Sunday, December 4, 2022

Medtronic Closed Loop Insulin Pump

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What Is The Artificial Pancreas

Inside the Medtronic hybrid closed loop insulin pump system and SmartGuard Auto Mode with Rob Howe

In people without diabetes, pancreatic islet cells detect glucose in the blood, and release insulin or glycogen to keep the glucose level in a safe range.

All people with type 1 diabetes use a treatment loop to mimic this function the best we can at present this involves:

  • a pump or insulin pen
  • a blood glucose monitor and maybe CGM , and
  • our brains and fingers to calculate the dose required and deliver it to complete the loop

Closing the loop means making it happen automatically. This means a calculator or algorithm is needed to replace our brains and fingers.

In a hybrid closed loop or artificial pancreas system, the algorithm adjusts the basal insulin every few minutes as necessary, to keep the glucose within a target range. At mealtimes, the user counts their carbohydrate and keys it in to the algorithm, which then decides how much insulin is required and sends an instruction to a pump to deliver the dose.

Watch our two and a half minute video on how the artificial pancreas can help you or your child reduce the impact of daily type 1 diabetes management.

This technology has progressed in the last 10 years:

What Was The Study

The newly published FLAIR study was conducted over six months across seven diabetes centers . The study enrolled 113 adolescents and young adults with type 1 diabetes. The study sample is notable, because teens and young adults with type 1 diabetes have the highest average A1C levels of any age group.

At the beginning of the study, participants performed their usual diabetes management routine for two weeks to establish their baseline glucose levels. Half of the group was then randomly assigned to use the MiniMed 670G system, while the other half of the group used the same pump and CGM, but with the new AHCL algorithm. After three months the halfway point of the study the two groups crossed over, switching to the opposite technology.

A Watershed Moment Transforming Diabetes Care

The JDRF issued a news release on Wednesday, expressing excitement about this landmark technology and how quickly the FDA moved. The American Diabetes Association also chimed in with a news release on this approval, noting its significance.

Think about it: Ten years ago, many still thought a closed loop system of any kind was a pipedream. But JDRF laid out a real blueprint on moving toward an Artificial Pancreas. That was still the very early days of CGM technology and look how far weve come!

This moved incredibly fast, and it shows how important all the hard work was that we did on the policy side back in the day, to create guidance for these systems, said Kowalski, who personally played an important role in making AP tech development a priority. That changed everything and created a pathway, and now were here. Its massive, truly a watershed moment that has the potential to transform diabetes care!

Whether you consider the Minimed 670G an Artificial Pancreas or not is almost beside the point The fact is we have a device now thats closing the loop in ways we havent seen before, constituting an early AP generation. Its potentially life-changing technology thats been made available in record time.

The journey is pretty amazing indeed, as captured in this post by D-Mom and longtime JDRF advocate Moira McCarthy Stanford on how the organization paved the way to this milestone and beyond.

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Insulet Omnipod 5 Aid

Insulet became the 2nd company to receive FDAs ACE designation in September 2019, for its Omnipod Dash system. Dash meets the FDAs cybersecurity, reliable communication, design, and transparency requirements. This ensures it can reliably and securely communicate with other Bluetooth-enabled devices, as well as AID software, and that it can receive, execute, and confirm commands from these devices.

Insulets new Omnipod 5 AID has been submitted to the FDA. It will communicate with Dexcoms G6 iCGM or the new G7 iCGM, and eventually with the Freestyle Libre 3 CGM that is seeking iCGM status. Insulet is working on two hybrid closed-loop algorithms, its own internal Horizon MPC algorithm and, a partnership with Tidepool, on Loops DIY algorithm that may be close to FDA approval. We expect both to have smartphone app controls.

A Loop DIY version for Omnipod Eros pods is already available.

Improved Glycemic Outcomes With Medtronic Minimed Advanced Hybrid Closed

The FDA Approves Medtronics MiniMed 670G Hybrid Closed ...

