Category Archives: Medical Device

Amazon sells exclusive diabetes and hypertension devices

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Amazon has launched an exclusive range of medical devices to help people manage their diabetes and hypertension at home.

The Choice devices, produced by the healthcare consultancy, Arcadia Group – which is not affiliated with the British fashion brand of the same name –include blood glucose monitors, blood pressure monitors and test strips.

Choice estimates that diabetes and hypertension affect up to 130 million Americans and hopes that its devices will help those afflicted to benefit from daily monitoring and progress tracking over time.

Conventional models and devices enabled with Bluetooth connectivity features will be available to buy, with pricing said to offer better value over devices that can be bought in pharmacies, according to the company.

Bob Guest, CEO of Arcadia Group, said: “The Choice brand is all about accessible wellness. Consumers no longer need to drive to a store to stand in-line and purchase their medical devices and supplies.

“Now, in the privacy of their home, consumers can review, compare and purchase the products of their choice. No insurance is required. Therefore, customers have the freedom of choice. They will no longer be told by their insurance company what brand they can buy. Choice is freedom.”

Guest went on to describe the products as “best in class and very affordable”. He said the company intends to incorporate voice-driven measurement interpretation as well as individualize wellness recommendations via Amazon’s Echo home speaker devices.

“This is all possible with Alexa, and will provide patients with a wellness experience not available until now,” he said.

Amazon is expanding its health-related products to capture more of the market. In June this year, the online retailer announced it is buying PillPack for $1 billion.

The move is expected to disrupt the pharmacy market by delivering pre-sorted medicines and refills to customers’ doors.

PillPack describes itself as “a full-service pharmacy that delivers a better, simpler experience for people managing multiple medications”. The firm liaises with doctors and also provides customer support.


Ultra-thin meta lens enables full colour imaging

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A meta lens developed by researchers at only one micron thick, has the ability to perform better than any compound lens currently available.

The first flat lens capable of correctly focusing a large range of colours of any polarisation to the same focal spot without the need for any additional elements has been developed.

Researchers at Colombia University School of Engineering and Applied Science developed the lens which is only a micron thick, but offers the performance of the best compound lens systems.

Associate Professor Nanfang Yu led the study and said: “The beauty of our flat lens is that by using meta-atoms of complex shapes, it not only provides the correct distribution of delay for a single colour of light but also for a continuous spectrum of light.

“And because they are so thin, they have the potential to drastically reduce the size and weight of any optical instrument or device used for imaging, such as cameras, microscopes, telescopes, and even our eyeglasses. Think of a pair of eyeglasses with a thickness thinner than a sheet of paper, smartphone cameras that do not bulge out, thin patches of imaging and sensing systems for driverless cars and drones, and miniaturised tools for medical imaging applications.”

The meta-lenses used standard 2D planar fabrication techniques similar to those used for fabricating computer chips. The researchers mention that mass manufacturing these meta-lenses should be simple as they are only one layer of nanostructure, and there is no need to go through the expensive and time-consuming grinding and polishing process.

“The production of our flat lenses can be massively parallelised, yielding large quantities of high performance and cheap lenses,” noted Sajan Shrestha, a doctoral student in Yu’s group who was co-lead author of the study. “We can therefore send our lens designs to semiconductor foundries for mass production and benefit from economies of scale inherent in the industry.”

“Our design algorithm exhausts all degrees of freedom in sculpting an interface into a binary pattern, and, as a result, our flat lenses are able to reach performance approaching the theoretic limit that a single nanostructured interface can possibly achieve,” Adam Overvig, the study’s other co-lead author and also a doctoral student with Yu, said.

“In fact, we’ve demonstrated a few flat lenses with the best theoretically possible combined traits: for a given meta-lens diameter, we have achieved the tightest focal spot over the largest wavelength range.”

The study was published by Nature’s Light: Science and Applications.


Novo Nordisk to launch connected insulin pens in early 2019

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Danish healthcare firm Novo Nordisk has unveiled plans to introduce new durable, connected insulin pens in early 2019.

The new NovoPen 6 and NovoPen Echo Plus connected insulin pens will replace the NovoPen 5 and NovoPen Echo insulin pens.

Novo Nordisk will commence the launch of new connected insulin pens in the first quarter of 2019. They are expected to be available in more than 50 countries.

