An insulin pump that reports sugar levels to diabetics in real time

Reduces the risk of loss of consciousness • Reduces the risk of fetal death in diabetic mothers • Constitutes a revolution in the treatment of diabetes - allows diabetics to balance without fear

At a press conference held yesterday (Wednesday) in Tel Aviv, Medtronic Minimed announced an automatic system that continuously checks the blood sugar level of diabetics. The system warns of the sugar status (level and trend) and the patients can use this data and inject themselves with insulin (with a pump, which is also part of the system, although it is also possible to do it manually without it), or alternatively eat something to raise the sugar level if it is too low, To prevent fainting due to hypoglycemia.

However, the major drawback of the device is its price. It is not included in the health basket and the sensor, which must be replaced every few days and costs hundreds of shekels. The heads of the Israeli Society for Juvenile Diabetes who participated in the press conference announced that they had contacted the Health Basket Committee and requested funding for the device for 200 high-risk patients (mostly pregnant women or those seeking to conceive and children), at a cost of NIS 4 million.

Maintaining the sugar level values

Fear is a heavy shadow that accompanies diabetics every day from the moment the disease is diagnosed. The main ambition of patients with the disease is to maintain sugar levels as close as possible to the norm, but few diabetics reach it. Diabetics are anxious about sharp drops in sugar values ​​that end in loss of consciousness, and about sharp increases in sugar values ​​that put them at risk of serious diseases. Every action and feeling can cause extreme fluctuations in sugar values ​​and affect the balance: mental stress, food and drink, and physical activity, and with the means that have been available to them until now, diabetics have received a partial and spot-on picture of the state of diabetes.

In addition, diabetes is a complex disease to treat. Too close a balance leads to hypoglycemia (a sharp drop in sugar values ​​that causes blurred vision, fogginess, weakness and confusion to the point of loss of consciousness). The fear of hypoglycemia accompanies diabetics every day and they protect themselves from it by "jumping" the sugar values ​​and maintaining high values. Many diabetics suffer from unconscious hypoglycemia, especially at night.

The populations especially exposed to risk are:
1. Patients with type 1 diabetes, also known as juvenile diabetes, especially the patients who suffer from sharp and unexpected drops in sugar values.
2. Pregnant women with juvenile diabetes, for which any fluctuation in sugar levels may affect their health and the health of their fetuses and cause early miscarriages, births of fetuses with defects and death of fetuses in the womb.

Today, with the launch of a new technology that mimics the action of the pancreas in the body of a healthy person, diabetics can breathe easy.

איך זה עובד?
288 automatic sugar tests per day
The integrated insulin pump "Paradigm" 522/722 (Paradigm Real Time) reads the sugar levels 288 times a day, every 5 minutes, and presents diabetics with up-to-date data in real time. To this day, diabetics inject themselves 4-10 times a day with the traditional sugar uniform. From now on, a special sensor inserted into the subcutaneous layer will automatically transmit data to the pump monitor. Until the development of continuous monitoring technology, diabetics knew what their sugar level was, as of a given moment, but they had no idea whether their sugar level was rising or falling drastically, meaning whether they were in a situation that put them at risk.

In order to avoid dangerous situations, for the first time the diabetic is presented with rising and falling trends in sugar levels. For the first time, the diabetic receives "safety alerts" for extreme abnormalities in the sugar values, which allow him to translate the information into treatment decisions, and to take quick and precise action to balance the sugar levels. Similar to a healthy pancreas, the pump delivers insulin to the diabetic's body day and night. The pump is equipped with a smart calculator, the computer for the diabetic which is the exact amount of insulin required to balance the sugar levels. In this way, the diabetic avoids mistakes well known to diabetics - injecting too much or too little insulin.

Diabetics who use the integrated pump testify that, for the first time, they feel free from the frustration that accompanies them in their struggle to balance their disease and are empowered thanks to a tool that provides them with constant essential information. According to them, they manage their disease and feel that they have regained control over their lives.

Research results: a tight balance reduces diabetes complications by 60%
Thanks to the integrated pump, the deadly roller coaster characterized by rises and falls of sugar values ​​that cause serious diseases will stop: cardiovascular diseases, blindness, kidney failure up to loss of function and limb amputations. One of the well-known studies: the DCCT Diabetes Control and Complication Trial examined over the years the effect of sugar levels on the complications of the disease. In the study, it was found that among the group that received intensive treatment for a strict balance of sugar levels, there was a 60% decrease in complications related to diabetes. The difference between the hemoglobin A1c levels (the index that reflects the balance of diabetes in the last three months) of the two treatment groups - the one that received close treatment and close control of blood sugar levels, versus the conventional treatment group that was treated less closely, with few fasting sugar tests, was 1.7% less in the intensive treatment group. To explain the meaning of each one percent decrease in hemoglobin A1c values ​​for the patient, is a 40% decrease in the risk of suffering from serious diseases, which are the result of unbalanced diabetes.