Diabetes Care

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  • Olivia J. Collyns, Renee A. Meier, Zara L. Betts, Denis S.H. Chan, Chris Frampton, Carla M. Frewen, Niranjala M. Hewapathirana, Shirley D. Jones, Anirban Roy, Benyamin Grosman, Natalie Kurtz, John Shin, Robert A. Vigersky, Benjamin J. Wheeler, Martin I. de Bock Improved Glycemic Outcomes With Medtronic MiniMed Advanced Hybrid Closed-Loop Delivery: Results From a Randomized Crossover Trial Comparing Automated Insulin Delivery With Predictive Low Glucose Suspend in People With Type 1 Diabetes. Diabetes Care 1 April 2021 44 : 969975.

    To study the MiniMed Advanced Hybrid Closed-Loop system, which includes an algorithm with individualized basal target set points, automated correction bolus function, and improved Auto Mode stability.

    This dual-center, randomized, open-label, two-sequence crossover study in automated-insulin-deliverynaive participants with type 1 diabetes compared AHCL to sensor-augmented pump therapy with predictive low glucose management . Each study phase was 4 weeks, preceded by a 2- to 4-week run-in and separated by a 2-week washout.

    AHCL with automated correction bolus demonstrated significant improvement in glucose control compared with SAP + PLGM. A lower algorithm SG set point during AHCL resulted in greater TIR, with no increase in hypoglycemia.

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    You Still Cant Fall Asleep At The Wheel

    HCL systems cant do everything. They cant predict the stock market. They cant figure out the teenage brain. And they cant offset rapid changes in blood sugar levels. HCL systems make relatively subtle insulin adjustments in a reactive manner, using insulin that takes hours to either clear or take effect. Think of your diabetes as a huge ship with a small rudder moving at a very fast speed. Even if you turn the rudder as far as it can go, it is going to take a while for the ship to change course. The pumps basal adjustment just isnt powerful or responsive enough to prevent high and low glucose levels when confronted with anything that causes blood sugars to rise or fall quickly, such as:

    Physical activity

    Stress

    Sudden hormone changes

    Active bolus insulin

    In other words, timely/accurate bolusing on the part of the user is still necessary, as is adjustment for day-today lifestyle events such as exercise and stress. Although most HCL systems have temporary overrides to make the algorithm more or less aggressive than usual, their effects are modest and gradual, and the overrides usually need to be set well in advance.

    What Is The Biggest Difference Between Looping And Not

    Ive been looping for a little over a year now, and Ive noticed the biggest difference in my overnight blood sugars.

    Since this is a hybrid closed-loop system , the system performs best when there are fewer variables.

    Ive noticed that I require a lot more basal insulin overnight to help combat the dawn phenomenon, which I used to struggle with, but dont worry about anymore.

    Looping has also helped me improve my time-in-range and greatly has decreased the number of hypoglycemic events I have per week while achieving my lowest hba1c ever, 5.9%.

    Exercise and eating are easier with the loop, too. I can set exercise mode on the app an hour before I begin an exercise, and I rarely go low.

    When I am eating a meal, if my carbohydrate count is slightly off, the loop will increase my basal to make up for it, without sacrificing good blood sugar.

    A typical 12-hour graph on my Dexcom continuous glucose monitor app. It is much easier to stay in range with an automated system.

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    Pay Attention To Bolus Timing

    Bolusing late will cause the HCL system to ramp up your basal insulin, and may produce hypos a few hours after the bolus is finally given. And since extended bolusing is not an option with most HCL systems, it will be necessary to alter the timing of boluses for slowly digesting meals. This can be accomplished by entering the carbs in two parts or letting the system know that your meal will take many hours to fully digest . A sound understanding of the glycemic index can be helpful.