The company expects to deliver connectivity for its disposable, pre-filled injection pens later in 2019.

Novo Nordisk commercial strategy and corporate affairs executive vice president said: “Our non-exclusive partnership strategy allows us to integrate with the various digital platforms that people are already using to help manage their diabetes.

“We firmly believe that this will help more people realise the full benefit of our innovative medicines and begin to ease the mental burden of diabetes treatment for those individuals.”

In parallel, the company has also entered into new partnership agreements with major diabetes technology firms such as Dexcom, Glooko and Roche to enable future integration of its connected pens with various digital health solutions.

As part of the deal with Roche, the partnership will incorporate insulin dosage information from Novo Nordisk’s connected pen technology into Roche’s open ecosystem, enabling to communicate with its digital diabetes management solutions such as mySugr.

The firm will also incorporate data from connected pen devices with its partners’ diabetes management solutions such as continuous glucose monitoring (CGM) systems and blood glucose meters (BGM).

Novo Nordisk will incorporate insulin dosing data with Dexcom CGM data in the coming years.

Roche diabetes care global head Marcel Gmuender said: “We believe in the tremendous benefits integrated digital diabetes management solutions can bring to people with diabetes, caregivers and healthcare systems as part of an open ecosystem and are excited to partner with Novo Nordisk to further drive innovation in this area.”

With marketing activities in more than 170 countries, Novo Nordisk is engaged in providing treatment solutions for obesity, haemophilia, growth disorders and other serious chronic diseases.


Biosense Webster enrolls and treats first patient in QDOT AF study

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Johnson & Johnson Medical Devices Companies announced today that Biosense Webster, a worldwide leader in the diagnosis and treatment of heart arrhythmias, has enrolled and treated the first patient in its QDOT AF Study.

The study will evaluate the delivery of high power, short duration ablation with QDOT MICRO, a novel radiofrequency (RF) ablation catheter for the treatment of paroxysmal atrial fibrillation (AF). The first AF patient was treated at OLV Hospital in Aalst, Belgium, one of eight centers in Europe part of the study that will be enrolling up to 50 patients.

AF is fast becoming one of the world’s most significant health issues – affecting 14 million people across Europe, the Middle East and Africa, as well as placing a critical burden on healthcare systems with up to 2.5% of total healthcare expenditure associated with the disease.

QDOT MICRO is a next generation catheter designed to treat AF in a catheter ablation procedure. In what will be a world-first, it delivers 90 watts of RF power in a four-second temperature-controlled catheter ablation session. Its optimized temperature control and micro-electrode technology is designed to provide more efficient and consistent lesion creation with advanced diagnostics, while simplifying the technique and reducing total ablation time.

“The concept of high power short duration ablation is novel and a potentially groundbreaking advancement for the industry,” said Tom De Potter, MD, FEHRA, Associate Director, Cardiovascular Center Department of Cardiology, Electrophysiology Section at OLV Hospital. “The new modality could result in improvements in clinical outcomes and procedural efficiencies and I look forward to further investigation.” Dr De Potter performed the first QDOT MICRO procedure, and is one of the study clinical investigators.

QDOT MICRO, which is only available for investigational use in Europe, is a steerable multi-electrode catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit RF current to the catheter tip electrode for ablation purposes. In addition to force-sensing technology, the catheter incorporates six thermocouple temperature sensors and three micro electrodes embedded in its tip.

“For over 20 years Biosense Webster has pioneered the development of atrial fibrillation treatment” explains Gabriele Fischetto (Vice President of Johnson & Johnson Cardiovascular Specialty Solutions in EMEA). “QDOT MICRO continues our commitment to deliver solutions that help clinicians heal more hearts and has the potential to increase the standard of treatment for paroxysmal atrial fibrillation”.


The future’s bright, the future’s digital in drug delivery

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As a new era of digital drug delivery is making headway, Dr Steven Wick, vice president, Product Development & Commercialisation, 3M Drug Delivery Systems, gives his thoughts on this digital future.

Across the drug delivery industry, there is currently a big movement toward digital enhancement of inhalation devices used by patients with asthma and COPD. With fewer step-change improvements in drug therapies, the pharmaceutical industry is now focusing its attention on drug delivery technologies as a means to improve compliance and therefore patient outcomes. The concept of digital health will allow us to properly equip patients to manage their condition and ultimately take control of their health.

