MiniMed 670G

Main article: Medtronic MiniMed insulin pump series

MiniMed 670G is an artificial pancreas that combines an insulin pump and a continuous sugar monitoring system. The device measures blood glucose levels every five minutes and injects insulin as needed. MiniMed 670G uses a sensor with a protruding needle that penetrates under the skin and measures insulin levels. In its place on the human body, it is held with a sticky substrate. The second component of the system is an insulin pump, most commonly worn on the side of the abdomen, which has a tube connected to a catheter to introduce insulin into the body. All operations are carried out automatically, which reduces the risk of developing deadly critical conditions.

MiniMed Insulin Pump Image 670G

MiniMed 670G is not a perfect device, since patients need to calibrate every 12 hours, replenish the insulin tank every three days, make adjustments depending on physical activity that reduces blood glucose levels, etc. However, compared to the number of procedures that a type 1 diabetes patient should carry out now, MiniMed is 670G a significant improvement in the quality of life.

Although the emergence of a system such as MiniMed 670G is a big step forward, patients are still waiting for a fully automatic artificial pancreas, which will not require any interventions from the user, including input for food and exercise.

2022: Medtronic warned of marriage in its insulin pumps. They can be hacked remotely

In mid-September 2022, Medtronic issued an urgent medical device adjustment notice to warn of potential problems with some MiniMed automatic insulin delivery systems.

The notice applies to MiniMed 600 series insulin pumps (MiniMed 630G and 670G). Affected devices also include the Guardian Link 3 transmitter, Contour Next Link 2.4 blood glucose monitor and CareLink USB.

MiniMed 670G

Medtronic recently identified a potential problem during internal testing of these devices. Under certain circumstances, unauthorized access can disrupt communication between components of the pump system. In order to obtain such access, it is necessary that a nearby person has access to the pump while it is mating with other components of the system. This cannot be done via the Internet.

The company said that as of September 21, 2022, it had no evidence that such an issue had occurred. Similarly, the FDA said it was not aware of any reports related to this cybersecurity vulnerability. However, if unauthorized access occurs, it can be used to administer too much or too little insulin. An unauthorized person may inject an unintended bolus or slow/stop the insulin supply.

In these cases, too much insulin can lead to hypoglycemia (low blood sugar), which can cause seizures, coma, or death. Too little insulin can lead to hyperglycemia (high blood sugar), which can lead to diabetic ketoacidosis (DKA). The US Department of Health said it is working with Medtronic to identify, inform and prevent adverse events related to the cybersecurity vulnerability.

The Medtronic notice included necessary actions and recommended precautions for users. The company instructed users to disable the "Remote Bolus" feature on the pump if it was enabled. The notification recommends that users always keep the pump and the system components connected to it under their control. In addition, users should be alert to notifications, alarms and alerts and cancel any boluses that they or their care partner have not initiated.

Users should not confirm requests for remote connectivity or other remote activities unless initiated by themselves or their care partner. They should not connect third-party devices to the MiniMed pump.^[1]

2020: Medtronic recalls defective insulin pumps over 'serious' problem

In mid-February 2020, Medtronic recalls hundreds of thousands of Minimed insulin pumps due to the threat to patients' lives. In the US market alone, 322,005 MiniMed 630G and 670G pumps are being recalled, which the FDA regulator said have a "serious" problem. Read more here.

2019

Medtronic recalls defective pumps that inject wrong dose of life-threatening insulin

In late November 2019, Medtronic warned patients using the MiniMed 600 series insulin pumps that due to a manufacturing defect, the tool could inject the wrong dose of life-threatening insulin. Defective equipment is being recalled.

Medtronic warned patients using MiniMed 600 series insulin pumps that a manufacturing defect could cause the tool to inject the wrong dose of insulin

In an appeal to patients, the company indicated that when the fixing ring breaks, the attachment of the insulin tank of the pump can weaken, and the incorrect attachment of the tank is dangerously excessive or insufficient insulin delivery, which can lead to hypoglycemia or hyperglycemia. Rupture of the locking ring can occur when the pump falls or hits a hard surface. The problem concerns the MiniMed 630G (model MMT-1715) and MiniMed 670G (model MMT-1780) insulin pumps.