    Systems Available In The Uk:

    Introducing the MiniMed 670G Hybrid Closed Loop System
    • CamAPS FXhybrid closed loop uses a DANA insulin pump and Dexcom CGM. . Licenced for those aged 1+
    • Medtronic 670G + Guardian sensorshybrid closed loop uses Medtronic insulin pump and sensors. This system adjusts the basal rate to minimise predicted highs or and low glucose. Licenced for those aged 7+
    • Medtronic 780G + Guardian sensorshybrid closed loop uses Medtronic insulin pump and sensors, and minimises high and low glucose by adjusting the basal rate and delivering correction boluses. Licenced for those aged 7+
    • Control IQhybrid closed loop uses Tandem t:slim insulin pump and Dexcom CGM. Licenced for those aged 4+

    Earlier generations / systems that are less automated:

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    Features That Can Help Make Managing Diabetes Easier

    • SMARTGUARD AUTO MODE

      Pump automatically adjusts background insulin every 5 minutes to help you stay in target range.*

      Helps prevent highs and lows

    • MINIMED MOBILE APP

      See insulin delivery and sugar trends on your smartphone. Plus, receive high and low glucose alerts.

      Discreetly check your numbers

    • ENABLED FOR FUTURE SOFTWARE UPGRADES

      Enabled for future software upgrades, when such software upgrades are available. Customers will be offered a software upgrade at no charge through October 27, 2022.

    • CARELINK CONNECT APP

      Friends and family can view your sugar trends and insulin data on a smartphone.

      More peace of mind for care partners

    • EXERCISE SETTING

      Temporarily changes the glucose target to give you less insulin during activity.

      May help reduce lows during activities

    • Your pump and CGM data can now be automatically shared with your healthcare provider.*

      Enables convenient virtual appointments

    Does Arkansas Diabetes And Endocrinology Center Do Any Research For Closed

    Yes, Arkansas Diabetes and Endocrinology Center is the leading center for closed-loop insulin pumps in the state of Arkansas and one of the top providers of this technology in the country. We have recently conducted a clinical research trial of an Advanced Hybrid Closed Loop System . Qualified patients are able to receive the groundbreaking change in technology that began with the FDA approval of the first artificial pancreas, Medtronic 670G, and now 770G at our center. Our leading team of specialists were involved in the research trials that brought this technology to the market, making this therapy a reality. The specialists at Arkansas Diabetes and Endocrinology Center were the first in the state to use the artificial pancreas system.

    We also are managing patients on the new Tandem T-Slim and Dexcom Closed-Loop Technology with no finger sticks, and are constantly providing patients with more options as technology continues to evolve.

    Throughout the United States, Dr. Thrasher is currently educating other healthcare professionals on the use of this system. Dr. Thrasher also sits on the Data Monitoring Board which oversees all of the Medtronics Closed Loop Clinical Trials.

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    So Thankful For This Life

    In the end, looping has only made my life with diabetes easier. I get to live a more carefree existence, one where I dont have to micromanage my care 24 hours a day, 7 days a week.

    When Im hiking with my husband in the mountains of Colorado or on vacation at the beach, I trust that my blood sugar is quietly humming along in the background, and I worry about going low and high less often.

    It feels great to know that the technology I trust is making dosing decisions based on the amount of insulin I already have on board, what my correction factors are, and what time of day it is, and it creates more space in my brain for other, non-diabetes related things, like life, work, family, and fun.

    I am anxious for an FDA-approved tubeless hybrid closed-loop insulin system , but until then, Im a bonafide looper.

    Cgm Insulin Pump Players Look To 2021 As Watershed Year For Diabetes Wearables Market

    This is closed loop: Introducing Medtronics MiniMed 670G ...

    Insulet, Dexcom and Medtronic have product launches planned this year, looking to capitalize on the recent skyrocketing of virtual care due to the coronavirus pandemic.

    The coronavirus pandemic has spurred an explosion in telehealth and digital health as patients stayed out of hospitals and doctors’ offices to slow the spread of the virus turned to virtual care.

    As a result, the healthcare landscape has significantly changed over the last 10-11 months and companies are making moves to capitalize on the rise of tech-driven services and wearable devices.

    Patients embraced devices like continuous glucose monitors and insulin pumps in recent years before the pandemic, and companies in these markets like Dexcom and Insulet or Medtronic and Abbott Laboratories have remained successful despite the economic volatility throughout 2020.