A patient-centred model

A focal point of my career in pharmaceutical research and product development has been to drive innovation with a priority placed on improving patient outcomes. The technological advances that have made digital health possible are changing the landscape of device design to a more patient-centric model. Traditionally, drug delivery methods were designed without much consideration for the patient experience. Now, product developers and engineers are considering the challenges facing patients first. They use these insights to improve drug delivery device design, and by addressing patient challenges directly, they improve patient outcomes in the process.

A 2008 research report showed that up to 94% of patients make mistakes when using their inhalers, and these were the dry powder inhalers that were intended to be easier to use. None of the current devices are perfect, with up to 76% of patients struggling to use metered dose inhalers as well. Also, patients struggle to adhere to their medication schedule. When patients forget to dose themselves or inadvertently use their inhalation devices incorrectly, it doesn’t matter how great the drug is — it will be less effective.

Digital health is helping to solve these usability and adherence issues. For example, the 3M Intelligent Control Inhaler (ICI) is breath-actuated so that patients do not have to coordinate their in-breath with triggering of the device, and actuation is triggered at a low flow-rate and at the optimal point within the patient’s inspiration cycle, so that even patients with a severe condition and poor lung function can use the device.

Proprietary flow-sensing technology optimises the inhalation cycle and can detect whether a patient is inhaling the drug properly to ensure a full dose is received.

The device can connect to a smartphone or tablet for reminders and further instructions, and it can record data for sharing with a healthcare provider, to influence and inform healthcare decisions.

The focus of our efforts is to identify areas where drug delivery device technologies could add significant benefits to the patient and help manage costs for the provider and payer. In that vein, 3M has also developed a respiratory tracker to help patients identify and monitor triggers that result in breathing difficulty. The 3M Respiratory Tracker is not a drug delivery device but a consumer wearable designed to give the wearer a greater understanding of how their breathing patterns are related to environmental or weather-related considerations. It provides personalised forecasts tailored to an individual’s potential triggers in their local environment, while delivering dynamic tips and insights relating to breathing and activity.

Bringing the vision to life

One major factor that stands in the way of future advancements in the digital drug delivery space is cost. Billions of dollars per year are invested in digital health start-ups, and creative solutions are always on the horizon. However, these innovative inventions are struggling to move from the development lab to the pharmacy counter because we have yet to generate the pharmaco-economic models and the associated business cases required to create the necessity for these new digital drug delivery technologies.

To move forward, it is important for all parties involved: pharmaceutical companies, payers, providers, and patients, to understand how total healthcare costs will benefit from these new technologies. If a patient is receiving the right dose of medication at the right time on a consistent basis, one could surmise that the patient’s symptoms would be better managed and the patient would make fewer trips to the doctor’s office or emergency room. In the end, this will drive down overall patient costs and significantly reduce the financial burden on the healthcare system.

We must also consider the investment of time. For healthcare providers, helping patients is the ultimate goal. However, it’s typically the provider’s responsibility to teach his or her patient how to properly use the device, which means the provider must first be trained in how to use it. At 3M, we are sensitive to these factors and keep input from patients and providers at the forefront of all development stages. Our goal is a product that is as straightforward and beneficial as possible for both parties. Despite the bells and whistles that new technology allows, an inhalation device must be intuitive to use — plain and simple.

Moving forward

To stay aligned with this new era of drug delivery, organisations across the board have had to adapt. Here at 3M, we must now be more strategic in our R&D efforts than ever before. Because of the unique financial framework outlined above, we can no longer afford to innovate simply for the sake of innovation. Instead, we start by identifying a problem and then search for a feasible solution.

It is an exciting time to be involved in the drug delivery industry. I believe going digital will improve consistency in drug delivery, increase the efficacy of drug products, and reduce the opportunity for patient errors. I also believe it will offer providers and payers valuable new data to help them identify patients who need extra intervention, thus preventing a potentially catastrophic and costly event. Everything you can imagine doing, there is a possibility with digital health, which is why it will continue to be an unstoppable transition in the inhalation therapy for years to come.


Acoustic Cluster Therapy drives drug therapies to cancer cells

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Researchers are testing the use of pulsed sound waves to direct and focus cancer drug therapies.

Using in laboratory tests, researchers will analyse the effectiveness of a technology called Acoustic Cluster Therapy (ACT), a unique approach to targeting cancer cells by concentrating the delivery of chemotherapies, making them more effective and potentially reducing their toxicity.

