or the like. <P>COPYRIGHT: (C)2009,JPO&INPIT

Description

在宅治療の場合は家庭で、入院治療の場合は病院で使用される糖尿病患者用の医療機器 Medical devices for diabetics used at home for home treatment and at the hospital for hospitalization treatment

糖尿病患者の治療の多くは何らかの原因で失われた血糖値自動制御を食事(血糖上昇要因)と運動・薬物(血糖降下剤の服用、インスリンの皮下注射など血糖降下要因)とのバランスを取りながら、正常値(80〜110mg/dl)に近くなるよう手動制御することである。   Many treatments for diabetics balance the automatic control of blood sugar level lost for some reason with diet (rising factor of blood sugar) and exercise / drug (dose of hypoglycemic agent, hypoglycemic factor such as subcutaneous injection of insulin). The manual control is performed so as to be close to the normal value (80 to 110 mg / dl).

手動制御するには多数回、血糖値を測定し、そのデータを専門医が解析し、薬物を処方して行う。特にインスリンの分泌が殆ど無い一型糖尿病患者の血糖手動制御は極めて困難である。糖尿病が強く疑われる人は日本だけでも740万人(平成14年度厚生労働省調査)と言われ、現在治療を受けている人は約半数の50.6%で約370万人の大半が血糖降下剤の服用、又はインスリンの注射をしていると推測される。
糖尿病患者の95%以上は二型で高血糖になるとインスリンが分泌されるのと多種のインスリンが開発されある程度の治療法も確立して、血糖値制御が比較的容易と思われる。
Manual control is performed many times by measuring blood glucose levels, analyzing the data by a specialist, and prescribing drugs. In particular, manual blood glucose control is difficult for type 1 diabetic patients with little insulin secretion. Diabetes is strongly suspected to be 7.4 million in Japan alone (FY2002 survey), and about half of those who are currently receiving treatment are 50.6%, with the majority of 3.7 million being hypoglycemic. It is presumed that he is taking a drug or injecting insulin.
More than 95% of diabetics are dimorphic and have high blood sugar levels. Insulin is secreted and various types of insulin are developed, and a certain amount of treatment is established.

近年、血糖簡易測定器は非常に簡便になり、患者独自で簡単に測定可能になったが、血糖値測定には採血が必要であり、自動採血装置が現時点では非常に大掛かり(ロボット技術を採用した高価な装置)になり、自宅療養の患者には不適当である現在、24時間連続血糖値監視は技術的にも、費用的にもほぼ不可能である。   In recent years, simple blood glucose measuring instruments have become very simple and can be easily measured by patients. However, blood glucose measurement requires blood collection, and automatic blood collection devices are currently very large (using robot technology). Currently, 24-hour continuous blood glucose monitoring is almost impossible both technically and cost-effectively.

高血糖は種々の合併症(失明や腎不全など)を誘発するので、血糖値を低くするように専門医から指導されている。よって患者は食事の摂取カロリーと、運動によるカロリー消費や血糖降下剤の服用や注射のバランス取るべく努力しているが、胃腸の調子により摂取カロリーが不足した時などや、それが他の要因(自己不可避の運動など)と重なり、低血糖症状を誘発する。   Hyperglycemia induces various complications (blindness, renal failure, etc.), so it is instructed by specialists to lower blood glucose levels. Therefore, the patient is trying to balance the calorie intake and calorie consumption by exercise, taking hypoglycemic drugs and injections, but when the calorie intake is lacking, there are other factors ( It induces hypoglycemic symptoms when combined with inevitable exercise.