    Now, Wall Street and industry see 2021 as a watershed moment for diabetes technology. Along with plans to expand into new markets, nearly every major player in the CGM and insulin pump space have product launches this year, one of which J.P. Morgan said could be the year’s biggest for industry.

    As the CGM and insulin pump markets gain momentum, companies like Dexcom and Insulet point to a large, under-penetrated patient population as the largest growth opportunity.

    As both patients and providers rely more and more on virtual care, digitally-based diabetes management stands to gain further momentum.

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    What Do Insulin Pumps Cost

    This can be a tricky question, because when it comes to diabetes technology the cost often varies based on ones insurance coverage.

    Generally, you can spend thousands of dollars on the initial purchase because youre buying a new device along with that first set of supplies to use it. The starting cost can be anywhere from $3,000 to $8,000 depending on the device, and monthly supplies can also add up quickly. Most companies do offer payment plans, too.

    Keep in mind, this is just the first-time buy and doesnt include the needed pump supplies including infusion sets, tubing, cartridges or reservoirs for insulin, as well as adhesives wipes for site prep. Of course, youd also need to purchase the insulin to fill the pump and any separate CGM supplies that you might use alongside this pump.

    Even with insurance, it can cost hundreds of dollars per month to afford an insulin pump.

    Most private insurance companies cover insulin pumps under the durable medical equipment portion of the policy. Youll need to work with a doctor to get a prescription and Letter of Medical Necessity confirming your diagnosis and medical need.

    The paperwork can be somewhat daunting, so most insulin pump companies offer help in the form of dedicated insurance service teams that work with patients to apply for coverage.

    The terms of coverage vary, and your choice of covered device may be limited because some insurance companies have preferred deals with certain pump makers.

    Training Needed For Users And Clinicians

    Many pump wearers switch to AIDs using the same or similar settings to those on their insulin pumps. Unfortunately, pump setting errors are rampant, as demonstrated by the poor A1c results and excessive glucose varibility among pump wearers. Setting errors generate erroneous basal and bolus doses and, unless remedied, place those who start on an AID at a serious disadvantage. Training for clinicians and users is lacking.

    Clinicians and users are also often unaware of which settings will even impact their glucose control after starting on an AID. Which setting should they change and by how much when readings remain erratic? Which have no relevance in the algorithm? Additional training and guidance are required for clinicians and users. We encourage you to visit our Pump Dose Guide for setting suggestions before starting on an AID or when attempting to salvage an inauspicious start.

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    Optimize Your Cgm Performance

    Just about everything the HCL algorithm does is based on CGM data. If you use a sensor that requires calibration, do so on schedule using a clean finger and a high-quality meter. Even if your CGM does not require calibration, it is worth spot-checking your sensor performance with periodic finger-sticks and calibrating if necessary. Also, it is best not to use your sensors beyond their intended lifespan, as the accuracy can suffer.

    Minimed 670g System Resources

    The brains behind the MiniMed 780G System Algorithm

    Learn protocol for interpreting CareLink Auto Mode reports.

    1.2MB

    Learn protocol for identifying patients and setting expectations.

    59KB

    Understand protocol for transitioning patients to the MiniMed 670G hybrid closed loop system.

    67KB

    Guide to the basics of diabetes and how the body works, insulin pump therapy, and carbohydrate counting.

    2.4MB

    Learn a simple approach to managing SmartGuard Auto Mode.

    222KB

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    How Can A Closed

    A closed-loop insulin pump system essentially works as an artificial pancreas, providing the body with controlled levels of insulin for an extended period of time. These devices provide peace of mind to diabetes patients, knowing that their blood sugar levels will stay within a normal range a great majority of the time. They also remove the need for daily shots, which provides the patient with convenience and also saves a great deal of time.

    At Arkansas Diabetes and Endocrinology Center, we are able to work with you in achieving your ideal expectations from any of the CGM or insulin pumps. We are proud to be the leader in bringing technology, research and medicine to our state and continue to strive for the highest patient satisfaction.

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