South Korean manufacturers are developing clinically applicable hardware optimised for ACT, which the researchers at Translational Genomics Research Institute (TGen) will validate.

The researchers are using funding from Innovation Norway to conduct this research in advance of pancreatic cancer clinical trials planned later this year.

“We are very pleased to receive this grant, which will enable us to develop and validate an optimal ultrasound platform for clinical use of ACT. In their respective fields, Humanscan and TGen both represent the cutting edge of science, and we are confident this will contribute to the clinical success of our program,” said Dr Per Sontum, CEO of Phoenix Solutions.

“We are pleased that this research program has become a reality, and look forward to working with ACT. The concept represents a novel approach to targeted drug delivery and looks very promising,” said Dr Haiyong Han, a Professor in TGen’s Molecular Medicine Division and head of the Basic Research Unit in TGen’s Pancreatic Cancer Program.

Among the advantages of ultrasound technology: it is generally painless; non-invasive; does not require needles, injections or incisions; and patients are not exposed to ionising radiation, making the procedure safer than diagnostic techniques such as X-rays and CT scans.

Humanscan CEO Sungmin Rhim said, “We are excited to enter into this collaboration with Phoenix (Solutions) and participate in the development of ACT. Ultrasound-mediated, targeted drug delivery is an emerging therapeutic approach with great potential and we are delighted to be in the forefront of this development.”

The researchers are also is considering this technology for use in addressing other types of cancer, including liver, prostate and triple-negative breast cancer; and other diseases, including those involving inflammation and the central nervous system.


Stroke prevention drugs may help reduce dementia risk for atrial fibrillation patients

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Patients with atrial fibrillation could reduce the risk of dementia by taking stroke prevention medications, according to recommendations published online in EP Europace, a European Society of Cardiology journal, and presented at EHRA 2018.

The international consensus document was also published in HeartRhythm, the official journal of the Heart Rhythm Society (HRS), and Journal of Arrhythmia, the official journal of the Japanese Heart Rhythm Society (JHRS) and the Asia Pacific Heart Rhythm Society (APHRS).

The expert consensus statement on arrhythmias and cognitive function was developed by the EHRA, a branch of the ESC; the HRS; the APHRS; and the Latin American Heart Rhythm Society (LAHRS).

Heart rhythm disorders (arrhythmias), as well as some procedures undertaken to treat them, can increase the risk of cognitive decline and dementia. The international consensus document was written for doctors specialising in arrhythmias and aims to raise awareness of the risks of cognitive impairment and dementia and how to reduce them.

The document states that atrial fibrillation is associated with a higher risk for cognitive impairment and dementia, even in the absence of apparent stroke. This may be because atrial fibrillation is linked with a more than two-fold risk of silent strokes. The accumulation of silent strokes and the associated brain injuries over time may contribute to cognitive impairment.

Stroke prevention with oral anticoagulant drugs is the main priority in the management of patients with atrial fibrillation. The consensus document says that oral anticoagulation may reduce the risk of dementia.

Adopting a healthy lifestyle may also reduce the risk of cognitive decline in patients with atrial fibrillation. This includes not smoking and preventing or controlling hypertension, obesity, diabetes, and sleep apnoea.

“Patients with atrial fibrillation may be able to reduce their risk of cognitive impairment and dementia by taking their oral anticoagulation medication and having a healthy lifestyle,” said Dr Nikolaos Dagres, lead author and consultant, Department of Electrophysiology, Heart Centre Leipzig, Germany.

The document also reviews the association between other arrhythmias and cognitive dysfunction, including post-cardiac arrest, in patients with cardiac implantable devices such as implantable cardioverter defibrillators (ICDs) and pacemakers, and ablation procedures.

Treatment of atrial fibrillation with catheter ablation can itself lead to silent strokes and cognitive impairment. To reduce the risk, physicians should follow recommendations for performing ablation and for the management of patients before and after the procedure.

The consensus document notes that physicians may suspect cognitive impairment if a patient’s appearance or behaviour changes — for example, if appointments are missed. Family members should be asked for collateral information. If suspicions are confirmed, the consensus document recommends tools to conduct an objective assessment of cognitive function.