低血糖は全身の細胞への栄養供給に支障を来たし、特に脳細胞の死に繋がるので、とても危険な状態を招く、特に就寝中に低血糖症状を起こし、その状態で意識喪失した本人は勿論、家族も気付かづ、朝まで放置された場合、良くて「植物人間」悪ければ、死亡する可能性が高くなる。
特開2000−036091号公報
Hypoglycemia hinders the supply of nutrients to cells throughout the body and leads to the death of brain cells in particular. If a family member also notices and is left until morning, if it is good and “plant human” is bad, the possibility of death increases.
JP 2000-036091 A

生命の危険もある低血糖症状を早期(出来れば意識喪失前)に検知し、警報により就寝中でも起床し、本人自身でブドウ糖などの摂取により、低血糖症状からの回復を図ろうとするものです。一般に持参している10gのブドウ糖や市販の「コーラ」150ccの摂取で一時的にも正常に戻れる事が多いのです。   Hypoglycemic symptoms that can be life-threatening are detected early (preferably before loss of consciousness), wakes up while sleeping, and attempts to recover from hypoglycemic symptoms by ingesting glucose or the like. In general, it is often possible to return to normal temporarily by ingesting 10 g of glucose or 150 cc of commercially available “cola”.

血糖値を24時間測定する技術が確立され、一般糖尿病患者が日常生活の中で、簡便に使用出来るまで、この症状を監視する擬似低血糖検知・警報器は脳細胞の一部の死による「ボケ」や、生命維持以外の脳細胞の死に寄る植物人間の発生防止に貢献出来ると確信します。   A technology that measures blood glucose levels for 24 hours has been established, and a pseudo-hypoglycemia detector / alarm that monitors this symptom until general diabetics can easily use it in their daily lives is based on the death of some of the brain cells. I am convinced that it can contribute to the prevention of the occurrence of “bokeh” and plant human beings who are close to the death of brain cells other than life support.

本発明は低血糖症状の代表的症状である「発汗」に注目し、患者の胸部に貼り付けた2個の電極間の抵抗値が、汗により急激に降下することを検知して警報機(ブザー)を鳴らす発汗検知器で、簡易低血糖検知器として、試用しました。
しかし、発汗作用は低血糖症状だけでなく、気温の高い季節や冬季の暖房の効き過ぎでも発汗を起こし、警報機(ブザー)が鳴った、が、採血して、血糖値を測定してみると、血糖値が150mg/dl以上(低血糖ではない)と言う誤報が続発しました。
The present invention pays attention to “sweat”, which is a typical symptom of hypoglycemia, and detects that the resistance value between the two electrodes attached to the chest of the patient is drastically lowered due to sweat. This is a sweat detector that sounds a buzzer, and was used as a simple hypoglycemia detector.
However, the sweating action is not only a hypoglycemic symptom, but also caused sweating even when the temperature is high or the heating in winter is too effective, and an alarm (buzzer) sounded. And the false alarm that blood sugar level is 150mg / dl or more (not hypoglycemia) occurred.

上記の課題解決のため、低血糖になると脳細胞が栄養不足から、血液量を増やす様、脳が心臓に指令を発し、心拍数を増やす、この症状(脈拍数増加)を検知して、上記発汗検知と併用する事にしました。又、体温、室温をもデータとして、採用する事により誤報を少なくする事が出来ました。   In order to solve the above problem, when hypoglycemia occurs, the brain cells give a command to the heart to increase the blood volume, so that the brain increases the heart rate, detecting this symptom (increased pulse rate) We decided to use it together with sweat detection. In addition, by using body temperature and room temperature as data, we were able to reduce false alarms.

極度に低血糖(15mg/dl以下)になると発作(振戦、すなわちふるえ)が起こる。これは脳細胞の大量死の警報と思われ、非常に危険な状態であるのでこの発作の検知を患者の身体の一部に取り付けた加速度センサーにより検知し、最高レベルの警報を発する。
この段階では栄養が不足しているのに発作運動でエネルギーを消費しているので益々、血糖値が低くなると思われ、秒を争って、ブドウ糖の静脈注射又はグルカゴン(血糖上昇ホルモン)の筋肉注射が必要である。
If extremely hypoglycemia (15 mg / dl or less) occurs, seizures (tremors or tremors) occur. This seems to be a warning of the death of brain cells and is a very dangerous situation, so the detection of this seizure is detected by an accelerometer attached to a part of the patient's body, and the highest level of warning is issued.
At this stage, it is thought that the blood sugar level is gradually lowering because energy is consumed by seizure exercise even though there is a lack of nutrients, and intravenous injection of glucose or intramuscular injection of glucagon (hypoglycemic hormone) is competing for seconds. is required.

