Friday, June 21, 2024

Artificial Pancreas System For Diabetics

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Does Insurance Cover It

Artificial pancreas for diabetes treatment tops Cleveland Clinic’s 2018 top 10 medical innovations

Most of the time, insurance companies cover pumps and sensors, and I wouldnt expect it to be any different with this system. The device is considered durable medical equipment. Coverage will likely hinge on a doctor writing a letter of medical necessity for it. The insurance company will request documentation of medical necessity, which is pretty standard

Over The Past Three Years Sam Wright Mother To Sofia Has Endured The Tremendously Steep Learning Curve Any Parent Of A Child With Type 1 Diabetes Has To Undergo A Whirlwind Of Finger Prick Tests Injections And Sensors Later She Has Now Discovered The Camaps Fx App And The Hybrid Closed

In a hot summer, excessive thirst wouldnt be anything out of the ordinary for a young child. However, Sam and her mother followed their intuition that Sofias condition could be something more serious and began to research if there was any cause for concern, which ultimately led to her diagnosis of type 1 diabetes.

The diagnosis changed everything forever, says Sam. I can remember the first few weeks like it was yesterday. Almost overnight I felt like I needed to be an expert in diabetes to best care for my little girl. She is my absolute priority, so I just did it, and I feel really proud of myself and my mum for doing it shes been on this journey with us from the beginning.

How The Artificial Pancreas Works

The artificial pancreas, or closed-loop insulin delivery system, continuously monitors blood sugar levels, calculates the amount of insulin required, and automatically delivers insulin through a pump.

The artificial pancreas, or closed-loop system, lets your insulin pump talk to your continuous glucose monitor . Based on your blood sugar levels, and the direction theyre heading, the device will automatically adjust the amount of insulin your pump is delivering.

The technology has the potential to change lives, making living with diabetes easier and helping people have more stable blood sugar levels.

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What Is An Artificial Pancreas And How Does It Differ From Insulin Pumps

The artificial pancreas developed to measure and adjust blood glucose levels as the pancreas does in people without diabetes is a medical device that is worn like an insulin pump. A subcutaneous sensor measures glucose levels, which are transmitted wirelessly into a device with a sophisticated computer algorithm that interprets the data and controls delivery of the correct amount of insulin via an insulin pump .

Figure 1: Schematic illustration of an artificial pancreas.

A glucose sensor measures interstitial glucose levels and transmits information into a control algorithm within a handheld device . The algorithm modulates subcutaneous delivery of a rapid-acting insulin analog via an insulin pump . Communication between the glucose sensor, control algorithm and insulin pump is wireless.

The artificial pancreas system replicates the normal role of the beta cell.

Reproduced from Elleri et al

Bergenstal explains that during the development of the artificial pancreas, weve been adding technology piece by piece, each one having an incremental benefit, and that combining these technological advances will meet two goals of better glycemic control and reduced burden for patients.

Benefits For Pregnant Women With Type 1 Diabetes

Artificial Pancreas for Diabetics Seeks FDA Approval

A few years later we backed another world-first trial. Professor Helen Murphy investigated how the artificial pancreas could help women with type 1 diabetes during pregnancy, where managing the condition is even more challenging.

In 2016, Professor Murphys trial showed the device was safe and improved blood sugar control in 16 expectant mums who took part, and, most importantly, led to healthy births and babies.

Laura Carver was one of the women who took part when she was pregnant with Sonny .

I felt like I no longer had diabetes because of the artificial pancreas. It was managing my condition and worry away.

“I knew I was giving myself the best chance of a healthy pregnancy. I genuinely believe that without the study we may not have the family that we have today.”

Laura Carver, who took part in a life-changing research trial

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Modular Architecture For Sequential Ap Development

Todays technological advancements open the possibility for ambulatory AP. To account for the multitude of available possibilities, academic, and industrial developments, we have introduced the concept of modular approach to AP design, which allows technologies developed by different entities to be seamlessly integrated in a functional hierarchical system that can be sequentially deployed in clinical and ambulatory studies. presents an outline of this modular-architecture concept.

Artificial Pancreas To Revolutionise Diabetes Care In England

Nearly 900 patients with type 1 diabetes in England are testing a potentially life-changing artificial pancreas.

It can eliminate the need for finger prick tests and prevent life-threatening hypoglycaemic attacks, where blood sugar levels fall too low.

The technology uses a sensor under the skin.

It continually monitors the levels, and a pump automatically adjusts the amount of insulin required.

Six-year-old Charlotte, from Lancashire, is one of more than 200 children using the hybrid closed loop system.

Her mother, Ange Abbott, told us it has made a massive impact on the whole family.

“Prior to having the loop, everything was manual,” she said. “At night we’d have to set the alarm every two hours to do finger pricks and corrections of insulin in order to deal with the ups and downs of Charlotte’s blood sugars.”

About 400,000 people in the UK have type 1 diabetes, a condition where the body can’t produce insulin, the hormone which regulates blood sugar levels.

NHS England says it is the first nationwide test of the technology in the world, and it comes 100 years after the first diabetes patient received insulin injections.

