Insulin pumps

Diabetes mellitus

• Diabetes mellitus

2024

World's smallest insulin plaster pump released

At the end of October 2024, Luna Diabetes introduced the world's smallest insulin pump to monitor glucose levels at night. The Luna system in the form of a patch works in conjunction with a continuous glucose monitoring device, which allows you to calculate and inject fast-acting insulin microdoses during sleep, preventing unnecessary fluctuations both in that and in the other direction. Read more here.

An insulin pump in the form of a patch was released

On September 3, 2024, Embecta introduced a one-time insulin delivery system for adult patients with type 1 and type 2 diabetes. The article is made in the form of a patch adhering to the skin. Read more here

In the Moscow region for 1 billion rubles launched the production of insulin pumps and glucose monitoring sensors

In early September 2024, it became known that in the Moscow region, the Diakont company completed a project to launch the production of insulin pumps and glucose monitoring sensors. The production line was opened at the KorolevPharm plant in Korolev, and the total investment in the construction and modernization of the enterprise amounted to about ₽1 billion. This project has become part of the import substitution program in the field of medical technologies and is aimed at creating a full cycle of production of vital medical devices in Russia. Read more here

2022: Medtronic unveils insulin pump whose consumables need to be changed once a week

On November 15, 2022, Medtronic announced the release of the Medtronic Extended infusion kit, the first insulin pump capable of functioning for seven days without the need to replace consumables. For comparison: for ordinary devices, this indicator is two to three days. Read more here.

2018: Insulin pumps become the most problematic medical devices

In early December 2018, the Associated Press and the International Consortium of Journalists presented the results of their research, according to which insulin pumps turned out to be the most problematic medical devices in the last ten years.

Insulin pumps are used by hundreds of thousands of diabetes patients around the world, with children making up a huge proportion of these patients. Together, insulin pumps and their components have become the most common cause of complaints about malfunctions, injuries and deaths according to the US Food and Drug Administration database. Insulin pumps are inferior only to femoral implants and only in relation to cases of harm to health, without taking into account malfunctions. But if each case of side effects during implantation of the femoral joint is carefully documented and studied, then problems with insulin pumps do not always find a solution.

Insulin pump

Medical device manufacturers and many experts argue that insulin pumps are safe devices that are designed to help diabetics and improve their quality of life. Most often, they consider the patient's mistake to be the cause of the problem, noting that pumps are complex devices, and their use requires special training.

According to regulatory authorities, "diabetes mellitus is a dangerous disease, and patients with diabetes mellitus relying only on insulin injections put themselves at unjustified risk." Regulators monitor the safety of medical devices, monitor the elimination of problems and try to convince manufacturers to develop safer projects, but companies do not always follow the recommendations.

From 2008 to 2018, Medtronic was forced to recall insulin pumps 20 times and participated in more than 100 lawsuits related to the malfunction of these devices. Medtronic said it monitors the safety of its products through clinical trials and observational studies and that "the findings support the safety and efficacy of our insulin pumps, which help hundreds of thousands of patients." The company declined to answer other questions.

The use of insulin pumps is thought to be safer than the traditional insulin injection treatment. However, a 2015 study found that 40% of users experience any problems with insulin pumps, with some, especially often children, requiring hospitalization in such cases. The study also noted: "Notably, complaints about insulin pump malfunctions are not declining, although companies claim to be implementing all new technological advances."

Regulatory data cannot explain the reason for this high prevalence of adverse effects. Many reports of malfunctions filed by physicians, manufacturers, and patients do not list critically relevant information, leaving regulators unable to assess the validity of the complaint.

For example, Medtronic almost never reports the code of a device-related problem, because manufacturers are allowed not to provide this code if the information is unknown. As a result, in more than 150,000 adverse event reports related to various Medtronic medical devices, the problem code was listed only in 2% of cases, most often meaning "The device reflects incorrect data."

Regulators note that since 2013, the number of complaints about insulin pumps has decreased, which is likely due to the introduction of stricter controls and increased user awareness.^[1]

2016: Vulnerability in Johnson & Johnson insulin pumps threatens thousands of sufferers

In early October 2016, Johnson & Johnson warned diabetics and doctors that the company's OneTouch Ping insulin pumps were vulnerable to cyber attacks. The lives of tens of thousands of people may be at risk, but the manufacturer says that the alarm should not be sounded. Read more here.

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