一般に患者は一人一人、特に加齢による諸能力低下などにより、大きな個人差があるので、低血糖症状の現れ方も異なると思われる。極端には発汗能力が低下した高齢者の存在も予測され、低血糖を起こしても、発汗しない患者も予測しなくてはならない。
その課題に対する為、本体内にCPUを設置し、事前に患者個々の正常状態と低血糖症状のデータ(1)発汗、(2)心拍数の増加、(3)ふるえ(振戦)の有無、(4)体温、(5)室温を収集して、又、誤報の経緯を通知する事により、低血糖判断の基準を改良する学習機能を持ったプログラムによって判断する。
In general, there is a large individual difference in each patient, especially due to a decline in various abilities due to aging, and so the appearance of hypoglycemia symptoms seems to be different. In the extreme, the existence of elderly people with reduced ability to sweat is also predicted, and patients who do not sweat even if they develop hypoglycemia must be predicted.
In order to deal with the problem, a CPU is installed in the main body, and in advance the normal state of each patient and hypoglycemic symptoms data (1) sweating, (2) heart rate increase, (3) tremor (tremor), (4) Collect body temperature, (5) Collect room temperature, and notify the background of misinformation, and judge by a program with a learning function to improve the criteria of hypoglycemia judgment.

本来なら、患者の血糖値を日常生活の中で連続24時間連続自動測定し、血糖が60mg/dl以下になると、警報を発すれば良いのだが、残念ながら、現在、そのような測定器は少なくとも一般に市販されていない。   Originally, the patient's blood sugar level should be automatically measured continuously for 24 hours in daily life, and if the blood sugar falls below 60 mg / dl, an alarm should be issued. At least generally not commercially available.

本発明は、低血糖症状の特異性を検知し、意識喪失前に患者本人に警報を発し、本人が(必要ならば、現在一般に普及している採血による簡易血糖測定器により測定し)、ブドウ糖などを摂取して、低血糖症状よりの早期回復を図ろうとするものです。
これにより、本人の脳細胞の死滅を最小限に出来、特に周囲の家人や救急車の出動などの傍迷惑を少なくする事が出来る。
The present invention detects the specificity of a hypoglycemia symptom, issues an alarm to the patient before loss of consciousness, and the person himself (if necessary, measures with a simple blood glucose meter by blood sampling, which is currently widely used) To try to recover early from hypoglycemic symptoms.
As a result, the death of the brain cell of the person can be minimized, and in particular, the side troubles such as the dispatch of surrounding householders and ambulances can be reduced.

検知部を患者の身体表面に貼り付けるわけだが、(1)発汗(電極間の抵抗値計測)、(2)脈拍検知(電極間の抵抗値の波動)、(3)振戦(ふるえ)(4)体温の検知部は一体化が可能であるので、なるべく装着の違和感を無くすよう小型軽量化し、全て無線で本体にデータを送出する。その間隔は初期値は1分間隔で行うも、学習機能により、徐々に間隔を広げ、30分間隔まで広げる事が可能で、電池の消耗を抑えるよう設計する必要がある。   The detection part is attached to the patient's body surface. (1) Sweating (measurement of resistance between electrodes), (2) Pulse detection (wave of resistance between electrodes), (3) Tremor (tremor) ( 4) Since the body temperature detection unit can be integrated, it is reduced in size and weight so as to eliminate discomfort as much as possible, and all the data is transmitted wirelessly to the main body. Although the initial value is set at an interval of 1 minute, it is possible to gradually increase the interval by the learning function and increase it to an interval of 30 minutes, and it is necessary to design so as to suppress battery consumption.