The paper highlights gaps in knowledge and areas for further research. These include, for instance, how to identify atrial fibrillation patients at increased risk of cognitive impairment and dementia, the effect of rhythm control on cognitive function, and the impact of cardiac resynchronisation therapy (CRT) on cognitive function.


Amazing wireless cancer detection device gets extended US approval

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Endomag celebrate more FDA clearance.

A Cambridge company’s novel wireless device to help locate cancer tumours has been approved for wider use.

Endomag has received approval from the US food and drug administration (FDA) to extend the indication of its Magseed magnetic marker to include both the marking of soft tissue and long-term implantation.

The Magseed marker has already been used to locate thousands of breast cancer lesions, and this FDA clearance makes it the world’s only wire-free localisation device that can be implanted into any soft tissue with no restrictions on the length of time that the marker can remain in the body.

Magseed is a tiny magnetic seed, smaller than a grain of rice, that can be detected using the Sentimag probe. In order to support its extended indication, the Magseed marker was evaluated in a number of soft-tissue models including lymph nodes, lung and thyroid tissue. The Magseed marker is at least 60 per cent smaller than competing non-radioactive localisation devices and is made from low-nickel stainless steel. It’s safe to be imaged under ultrasound, X-ray and can be safely scanned with MRI under indicated conditions. It is also impossible to break or damage during deployment, implantation or surgery.

Eric Mayes, CEO at Endomag, said: “Our team’s ability to innovate for the benefit of clinicians and their patients continues to strengthen, and it’s great to be able to deliver another ‘world first’ with this extended indication for Magseed.”


Carrying the torch for scientific glassblowing

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Walk into a chemistry lab anywhere in the world and you are bound to find an array of glassware being used for all manner of experiments.

Glass has many properties that make it useful for scientific applications, such as good chemical resistance and being transparent and good for heat transfer.

But, despite the important role glass plays in science, the skill to develop the glassware is in decline. Scientific glassblowing has now been classed as an endangered craft by The Radcliffe Trust.

Becoming a skilled glassblower can take as long as a decade according to Radleys Workshop Foreman Paul Robson.

He has been glassblowing for 40 years but his interest in the profession goes even further back. He said: “It was a demonstration with the scouts that kind of stuck with me. Later I attended a course at Braintree Technical College.”

Talking about the craft, Paul said: “It has been in decline because things have changed. The demand for glassware has declined because of alternative materials being available and new chemistry techniques being used.”

“Training has changed, too, and there are no more courses at colleges. You have to go to a local company and learn on the job.”

To help tackle the issue, Radleys has just started its own training programme. Radleys foundations lie in glassblowing and it is still an important part of their business.

Craig Joyce is the first apprentice to join the training programme at Radleys, which takes about 3–5 years. He fell into the job by chance when he was looking for a change after years spent mostly working in customer services at bars and restaurants.

The position caught his eye when he was job hunting. He said: “It looked really interesting. I’ve always liked making things and I like doing DIY at home. I originally worked as a workshop assistant for 6 months before I was offered the apprenticeship.”

Now he is several months into the apprenticeship and is enjoying using his new skill. He said: “I think it’s amazing what you can do with glass and I really can’t speak highly enough of my mentor. I enjoy coming to work every day.”

Craig’s scientific glassblowing apprenticeship combines following a detailed training programme with actually manufacturing items and components for sale. He routinely makes test tubes and adaptors and is building the skill through training to make more complex equipment like jacketed coil condensers.

“It can be very frustrating if you don’t do something right. You can burn yourself, or the item you’re working on can easily crack, or break. You have to be patient, have your eye on the ball and pay attention to minute details.”

But he is spurred on by the thought that the glassware he produces helps scientists all over the world do critical work.

“I like to think what I’m doing makes a difference,” he said.

As well as working on orders from their glassware catalogue, Radleys also deals with bespoke requests from scientists who need a specific piece of glass to help them solve a problem. Paul said: “The bespoke requests are very technical, you have to be determined because it can take a long time to finish what you are making.”

Being dexterous and having the ability to concentrate are just some of the qualities scientific glassblowers need. “You have to be a certain sort of person; perseverance and concentration are important,” Paul said.

You also need to get your head around more technical aspects such as engineering tolerances. Scientific glassblowing doesn’t leave much room for error. If you are not precise, you could end up producing a piece of equipment that isn’t fit for purpose, or is unsafe to use.