The hybrid system is not completely automated, because the amount of carbohydrates being eaten at mealtimes needs to be inputted.

Charlotte’s consultant Dr May Ng, a paediatric endocrinologist at Ormskirk District General Hospital, thinks the new technology has huge potential.

Yasmin told us she finds the new technology liberating.

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Are There Likely To Be Any Barriers To Clinical Implementation

From the physician perspective, some rethinking, some retraining and some new implementation skills are required before the artificial pancreas can be used in the clinic, believes Bergenstal. He also says that new terminology, such as closed-loop systems and changing the insulin active time will require incorporation into training for healthcare providers.

Bergenstal notes that patients must be committed to working with the artificial pancreas, with a mindset of I can envision myself wearing technology. He emphasizes that healthcare providers must communicate to patients that if they put in the time to work with the artificial pancreas, what is really difficult to start with gets easier and easier.

Other possible barriers to the use of artificial pancreas systems include the need for recalibrations, periodic replacement of sensors, physician time, lack of software standardization, the need for clinical practice guidelines, cost, and in the USA variable reimbursement .

A recent study also identified physical barriers to wearing glucose monitors and insulin pumps, including discomfort and appearance, which could be targeted to increase device use.

Can I Get An Artificial Pancreas

Admetsys on its artificial pancreas for treating diabetes | Capital Connection

The system is still being tested for safety and effectiveness and, as of 2016, home and clinical trials of the system have been completed in participants with both type 1 diabetes and type 2 diabetes.

Research is being conducted worldwide and each teams expertise to their respective products is helping to speed up the process of devices coming to market.

The next step for the researchers is to test the technology on a larger number of people.

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Diabetes And The Artificial Pancreas: Closed

An article I read recently declared that the artificial pancreas, or a closed-loop artificial pancreas system for diabetes management, is likely to hit the market by 2018. This is potentially life-altering news for anyone with Type 1 diabetes this is the next step in diabetes care that we have been waiting for. But what is a closed-loop artificial pancreas system, and what are the details researchers need to iron out for such a system to truly be a viable day-to-day option for diabetes management?

A closed-loop artificial pancreas system is a device, or series of devices, that can work in concert with one another to automatically give the correct amount of insulin in response to food intake and rising blood glucose. There is also research into dual-hormone systems these would provide insulin in response to rising blood sugars, and provide glucagon in response to falling blood sugars. However, the current formulations of glucagon are not as stable as would be ideal, and the reservoir would have to be replaced every 24 hours. The most likely candidate for release in the near future is a closed-loop artificial pancreas system that only supplies insulin. Such a system would be much less likely to CAUSE hypoglycemia, but on the occasions when hypoglycemia does occur, it would simply alert the user of low blood sugar and still require us to eat some of our good old glucose tablets.

A New Day Of Celebration

Researchers will soon undertake one of the largest-ever long-term clinical trials of a system designed to help regulate blood sugar levels of individuals with type 1 diabetes mellitus. If the scientists so-called artificial pancreas system performs in patients as they hope, it could lead to commercial trials and eventual regulatory approval in the United States and abroad.

With $12.7 million in support from the National Institutes of Health , the system developed by a team of researchers from the University of Virginia School of Medicine and the Harvard John A. Paulson School of Engineering and Applied Sciences will be tested in 240 patients at nine sites in the United States and Europe. The two six-month trials will begin early this year, in collaboration with other institutional partners.

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Threshold Suspend And Predictive Suspend Systems

The threshold suspend and predictive suspend systems can temporarily stop or suspend delivering insulin if your blood glucose level gets low.1

The threshold suspend system stops delivering insulin when your blood glucose level drops to a pre-set level. The predictive suspend system calculates your blood glucose level and will stop delivering insulin before your blood glucose level gets too low. Neither system automatically increases insulin doses.

Stopping insulin delivery at the right moment can help a person with type 1 diabetes avoid low blood sugar, or hypoglycemia, a condition when a persons blood glucose level is lower than their target range. These systems may help people with type 1 diabetes who develop hypoglycemia overnight, particularly children.

Insulin Pumps Systems Available Only Outside Of The Us

MiniMed 670G artificial pancreas

4.4.1. Cellnovo Insulin Pumps

The Cellnovo system is an insulin pump available to patients in Europe, but not currently available in the US. The system is comprised of a small insulin pump that is controlled via Bluetooth technology with a locked down Android device. The pump has short tubing and uses an adhesive to attach to the skin. It is water resistant to a depth of 36 feet for up to 1 h. This system also includes an activity tracker and food library, as well as applications for data management .

4.4.2. Kaleido Insulin Pumps

The Kaleido insulin pump is newly available in Europe at this point. Some of this pumps unique features include the option of placing the infusion site with variable lengths of tubing to accommodate for different locations on the body and the insulin pump can be placed on the skin with an adhesive or placed in a pocket. Also, the system comes with two rechargeable pumps that can be used interchangeably and a handset that controls insulin delivery via Bluetooth technology. The pumps are water resistant up to a depth of 3.3 feet for up to 1 h however, the pump charging station and handset must be kept dry. Kaleido also offers 10 color options for the insulin pump .