尚、簡易型は有線で、最も危険と思われる就寝中のみ検知部を枕元に設置した本体に接続すれば良く、低血糖症状の判定精度を落とせば、さらに簡易型として発汗検知と気温(体温)に警報ブザーを付けたものでも有効と思われる。   The simple type is wired, and it is only necessary to connect the detection unit to the body installed at the bedside only when sleeping, which seems to be the most dangerous.If the accuracy of hypoglycemic symptoms is reduced, sweat detection and temperature (body temperature) can be further reduced. ) With an alarm buzzer is also considered effective.

遠隔地や独居患者においては携帯電話やPHSの技術で遠隔地の親族などへ全ての情報を発信すればよい。又、その場合、テレビ電話やインターネットテレビ電話の併用も非常に有効と思われる。   In remote areas and single patients, all information can be transmitted to relatives in remote areas using mobile phone or PHS technology. In that case, the combined use of videophones and Internet videophones would be very effective.

本体に内蔵されたCPUのプログラムには自己学習機能を持たせ、患者特有のデータの収集用パソコンシステムを開発し、患者と検知部、本体とパソコンシステムを接続し、専門医の監督の下、(故意に)低血糖を起こし、データを収集(本体の教育)する。又、室温を高温にして発汗データを収集すれば、本体の低血糖判定精度が向上する。その間隔については通常、1年に1度と推測されるが、急激な体力の変化、特に認知症やアルツハイマー症などの発症により、脳の能力に大きな変化がある場合には1ヵ月毎に1回のデータ収集の必要性も想定される。   The CPU program built in the main unit has a self-learning function, and a personal computer system for collecting patient-specific data is developed. The patient and the detection unit, the main unit and the personal computer system are connected, and under the supervision of a specialist ( (Deliberately) cause hypoglycemia and collect data (education of the main body). Further, if the sweating data is collected at a high room temperature, the accuracy of determining the hypoglycemia of the main body is improved. The interval is usually estimated to be once a year. However, if there is a significant change in brain performance due to sudden changes in physical strength, especially dementia and Alzheimer's disease, the interval is 1 per month. The need to collect data once is also envisaged.

低血糖を判断するデータ類はなるべく多くの患者より集めて作成した初期値(デフォルト値)を設定し、新患者に使用を開始するが、患者本人の毎日の収集データにより、本体は自己学習し、プログラムを改良する機能を持たせると共に、使用してきた本体を主治医の医院に持ち込む事により、主治医がパソコンで症状の経緯が把握でき、より良い治療を行えると思われます。   The initial values (default values) collected from as many patients as possible are set for data to determine hypoglycemia, and use is started for new patients. However, the main body self-learns based on the patient's own daily collected data. In addition to providing functions to improve the program, bringing the main body used to the doctor's office will allow the doctor to understand the symptom history and perform better treatment on a personal computer.

又、本体直接、又はパソコンを介してPHS又は携帯電話に接続し、予め契約したメーカーのソフトウエア保守センターと直接交信することにより、設備の安全性や保守(プログラムのバージョンアップも含む)が可能になる。ソフト・ハード全てにフールセーフの原則で、(図2)の様な回線によるサービスが整備され、作成された製品が最良の形態と思います。   It is also possible to connect to a PHS or mobile phone directly through the main unit or via a personal computer and communicate directly with the software maintenance center of the contracted manufacturer, thereby enabling facility safety and maintenance (including program upgrades). become. I think that the best form is a product that has been developed with a line-based service (Fig. 2) based on the principle of full-safety for all software and hardware.