Trainees start of by mastering basic techniques, such as joining two pieces of glass, which in itself can take a while. A lot of the process involves benchwork, which’s done by hand with a flame. This gives them a hands on feel for how glass reacts. For example, when it’s molten hot, it follows gravity.

They then learn how to put all that they’ve learnt together. Everything they make needs to go into an oven to be annealed at 570 °C.

They use the raw material Borosilicate, also known as lab glass, or Pyrex glass to laypeople. The glass is usually imported from Germany because they are world leaders in producing it.

A lot of Radleys glasswork involves making reaction vessels for pharmaceutical or polymer companies. Paul’s work as Workshop Foreman also includes dealing with health and safety, technical issues and quality assurance. He leads a team of eight glassblowers.

During his time as a foreman, he has noticed it has become difficult to find trainees. “There is so much scope for other things. Manual skills aren’t at the forefront of young people’s minds.”

But even with the rise of automation, the human touch is still needed for glassblowing. Paul said: “You can use machines for holding hot stuff but you still need a person to do the job.”

Paul estimates there are fewer than 300 glassblowers in the UK. The British Society of Scientific Glassblowers is one of the places the small community can turn to for support.

“They help if we are stuck and they have a good library of resources, including videos,” Paul said. At the society’s latest symposium, Radleys won best in show.

If you think you’ve got what it takes to become a scientific glassblower, and are interested in starting your career with us, then please get in touch. Radleys are always on the lookout for talented people to join our expanding business, from trainees to expert glassblowers.


Tandem’s insulin pump can predict and prevent hypo’s

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New predictive software integrated into an insulin pump can reduce time spent in hypoglycaemia compared with sensor-augmented pumps in type 1 disease.

Medical device firm Tandem Diabetes Care has produced results from its PROLOGtrial, which it will submit to the FDA, potentially paving the way for the product’s launch this summer.

Manufacturers of insulin pumps are competing to produce ‘intelligent’ pumps that can monitor and automatically respond to levels of insulin in patients’ blood streams.

Tandem is competing with rivals such as Medtronic, which has produced a hybrid closed-loop system that adjusts basal insulin delivery based on blood glucose measurements, although users still input mealtime doses and calibrate the system.

Tandem is hoping that the experimental predictive low glucose suspend (PLGS) feature on its t:slim X2 insulin pump will give it the edge.

The company has been updating features on its pump over the years, allowing patients to improve and tweak their device using software updates.

The PLGS  system works by suspending insulin delivery when low blood glucose is predicted, and automatically resuming it when glucose levels begin to rise.

Trial data announced at the Annual Conference on Advanced Technologies and Treatment for Diabetes (ATTD) in Vienna showed the system achieved the primary outcome of reducing time sent in hypoglycaemia compared to sensor-augmented pump therapy alone.

Use of the system during a 3-week period at home reduced the number of sensor glucose readings below 70 mg/dL by 31% compared to the control period using a standard CGM-integrated t:slim X2 Pump without automated insulin suspension.

This marked reduction of time spent in low glucose was accomplished without any increase in the rate of hyperglycemia.

The PROLOG study was a multi-centre, randomised crossover clinical trial comparing two three-week periods of at-home insulin pump use, one period using the t:slim X2 Pump with PLGS, and another period using a standard CGM-integrated t:slim X2 Pump without automated insulin suspension.

The study included 103 participants with type 1 diabetes age 6 to 72 at four research centres across the United States and was co-ordinated by the Jaeb Center for Health Research in Tampa, Florida.

The mean A1C of participants entering the study was 7.3%, with the majority already using a pump (83%) and/or CGM (84%). The primary endpoint of the study was to demonstrate a reduction in the percentage of CGM values below 70 mg/dL when using Tandem’s PLGS feature.

Hypoglycaemia is a huge problem for people being treated for their diabetes and has been linked to increased risk of cardiovascular problems.

The problem is made worse because patients in this state do not realise that they are having a hypoglycaemic episode as their judgement becomes impaired.

Kim Blickenstaff, president and CEO of Tandem Diabetes Care, said: “Reducing the risk of hypoglycemia has been the most requested feature of automated insulin delivery in our market research, due to the severity of the complications when left untreated. The data from this study supports our mission to improve the lives of people with diabetes through new innovations, such as the t:slim X2 Pump with Basal-IQ technology.”