4.4.3. Roche Diagnostics Accu-Chek Insulin Pumps

4.4.4. Sooil Dana Diabecare Insulin Pumps

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Is Any Surgery Required To Use The Device

No, patients can insert the sensor themselves with a spring-loaded device. You pop in the needle and pull it out. The thin sensor filament stays in place. The data transmitter, a little radio shaped like a clamshell and a little bigger than a thumbnail, sticks out. To shower or swim with it, you can tape it down.

The sensor should be changed about once a week.

Trialing The Groundbreaking Organ

The National Institute of Diabetes and Digestive and Kidney Diseases are supporting this vital research to the tune of $12.6 million.

The artificial pancreas has begun its final trials in nine locations across the US and Europe. For the first phase, 240 patients with type 1 diabetes will trial the system for 6 months. The second run of trials will see 180 patients from the first phase wearing the system for a further 6 months.

Designed in conjunction with TypeZero Technologies in Charlottesville, VA, the system will be compared with a standard insulin pump against two major criteria: how well blood sugar levels are managed and whether the risk of hypoglycemia or low blood sugar is reduced.

Kovatchev explains his aims for the artificial pancreas:

To be ultimately successful as an optimal treatment for diabetes, the artificial pancreas needs to prove its safety and efficacy in long-term pivotal trials in the patients natural environment.

Our foremost goal is to establish a new diabetes treatment paradigm: the artificial pancreas is not a single-function device it is an adaptable, wearable network surrounding the patient in a digital treatment ecosystem.

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The Tandem insulin pump, no bigger than a mobile phone, infuses insulin under the skin at the command of Control-IQ software, which has received blood-glucose data from a Dexcom G6 sensor.

In some ways, this is a family story. Peter Kovatchev was a naval engineer who raised his son, Boris, as a problem solver, and who built model ships with his granddaughter, Anna. He also suffered from a form of diabetes in which the pancreas cannot make enough insulin. To control the concentration of glucose in his blood, he had to inject insulin several times a day, using a syringe that he kept in a small metal box in our family’s refrigerator. But although he tried to administer the right amount of insulin at the right times, his blood-glucose control was quite poor. He passed away from diabetes-related complications in 2002.

Boris now conducts research on bioengineered substitutes for the pancreas Anna is a writer and a designer.

It was yet another confirmation of Arthur Clarke’s First Law: “When a distinguished but elderly scientist states that something is possible, he is almost certainly right. When he states that something is impossible, he is very probably wrong.”

However, in people with type 1 or insulin-requiring type 2 diabetesof whom there are nearly 8.5 million in the United States alonethe pancreas produces either no insulin or too little, and the control process must be approximated by artificial means.

Tandem Diabetes Care


Is There An Advantage To Bihormonal Over Single Hormone Systems

Closed-loop Artificial Pancreas for Diabetes Patients

In nondiabetic people, the effect of insulin is counteracted by glucagon, whereas glucagon secretion is impaired in those with type 1 diabetes. Therefore, the use of both hormones in an artificial pancreas is a logical and feasible option for managing hypoglycemia .

A small study comparing closed-loop control with insulin plus glucagon versus insulin plus placebo found that high gain pulses of glucagon decreased the frequency of hypoglycemia relative to placebo . More recently, Edward Damiano and colleagues showed that a bihormonal artificial pancreas significantly improved glycemic control compared with an insulin pump among adults and adolescents .

In a randomized crossover trial published in late 2016 , researchers demonstrated that a bihormonal artificial pancreas that can be used at home and is initialized only with body mass index provides improved glycemic control compared with usual care among 39 adults with type 1 diabetes.

The study authors explain that since meal announcements are optional and carbohydrate counting is not required, using the bihormonal artificial pancreas could reduce the patient burden associated with management of diabetes.

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What Is An Automated Insulin Delivery System

Although it sounds like a single appliance that you would just plug into your body, the fact is, we are not there yet.

Its taken researchers decades to connect various diabetes devices using a combination of cables and wireless technology and creating a system that can mimic what a healthy pancreas does monitor glucose levels and deliver insulin as needed.

Currently, an AID system is essentially an insulin pump connected to a continuous glucose monitor . The monitor is controlled via a receiver using sophisticated software algorithms to make the whole thing work.

The idea is to automate blood glucose control as much as possible, so the wearer no longer has to take fingerstick blood sugar readings and then calculate how much insulin to dose or reduce based on readings. Some systems can even shut off insulin delivery automatically based on low blood sugar readings detected by the CGM. And some systems are experimenting with carrying glucagon in the pump alongside insulin to bring blood sugar up when necessary.

These systems are at various points in development, from clinical studies to early commercial products to those hacked by tech-savvy DIYers who dont want to wait for FDA-approved products. Incredible strides are being made, and new groups and companies seem to be emerging to work on this exciting advancement in diabetes technology.

Components included in current AID systems:

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