基本説明図(実施例1) 患者本人の胸部に取り付けた検知部より、電極間の抵抗値の変化による発汗状態・脈拍数、温度センサーによる体温、加速度センサーによるふるえ(振戦)の状態を収集、そのデータより、低血糖症状であると判断した場合、患者本人と介護人に音、光、振動などにより警報を発し、患者本人が意識あれば、自分でブドウ糖などを摂取、低血糖状態からの回復を図る。不幸にして、意識喪失後は介護人・看護人が、グルカゴン(血糖上昇ホルモン)を注射して、低血糖状態よりの回復を図る。Basic explanatory diagram (Example 1) From the detection unit attached to the patient's chest, sweating and pulse rate due to changes in resistance between electrodes, body temperature by temperature sensor, and tremor state by acceleration sensor are collected If it is determined from the data that the symptoms are hypoglycemic, the patient and caregiver will be alerted by sound, light, vibration, etc. To recover. Unfortunately, after loss of consciousness, the caregiver / nurse injects glucagon (a hyperglycemic hormone) to recover from the hypoglycemic state. 緊急通報・設備保守(実施例2) 本体に携帯電話又はPHS電話を直接制御可能であれば、直接接続するが、開発中などにはパソコンを接続、音声での通報機能を持たせれば、119番による救急車呼び出しも可能である。又、設備が全て正常、安全であるかの自動点検も定期的に行え、設備の保守を含め信頼度の高い設備が維持できると思われる。図2で携帯端末とPHS端末が重複しているのは回線混雑などによる不通の予備設備である。状況によっては、有線(一般の公衆回線)や安全の確認が取れれば、インターネット回線も使用可能である。これらの端末機は主治医からの点検や症状把握、メーカー側からのプログラム・バージョンアップや設備の点検などのサービスを受ける事も可能である。Emergency call / equipment maintenance (Example 2) If the mobile phone or PHS phone can be directly controlled to the main unit, it will be connected directly, but if it is under development, etc., if a personal computer is connected and a voice notification function is provided, it will be 119 An ambulance can be called by number. In addition, it is possible to regularly check whether all equipment is normal and safe, and to maintain highly reliable equipment including equipment maintenance. In FIG. 2, the portable terminal and the PHS terminal overlap with a spare facility that is disconnected due to line congestion. Depending on the situation, a wired (general public line) or an Internet line can be used if safety can be confirmed. These terminals can also receive services such as inspection from the attending physician, understanding of symptoms, program upgrades from the manufacturer, and equipment inspection.

Claims (2)

低血糖の自律神経症状である(1)発汗、(2)脈拍の増加、(3)ふるえ(振戦)の一部又は全てを検知し、有線、無線、光、超音波のいずれかにて本擬似低血糖検知器に情報を送る。その情報とは発汗による電極間の抵抗値、脈拍数、体温、ふるえ(振戦)の大きさ及び振動数である。本体内CPUのプログラムでは事前及び直前の観測によって得たデータにより各情報分析の結果、低血糖症状の可能性が高いと判断した場合、患者本人並びに看護人又は周囲の人に音、光、振動の一部又は全てにより警報を発し、ブドウ糖等の摂取を促し、より重篤な状態への移行を防ぐ事を目的とした擬似低血糖検知・警報発信器。 又、本体内のCPUには対象患者の個人差に合わせ、日々、誤報を少なくする為の自己学習機能を持たせた機器も含む。   Detects some or all of the autonomic symptoms of hypoglycemia (1) sweating, (2) increased pulse, (3) tremor (tremor), and either wired, wireless, light, or ultrasound Send information to the simulated hypoglycemia detector. The information includes the resistance value between the electrodes due to sweating, the pulse rate, the body temperature, the size of tremor (tremor), and the frequency. In the program of the CPU in the body, if it is determined that the possibility of hypoglycemia is high as a result of each information analysis based on the data obtained from previous and previous observations, sound, light, vibration to the patient and the nurse or the surrounding person Pseudo-hypoglycemia detection / alarm transmitter aimed at issuing an alarm by part or all of the above, urging the intake of glucose, etc., and preventing the transition to a more severe state. In addition, the CPU in the main unit also includes devices with a self-learning function to reduce misinformation every day according to the individual differences of the target patients. 検知部、CPUを含む本体、警報発信器間の情報交信は有線に加え、専用無線及びPHS、携帯電話の交信技術を応用したものを含むと共に、複数患者を同時に集中監視する擬似低血糖検知・警報発信装置をも含む。   The information communication between the detection unit, the main body including the CPU, and the alarm transmitter includes not only wired communication, but also the application of dedicated wireless, PHS, and mobile phone communication technology. Also includes an alarm transmitter.
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