Began clinical research at the University of Tokyo Medical School Hospital and treatment application dedicated to NASH (Non-Alcoholic Steatohepatitis)
CureApp will begin clinical research using a therapeutic application dedicated to NASH (Non-Alcoholic Steatohepatitis) developed in collaboration with the Department of Gastroenterology of the University of Tokyo Hospital.
CureApp will begin clinical research using a therapeutic application dedicated to NASH (Non-Alcoholic Steatohepatitis) developed in collaboration with the Department of Gastroenterology of the University of Tokyo Hospital.
1. Presenter:
Masaya Sato: Specialized Clinician (Department of Internal Medicine, Gastroenterology), Department of Inspection Dept., University of Tokyo School of Medicine Affiliated Hospital
Ryosuke Koseishi: Graduate School of Medicine, University of Tokyo Graduate School of Medicine, Graduate School of Gastroenterological Sciences Guest Lecturer
Kazuhiko Koike: Graduate School of Medicine, Kyoto University Professor of Gastroenterology
2. Presentation Points:0
NASH ◆ At the University of Tokyo Medical School Hospital the world's first NASH (Non-Alcoholic Steatohepatitis: Non-Alcoholic
Steatohepatitis) medical application based treatment will begin clinical research using our special treatment application. ◆ Patients can receive medical guidance properly, not only during their outpatient treatment but also through their daily lives. ◆ This study is expected to improve NASH pathology and life expectancy prognoses by providing medical guidance specific to a patient’s unique condition in real time for diet therapy, exercise therapy, behavioral therapy and other efforts.
3. Presentation Summary:
Masaya Sato: A special clinician of the Graduate School of Internal Medicine, The University of Tokyo Hospital, Ryosuke Kenseishi Special Lecturer:
We will begin clinical research on a therapeutic application dedicated to NASH jointly developed by Koike Kazuhiko's group and CureApp.
It is well known that NASH progresses to liver cirrhosis and liver cancer, and there are concerns that instances of NASH-based liver cancer will increase in the future.
NASH that develops due to a history of obesity prevails in Japan in about 2 million individuals (Preliminary estimates are about 10 million). However, there is currently no effective established treatment method other than nutritional guidance for weight reduction from consultation with a doctor. We are staying true to the efforts of individual facilities who use various forms of exercise. Moreover, it is actually difficult to conduct appropriate behavioral therapy on patients in the limited time frame of their outpatient checkups.
Therefore if an application that continually performs clinical guidance optimized for each patient, not including the time of outpatient examinations, that obtains positive results without significantly increasing the burden on both the patient and the medical staff, such an application, is expected to be a promising form of treatment of NASH
In addition, if treatment by weight loss through the improvement of a patient's awareness and behavior is achieved, not only may it be possible to prevent cirrhosis and liver cancer from developing, but may also provide prevention of other obesity caused illnesses ultimately reducing the cost of medical bills in Japan.
The development of this application was carried out with the support of commercialization for the research and development venture of the New Energy and Industrial Technology Development Organization (NEDO) R & D venture support / seed period.
4. Presentation Contents: [Background Research]
The number of obese people in Japan (BMI ≧ 25 kg / m 2) is 13 million for men and 10 million for women. About 40% of male health checks and about 20% of female health checks reported cases of having a fatty liver that were not related to alcohol intake. Along with the westernization of meals, the number of fatty liver patients are increasing year by year, and the current total number of people in Japan effected is estimated to be around 10 million. Among them, NASH patients who are at risk for developing liver cirrhosis or liver cancer in the future is considered to be about 2 million. It is believed that this may have a high influence on their ability to have a healthy life span. Patients diagnosed with NASH in Japan and overseas have been shown to be at risk for not only cirrhosis and liver cancer but also higher rates of death due to myocardial infarctions etc.