A Medtronic spokesperson told the StarTribune that the company received at least one report of a patient being hospitalized because of a fixation ring problem and one fatality report that may be related to the same problem.

Medtronic advised patients to stop using the device if the reservoir does not lock in the pump or if its mount is loose, damaged or missing. The company also suggested that patients check the locking ring for possible damage and make sure the reservoir is properly secured. All patients should check the fixing ring regularly. The company also said it had notified the US medical regulator of the issue.^[2]

Medtronic insulin pumps do not function in airplanes

In mid-July 2019, Medtronic warned patients that MiniMed 600 series insulin pumps could stop acting on the plane or in other situations with a rapid change in air pressure. The identified problem concerns more than 189 thousand devices used around the world. Read more here.

Patients reject uncomfortable MiniMed pumps 670G

At the end of March 2019, a study was published that highlighted the problems of using the MiniMed automated insulin pump 670G manufactured by Medtronic. Representatives of the company replied that over the past time since the study, they have improved the system and made many changes, which, according to them, solved some of the problems.

However, doctors at Boston Children's Hospital reported that nearly a fifth of participants in the MiniMed 670G study stopped using this insulin pump within months of her appointment, citing its unsatisfactory technical characteristics.

Patients complain about uncomfortable Medtronic insulin pumps and refuse them

The Medtronic MiniMed insulin pump 670G designed to automatically track and control glycemia by measuring blood glucose concentration every few minutes and automatically administering insulin as needed. This automated insulin delivery system first received regulatory approval in September 2016.

In response to the Boston Children's Hospital study, Medtronic reported that developers have updated software in the MiniMed 670G transmitter, which sends sensor data directly to the insulin pump. When the system was first released to the market in 2017, it was equipped with an additional level of safety and constantly requested permission from the patient to assess glycemic levels. The company subsequently automated this process to improve the quality of service. Medtronic believes that the problem arose at this level.

To improve the quality of care, we have created software that eliminates all additional safety checks without compromising patients. All MiniMed 670G pumps shipped today are equipped with an advanced transmitter, and we have begun replacing the transmitter in models that have caused difficulties for users, the company said in an official statement.[3]

2017

Shortage of components for production

In August 2017, Medtronic reported problems with the supply of  MiniMed 670G automated insulin syringes for diabetics. The company faced a shortage of sensors used in this equipment.

We are talking about sensors for monitoring glucose in patients with diabetes mellitus, which use Medtronic insulin pumps.

The growing demand for next-generation precision sensors - the advanced Enlite models in international markets and the Guardian Sensor 3 in the United States - has exceeded our production capabilities, "said Omar Ishrak, Chairman of the Board of Directors and CEO of Medtronic, during a conference on the publication of the company's quarterly reports. - We accelerated the implementation of last year's plans to increase the production of sensors. But those production lines won't be ready for commercial launch until the fourth quarter. By this time, we expect to increase capacity to the level required to meet the rapidly growing demand for sensors. In the meantime, we continue to prioritize sensor deliveries to current customers. In the short term, this situation will reduce revenues from sales of new medical systems.

MiniMed 670G

The company also stressed that the limited production of sensors is not associated with the workload of factory capacity, product quality or production problems. Strong sales of sensors of non-standard sizes require expansion of production capacity.

By August 2017, Medtronic is awaiting approval from the Food and Drug Administration to use new equipment used in sensor manufacturing. After obtaining the necessary certificates, the company expects to increase the production of products for diabetics.^[4]

Start of sales for patients aged 14 and over

In June 2017, Medrtonic announced the launch of the MiniMed 670G device, which automatically detects blood glucose levels and injects the right amount of insulin.

We have developed an essentially more intelligent insulin pump that makes it easier to solve problems in the fight against diabetes that can be inexorable and debilitating, "said Alejandro Galindo, president of the intensive insulin therapy division of Medtronic Diabetes Group.

MiniMed 670G automatically detects blood glucose and injects the right amount of insulin

According to him, the reaction of the community of people with diabetes to MiniMed was 670G positive. This was confirmed by Jennifer Lynn Sherr, associate professor of endocrinology at the Yale School of Medicine:

The MiniMed 670G system has proven its ability to change the lives of many patients for the better. We are really excited to be able to provide it to many others who she will help. We've seen this system positively impact not just patients but those caring for them as MiniMed 670G develops a new sense of security. The constant vigilance this chronic disease imposes on both patients and their families will now weaken as caregivers have a new level of independence and freedom.

