Release date: 2014-09-30
Although the use of insulin pumps has been around for a long time, the review of pump safety has not received sufficient attention. At the press conference on the third day of the European Association for the Study of Diabetes (EASD), Professor Boulton said that despite the American Diabetes Association (ADA), the American Association of Diabetes Educators (AADE), and the UK National Health and Clinical Optimization Institutions such as the Institute (NICE) have issued guidelines or statements on the use of insulin pumps, but they involve pump safety, especially for pump safety reviews. Professor Boulton said that the current review of the safety of insulin pumps, there are some regulations before the market, but most of the clinical efficacy and safety reports are from clinical researchers, and post-marketing safety and effectiveness monitoring The data is very limited and the data is not public to the public. So, how can the insulin pump be safer? And listen to the opinions of several experts at the EASD annual meeting.
Insulin pump safety can not be ignored
Professor Boulton said uninterrupted insulin infusion interruptions or malfunctions can be a serious hazard to patients. A survey of 640 new insulin pumps produced by four companies in 2001-2007 by Diabetologia in 2009 showed that 36% of products had problems and 6.5% of insulin pumps were mechanically faulty. It must be exchanged. Insulin pump failure, infusion set blockage, user error, etc. are the main causes of adverse events.
It can be seen that the adverse events caused by the use of insulin pumps are actually not uncommon, and should definitely attract the attention of the government, doctors and the public.
Insulin pump safety statement is imperative
One of the makers of the ADA/EASD insulin pump joint statement, Professor Anne Peters of the University of Southern California, said that in the past few years, every expert in the joint statement development team has made a lot of efforts, the purpose is hope By establishing such a statement, the device safety is strengthened to ensure that the insulin pump can be used safely and effectively for the treatment of diabetic patients.
As a clinician for diabetes specialists, Professor Peters is exposed to patients who use diabetes treatment devices every day. Even on weekends, she receives calls from patients, some of them because of device problems. Therefore, when he was invited to participate in the formulation of the joint statement, Professor Peters accepted and put into work. By looking up information and talking to representatives of the US Food and Drug Administration (FDA) and manufacturers, Professor Peters found that clinical data on the long-term use and safety of insulin pumps in the United States is actually very limited and reported by producers. Adverse events are also different. The FDA's open access to the manufacturer's and user facility equipment experience (MAUDE) database reports vary widely from product to manufacturer.
Analyze US and European practices and develop joint statements
John Petrie of the University of Glasgow, United Kingdom, as one of the makers of the European Regional Joint Statement, said in his report that in the United States, the FDA has listed insulin pumps as Class 2 devices, and the approval of these devices relies mainly on proving their equivalence. Efficacy testing of existing devices rather than clinical studies, and many clinical studies on new devices are small, and analysis of human factors is very limited. Most adverse events are reported to the FDA by the manufacturer, but the methods of reporting and classification have not been standardized and there is a lack of long-term systematic assessment of the device in the real world. In Europe, pump products are licensed for sale across member states by obtaining the “CE Mark†from the “designated agencyâ€.
Professor Petrie said that EASD believes that despite the “breast prosthesis safety incidentâ€, the supervision of medical devices is now much stricter than before, but far-reaching changes still depend on new legislation, and EASD is also necessary and Together, the ADA has developed such a joint statement to ensure patient safety.
The ADA/EASD Joint Statement will focus on safety review and patient education
Pay attention to insulin pump safety review
In an interview with this reporter, Professor Peters said that the biggest difference from the previous guidelines or recommendations in this joint statement is that the ADA/EASD joint statement will focus on the safety review of insulin pumps. There will be no updates on academic content such as indications and contraindications.
Pay attention to the education of patients with insulin pump therapy, family doctors play an important role
Professor Peters believes that patient misuse is the most important cause of insulin pump safety. Therefore, patient education is very important to protect the safety of users. In the United States, any clinician has the right to prescribe insulin pumps.
Professor Peters believes that it is very important for family doctors to learn the professional insulin pump use knowledge in order to better guide patients. When asked if there are other factors that may affect the safety of the insulin pump, Professor Peters believes that the age of the patient, the level of education, etc. will have an impact, but it has little to do with the type of insulin infused.
Professor Petrie affirmed Professor Peters' answer. Professor Petrie told this reporter that patient education is indeed an important part of ensuring the safety of insulin pumps, but he does not agree with every clinician in the United States has the right to prescribe insulin pumps. He believes that non-diabetic specialists have insufficient knowledge of insulin and are not qualified to develop safe and effective treatment plans for patients. Therefore, the doctor's conditions should also be restricted to establish a certification standard for doctors, only the doctors who have passed the professional certification can be able to incorporate this treatment device into their medical practice.
The ADA/EASD Joint Statement is expected to be officially released in November
Professor Petrie also told reporters that the joint statement has been basically completed, and the expert group is still conducting a final review. The final version may be jointly published in Diabetes Care and Diabetologia in November this year. release.
â– Live interview
Strengthen the supervision of insulin pumps and correctly grasp the indications
Interview with Professor Ji Linong, Peking University People's Hospital
The Endocrinology and Metabolism Branch of the Chinese Medical Association and the Endocrine Branch of the Chinese Medical Association have developed the "Guidelines for the Treatment of Insulin Pumps in China" in 2009. This guide is the first in the world to systematically regulate the use of insulin pumps from a clinical perspective. This guideline in China clearly proposes recommendations for the treatment of insulin pumps, indications for treatment, precautions for use, and debugging of insulin pumps.
The use of insulin pumps is becoming more and more extensive, and its manufacture and production are also “flowering everywhereâ€. There are also manufacturers that design and manufacture insulin pumps in China. Insulin pumps are currently used for intensive treatment of type 1 diabetes, so their safety and effectiveness are particularly important, including the control of insulin dose. If the insulin pump is interrupted or the infusion is excessive during use, it will cause an adverse event. Therefore, it is important to strengthen the regulation of insulin pump quality, especially for patients who are used for a long time. However, the reality is that the regulation of treatment devices, including insulin pumps, is not as stringent as drug regulation.
In China, the clinical centers and doctors who can correctly master the insulin use technology are still limited. Therefore, it is still necessary for the diabetes specialist to grasp the indications and select the appropriate patients for treatment.
â– Domestic connection
Medical technology change, lifestyle change
Sun Zilin Wei Qiong, Department of Endocrinology, Zhongda Hospital, Southeast University
With the application of insulin pumps in the field of diabetes treatment, especially in patients with type 1 diabetes, patients are free to choose the time to eat, exercise, and sleep. Even if shift work or even travel across time zones, blood sugar is easier to control and life is more free.
However, due to the incorrect use of the insulin pump, the blockage of the insulin pump infusion line, and operational errors, serious clinical complications have become commonplace. In this context, ADA/EASD has developed a joint position statement on insulin pumps, suggesting a more robust audit system to ensure the safety and effectiveness of insulin pumps.
We also expect China's health supervision and management departments to also issue a sound audit system to conduct insulin pump-related clinical trials in the Chinese population, collecting information on the effectiveness and adverse events of insulin pumps and insulin infusion devices.
The application of insulin pumps should not only involve doctors, but also the participation of patients with good acceptability. At the same time, due to the changes in the field of diabetes treatment brought about by medical technology, we also need to explore new patient education models.
Source: Medical Tribune
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