There have been reports in the past that pioglitazone and vitamin E, which are therapeutic agents for diabetes, have the potential to temporarily improve the condition of the liver of NASH patients, but the long-term safety and effectiveness of such treatments has not yet been confirmed. There is currently no established pharmaceutical treatment for NASH. The most reliable method of treatment with level A evidence shown in the current guidelines requires weight loss through diet and exercise therapy with a specific target weight reduction of 7% of the patient’s original weight. However, even if diet and exercise therapy are carried out within the time limit of general outpatient clinical practice, in many cases, the effect of the treatment is often poor, and this solution hasn’t shown improved results.
Therefore, the Department of Gastroenterology, University of Tokyo Hospital, in collaboration with CureApp, Inc., will continue treatment by providing guidance on things like diet, exercise, behavioral therapy, etc., personalized for individual patients to patients on top of conventional outpatient treatment for the purpose of treating NASH. We have developed the first application of its kind in the world and are beginning clinical research. In the United States, there have been reports of confirmed efficacy with continuous treatment intervention using a smartphone application for diabetic patients. There are also cases in which patients use apps prescribed by physicians in clinical practice. Treatment applications are materializing.
[Contents of Clinical Research]
Patients of the University of Tokyo Department of Medicine Hospital Gastroenterology Department outpatient department who meet the registration criteria are explained by a doctor the details of the research project and the requirements of their participation. All patients have informed consent.
In the future, we are planning to conduct massive clinical research in order collect data for use with many patients, however we started with a more feasible preliminary survey conducted on a small number of patients. As we conducted the research, we could not participate normally via our first outpatient clinic, but from the special link (※) available on the homepage of the Department of Gastroenterology Hepatic Cancer Treatment Team, The University of Tokyo. We entered data into the input form and asked questions to patients from the research secretariat to those outpatients who were confirmed to have registered in the clinical trial, after conducting the examination. We planned for participation in this event as follows. Patients should use their personal smartphone for about 10 to 15 minutes a day to enter data. From the data collected from the treatment application via individual patient input, and from the individually distributed video and text we will recommended a course of treatment through medical guidance. The doctor in charge at the time of outpatient treatment evaluates the effectiveness of treatment and the information gathered by the treatment application regarding the progress of daily treatment. The program that results from these considerations is used for outpatient clinical care.
This clinical study was planned to meet the ethical and scientific standards required for clinical research and approved by the ethics committee of the University Hospital affiliated hospital.
The clinical research registration form is available at: http://goo.gl/m91zNJ <QR code>
[Future Prospects] By conducting continuous treatment interventions with therapeutic applications, weight loss via the transformation of the awareness and behavior of patients can be achieved. If this cannot be maintained it is believed that it will lead to liver cirrhosis and liver cancer in the future. However maintaining weight loss may also lead to the prevention of other diseases caused by obesity. Due to this we also expect that successful use of the treatment will lead to a reduction of the high cost of medical expenses in Japan.
With the amendment of the former Pharmaceutical Affairs Law in November 2014, treatment applications became subject to regulations as software medical devices for the purpose of medical treatment and diagnostic assistance, thus it is appropriate for use in medicine. Now it must be evaluated. Currently, there are various health-related software devices available, but the therapeutic application used in this clinical study stands out from others as it has now begun to accumulate evidence for the future it is establishing. We are also considering obtaining regulatory approval as a new medical device for NASH which does not currently have a treatment solution.
5. Related URLs
The University of Tokyo Hospital Department of Gastroenterology Department of Internal Medicine Liver Cancer Treatment Team (Clinical Study Office) Homepage http://park.itc.u-tokyo.ac.jp/livercancer/
CureApp Inc. Website
http://cureapp.co.jp/
6. Inquiries from News Organizations: <Inquiries About Research>
The University of Tokyo Department of Medical Sciences Hospital Inspection Dept.