MiniMed 670G addressed to a Type 1 diabetic patient, which is an autoimmune disease where the body erroneously destroys the cells responsible for insulin production. This hormone helps the body absorb and process sugar. Insulin is produced by the pancreas, so MiniMed is 670G called an artificial analogue of this organ.

MiniMed 670G is intended for patients aged 14 and over. However, Medtronic continues to test the device by June 2017 and is going to conduct clinical trials to adapt the device for children from 7 to 14 years old.^[5]

Serial trials by patients

In March 2017, Medtronic began testing the MiniMed 670G autonomous insulin pump among its customers, and also clarified the timing of the start of sales of the product.

American medical institutions included in the Priority Access Program were the first to test the MiniMed 670G artificial pancreas. First, users of the MiniMed 630G model can get it. Then access to the new product will be opened to owners of other systems (for example, MiniMed 530G or Revel) who want to switch to more modern equipment.

MiniMed 670G

Registration in the priority access program is open until April 28, 2017. A full-scale launch of the product, which is already approved for sale in the United States, is expected in June.

Medtronic does not disclose the cost of MiniMed 670G, but claims that prices for diabetes patients and medical institutions will remain at the level of similar pumps of the manufacturer. For example, in retail MiniMed 630G costs about $6-9 thousand, but the final price for the user will depend on the insurance company and the terms of the contract.

As noted by diaTribe, the long period during which the automated insulin delivery system is being tested and the phase of customer training before the start of serial sales suggests that the launch of such equipment is a big and difficult task even for such a large company as Medtronic. Since the MiniMed 670G represents the first hybrid closed-loop insulin injection system to hit the mass market, it is essential to prepare patients for the innovations.

2016: MiniMed 670G presentation and US approval

At the end of June 2016, Medtronic announced the timing of entering the mass market for artificial pancreas, a device for the automatic delivery of insulin to type 1 diabetics.

The device, called MiniMed 670G, is an insulin pump controlled by a closed-loop system using real-time data from a continuously operating blood glucose sensor. A device the size of a smartphone is not sewn into the human body, but is attached to clothes.

MiniMed 670G continuously monitors blood sugar levels and allows you to adjust the treatment of diabetes with special pre-installed software. The device can display all information on the screen of a smartphone or tablet wirelessly.

In late June 2016, Medtronic submitted an application to the Food and Drug Administration (FDA) for approval to use MiniMed 670G in American hospitals and clinics. The manufacturer plans to release this artificial pancreas in 2017. Its cost is not called.

Before contacting the FDA, Medtronic tested MiniMed 670G on 124 patients who used this device for 84% of the total time.

They were at home, living an ordinary life. No one watched them remotely. The device works and adjusts independently, "said Francine Kaufman, head of development for diabetics at Medtronic.

In late September 2016, the U.S. Food and Drug Administration (FDA) approved the MiniMed 670G device. The MiniMed device 670G approved for patients aged 14 and over. Experts believe that the new device could bring Medtronic about $1 billion a year.

According to experts, the cost of MiniMed 670G will be about $5-8 thousand plus the cost of additional devices and insulin, which will require several thousand more a year. Medtronic is not expected to have a problem getting coverage. Therefore, we can expect that after 2017, when the device enters the market, the first buyers will be able to appreciate the convenience of its use.

According to JDRF, an organization conducting research to improve the lives of people with type 1 diabetes, the annual cost of this disease is about $14 billion. Thus, Medtronic has the opportunity to gain a share of this market, especially given that the main competitors, DexCom and Johnson & Johnson, will present such devices to the market no earlier than a year later^[6].

Medtronic started developing insulin pumps in 2001, then buying MiniMed for $3.7 billion. Subsequently, Medtronic unexpectedly received support in this direction from the FDA agency, which is often criticized for too strict requirements for equipment used in American healthcare. Because of this, many manufacturers of innovative medical devices prefer to implement their devices abroad.^[7]

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