Dr. Ohad Cohen, diabetes clinic at Sheba Hospital, Tel Hashomer: "The integrated pump will enable a revolution in the treatment of type 1 diabetes patients both from the perspective of the patient and the medical teams. The new technology will make it possible to reach a closer balance, which means fewer complications, such as hypoglycemia, and will allow diabetics, who are afraid of sugar drops, to reach a balance with a sense of security and without fear."

The Juvenile Diabetes Association in Israel will fight this year for the inclusion of continuous sugar reading technology (transmitter and sensor) in the health basket

Shulamit Noss, chairman of the Association for Juvenile Diabetes in Israel: "The association will struggle this year to find funding for this technology. Instead of treating serious diseases and the complications of diabetes, I call on the Ministry of Health, the Ministry of Finance and the health funds to allocate resources to preserve the lives of diabetics today."

The integrated pump was approved by the FDA, CE in Europe and AMR in Israel. The pump, without the sensors and transmitters required for the continuous cooling of the sugar, is included in the health basket. The cost of treatment with the continuous monitoring technology per year (transmitter and sensors) - NIS 30,000.

The integrated pump was developed by Medtronic Minimed, which is represented in Israel by the Agnetac company.

Monitoring sugar levels in diabetic children using continuous reading technology

Dr. Roital Nimeri, the Institute of Endocrinology and the National Center for Juvenile Diabetes, Schneider Pediatric Center presented at the press conference the results of a pan-European study in which 18 of the institute's patients also participated. The study, which lasted for 3 months and asked to check whether diabetic patients with moderate metabolic balance (glycated hemoglobin above 8%) can improve the diabetes balance with the help of continuous reading technology. The study included 162 patients, of which 81 were children, who were randomly divided into three treatment arms: a group of patients treated with daily monitoring, a group treated with prolonged monitoring for 3 days once every two weeks, and a control group. As part of the study, an improvement in metabolic balance was found in the group of patients who used the continuous reading technology. The improvement is in direct proportion to the duration of use of the sensor. The patients reported on the changes they made in their lifestyle and diabetes treatment in light of the data obtained from the continuous reading device and a sense of security in their diabetes treatment resulting from the alerts they received from the device, which warned them of hypoglycemia events

high risk pregnancy

Prof. Moshe Hod, director of the high-risk pregnancy unit in the women's and maternity department at Beilinson Hospital, said that the higher the sugar level in a woman's blood, the greater the risk of spontaneous abortions, fetal defects and medical problems for mother and fetus. "Many studies have pointed to the connection between high levels of glucose among mothers in the first trimester of pregnancy, at the stage when the fetal organs are developing, and a high rate of spontaneous abortions and severe birth defects. Birth defects, 3 times more common in mothers suffering from juvenile diabetes (type 1), and are the leading cause of fetal death and infant morbidity. "

"In the last 25 years, many studies have been published indicating that optimal diabetes balance leads to the birth of healthy babies at a very similar rate to babies of non-diabetic mothers, although not at the level of the population of healthy pregnant women."
"In order to avoid prolonged hospitalizations, loss of pregnancies, loss of working days and lifelong care for a child with malformations, diabetics and the medical teams must maintain close and continuous monitoring of blood glucose values ​​before and during pregnancy and bring about an optimal balance of sugar values ​​through insulin injections. The insulin pump, which is integrated with a sensor for continuous reading of the sugar values, is a breakthrough technology, which constitutes a real revolution in the possibility of diabetes monitoring. The information allows the diabetic to manage her disease based on real-time information and thus reach a much better balance of diabetes before and during pregnancy. For the first time, it is possible to significantly reduce the rate of abortions, birth defects and stillbirths in women with type 1 diabetes."

First person journalistic story

One of the participants told her personal story. It was the journalist Chen Kouts Bar, a juvenile diabetic who has experienced loss of consciousness many times, and she is afraid of what is expected of her when an unsuccessful fall could cause her to fall cognitively. Cotts-Barr said that the new device, to which she has been connected since January of this year, has changed her life and allows her to live a normal life and not to fear the rise of her sugar level, she can even enjoy iced coffee and food that is not intended for diabetics. However, she accepts the cost, about NIS 2,500 per month, which she finances from her father's compensation money that he receives from the Germans as a Holocaust survivor. She also believes that just as technologies that are an improvement of existing systems are included in the health basket (for example pacemakers or imaging devices), the product that is a technological improvement of the insulin resource should be included.

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