Special clinician (gastroenterological physician) Masaya Sato
Telephone: 03-3815-5411 (ext. 33068) E-mail: satoma-int@h.u-tokyo.ac.jp
The University of Tokyo Graduate School of Medicine Graduate School of Gastroenterology
Ryosuke Kenseishi Specialized lecturer
Telephone: 03-3815-5411 (ext. 33068) E-mail: tateishi-tky@umin.ac.jp
CureApp will begin clinical research using a therapeutic application dedicated to NASH (Non-Alcoholic Steatohepatitis) developed in collaboration with the Department of Gastroenterology of the University of Tokyo Hospital.
1. Presenter:
Masaya Sato: Specialized Clinician (Department of Internal Medicine, Gastroenterology), Department of Inspection Dept., University of Tokyo School of Medicine Affiliated Hospital
Ryosuke Koseishi: Graduate School of Medicine, University of Tokyo Graduate School of Medicine, Graduate School of Gastroenterological Sciences Guest Lecturer
Kazuhiko Koike: Graduate School of Medicine, Kyoto University Professor of Gastroenterology
2. Presentation Points:0
NASH ◆ At the University of Tokyo Medical School Hospital the world's first NASH (Non-Alcoholic Steatohepatitis: Non-Alcoholic
Steatohepatitis) medical application based treatment will begin clinical research using our special treatment application. ◆ Patients can receive medical guidance properly, not only during their outpatient treatment but also through their daily lives. ◆ This study is expected to improve NASH pathology and life expectancy prognoses by providing medical guidance specific to a patient’s unique condition in real time for diet therapy, exercise therapy, behavioral therapy and other efforts.
3. Presentation Summary:
Masaya Sato: A special clinician of the Graduate School of Internal Medicine, The University of Tokyo Hospital, Ryosuke Kenseishi Special Lecturer:
We will begin clinical research on a therapeutic application dedicated to NASH jointly developed by Koike Kazuhiko's group and CureApp.
It is well known that NASH progresses to liver cirrhosis and liver cancer, and there are concerns that instances of NASH-based liver cancer will increase in the future.
NASH that develops due to a history of obesity prevails in Japan in about 2 million individuals (Preliminary estimates are about 10 million). However, there is currently no effective established treatment method other than nutritional guidance for weight reduction from consultation with a doctor. We are staying true to the efforts of individual facilities who use various forms of exercise. Moreover, it is actually difficult to conduct appropriate behavioral therapy on patients in the limited time frame of their outpatient checkups.
Therefore if an application that continually performs clinical guidance optimized for each patient, not including the time of outpatient examinations, that obtains positive results without significantly increasing the burden on both the patient and the medical staff, such an application, is expected to be a promising form of treatment of NASH
In addition, if treatment by weight loss through the improvement of a patient's awareness and behavior is achieved, not only may it be possible to prevent cirrhosis and liver cancer from developing, but may also provide prevention of other obesity caused illnesses ultimately reducing the cost of medical bills in Japan.
The development of this application was carried out with the support of commercialization for the research and development venture of the New Energy and Industrial Technology Development Organization (NEDO) R & D venture support / seed period.
4. Presentation Contents: [Background Research]
The number of obese people in Japan (BMI ≧ 25 kg / m 2) is 13 million for men and 10 million for women. About 40% of male health checks and about 20% of female health checks reported cases of having a fatty liver that were not related to alcohol intake. Along with the westernization of meals, the number of fatty liver patients are increasing year by year, and the current total number of people in Japan effected is estimated to be around 10 million. Among them, NASH patients who are at risk for developing liver cirrhosis or liver cancer in the future is considered to be about 2 million. It is believed that this may have a high influence on their ability to have a healthy life span. Patients diagnosed with NASH in Japan and overseas have been shown to be at risk for not only cirrhosis and liver cancer but also higher rates of death due to myocardial infarctions etc.
There have been reports in the past that pioglitazone and vitamin E, which are therapeutic agents for diabetes, have the potential to temporarily improve the condition of the liver of NASH patients, but the long-term safety and effectiveness of such treatments has not yet been confirmed. There is currently no established pharmaceutical treatment for NASH. The most reliable method of treatment with level A evidence shown in the current guidelines requires weight loss through diet and exercise therapy with a specific target weight reduction of 7% of the patient’s original weight. However, even if diet and exercise therapy are carried out within the time limit of general outpatient clinical practice, in many cases, the effect of the treatment is often poor, and this solution hasn’t shown improved results.
Therefore, the Department of Gastroenterology, University of Tokyo Hospital, in collaboration with CureApp, Inc., will continue treatment by providing guidance on things like diet, exercise, behavioral therapy, etc., personalized for individual patients to patients on top of conventional outpatient treatment for the purpose of treating NASH. We have developed the first application of its kind in the world and are beginning clinical research. In the United States, there have been reports of confirmed efficacy with continuous treatment intervention using a smartphone application for diabetic patients. There are also cases in which patients use apps prescribed by physicians in clinical practice. Treatment applications are materializing.
[Contents of Clinical Research]
Patients of the University of Tokyo Department of Medicine Hospital Gastroenterology Department outpatient department who meet the registration criteria are explained by a doctor the details of the research project and the requirements of their participation. All patients have informed consent.
In the future, we are planning to conduct massive clinical research in order collect data for use with many patients, however we started with a more feasible preliminary survey conducted on a small number of patients. As we conducted the research, we could not participate normally via our first outpatient clinic, but from the special link (※) available on the homepage of the Department of Gastroenterology Hepatic Cancer Treatment Team, The University of Tokyo. We entered data into the input form and asked questions to patients from the research secretariat to those outpatients who were confirmed to have registered in the clinical trial, after conducting the examination. We planned for participation in this event as follows. Patients should use their personal smartphone for about 10 to 15 minutes a day to enter data. From the data collected from the treatment application via individual patient input, and from the individually distributed video and text we will recommended a course of treatment through medical guidance. The doctor in charge at the time of outpatient treatment evaluates the effectiveness of treatment and the information gathered by the treatment application regarding the progress of daily treatment. The program that results from these considerations is used for outpatient clinical care.
This clinical study was planned to meet the ethical and scientific standards required for clinical research and approved by the ethics committee of the University Hospital affiliated hospital.
The clinical research registration form is available at: http://goo.gl/m91zNJ <QR code>
[Future Prospects] By conducting continuous treatment interventions with therapeutic applications, weight loss via the transformation of the awareness and behavior of patients can be achieved. If this cannot be maintained it is believed that it will lead to liver cirrhosis and liver cancer in the future. However maintaining weight loss may also lead to the prevention of other diseases caused by obesity. Due to this we also expect that successful use of the treatment will lead to a reduction of the high cost of medical expenses in Japan.
With the amendment of the former Pharmaceutical Affairs Law in November 2014, treatment applications became subject to regulations as software medical devices for the purpose of medical treatment and diagnostic assistance, thus it is appropriate for use in medicine. Now it must be evaluated. Currently, there are various health-related software devices available, but the therapeutic application used in this clinical study stands out from others as it has now begun to accumulate evidence for the future it is establishing. We are also considering obtaining regulatory approval as a new medical device for NASH which does not currently have a treatment solution.
5. Related URLs
The University of Tokyo Hospital Department of Gastroenterology Department of Internal Medicine Liver Cancer Treatment Team (Clinical Study Office) Homepage http://park.itc.u-tokyo.ac.jp/livercancer/
CureApp Inc. Website
http://cureapp.co.jp/
6. Inquiries from News Organizations: <Inquiries About Research>
The University of Tokyo Department of Medical Sciences Hospital Inspection Dept.
Special clinician (gastroenterological physician) Masaya Sato
Telephone: 03-3815-5411 (ext. 33068) E-mail: satoma-int@h.u-tokyo.ac.jp
The University of Tokyo Graduate School of Medicine Graduate School of Gastroenterology
Ryosuke Kenseishi Specialized lecturer
Telephone: 03-3815-5411 (ext. 33068) E-mail: tateishi-tky@umin.ac.jp
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