A Look at the Artificial Pancreas Project

Constant glucose monitors have brought us one step closer to developing an artifical pancreas

Every once in a while it’s a good thing to stand back, take a look at where you have been and gather your strength to go forward. So today we are going to review what is happening with the Juvenile Diabetes Foundations Artificial Pancreas Project.

Started in 2005 as a research project, it has become a high stakes partnership between industry and science to develop a runner-up to a cure. The Artificial Pancreas Project aims to develop a machine that combines the insulin delivery accuracy of an insulin pump with the blood glucose detection capabilities of a continuous monitoring device in a closed loop system that has a rudimentary brain.

In this type of setup the two devices talk to each other and, using mathematical algorithms, determine how much insulin to automatically deliver into your system.

Presto! You, the middle man, are taken out of the equation (which is the way most of us would like it). After all, in people without diabetes all of those minute calculations take place behind the scenes and happen quite well without mindful input. Having a closed loop system would help those with type 1 (or type 2 patients with end stage beta cell destruction) lower the ever-present, everyday diabetes stress.

Hospital-based trials using these devices have shown them to be effective in controlling blood glucose levels and reducing overnight hypoglycemia in people with type 1.

In June of 2011, the ties that bind efficacy and efficiency came together in a study that showed that Medicare would actually save over 1.9 billion over 25 years as a result of the reductions in diabetes complications stemming from the device’s projected ability to improve glucose control.

Next, the Project participants need to figure out how well the device works in out-patient and real-use situations. The Food and Drug Administration (FDA) gave the project a shot in the arm with its December 2011 guidance paper on accelerating the development and availability of artificial pancreas technology.

The paper is a first step in clearing the way for fast track development. And just this March, JDRF has responded to the FDA document with suggestions of its own—they want the FDA to take a broader view in its definition of allowable clinical trials and to formally recognize “Time in Range” (for blood glucose) as a primary study endpoint.

The FDA’s positive response to the technology has spurred expansion in the medical device market. Companies such as Abbott, Medtronic, Dexcom and Roche are competing to bring higher end sensors and delivery devices to market.

Here's a graph of the results from Dr. Wolpert's study

And Joslin has already started to make use of this technology in research on insulin dosing—a team headed by Howard Wolpert, M.D., studied the amount of insulin needed to cover meals high in fat versus low in fat, with the closed loop as the system to maintain glucose control.

The next two years should be exciting as more refined sensor technology becomes available for everyday use—bringing us a step closer to a life altering technologies

Further information on the artificial pancreas project can be found at www.jdrf.org.

This entry was posted in Diabetes Day2Day and tagged , , . Bookmark the permalink.

21 Responses to A Look at the Artificial Pancreas Project

  1. cheryl hart says:

    I have been a diabetic since I was 10 years old and I now wear an Insulin Pump which I love… I would be interested in all of the information on your new product.
    Thank you
    Cheryl

  2. I’m just not understanding why this is such a big deal. We still live in a world where most people can’t even get basic diabetic supplies (glucometers, test strips etc) and only a few can afford or get coverage for existing diabetic high tech (insulin pumps, CGMS).

    I expect the closed loop artificial pancreas will cost even more than current insulin delivery systems and be even less likely to be covered by insurance. I have excellent healthcare insurance through my employer. A small co-pay covers all my diabetic supplies. Some would say I’m lucky.

    But I’m also a fastidious patient. I test, I carb count, I’m very well controlled. My A1C fluctuates between 5.5 and 6.3. Sounds great. Except because my diabetes is so well controlled the insurance company won’t pay for an insulin pump or CGMS. Quality if life is not a factor in the equation for an insurance company. What matters is health outcome and I don’t see how this piece of high tech improves outcomes better than current tech.

    • Tammy Crawford says:

      The answer to that lies in graph shown above that talks about “time in range.”
      Studies show that even with a great A1C our time in the range of a normal blood sugar is much lower than with a CGM or artificial pancreas. Since the A1C is an average of your blood sugars over a period of time some are high and some are low and your numbers can still average to a good A1C. With these newer devices you stay in the correct range much more consistently thus reducing your chances for complications even further. Congratulations on the great job you are doing!

    • Barbara says:

      Well stated.

      Healthcare FINANCE policy in the USA is owned and run by Wall Street Insurance Corporations and those with T1D live or die by their heartless decisions. You are quite right that ACCESS to this technology in the USA is a matter of privilege and wealth. I would love to see Joslin (with all its claims to fame and glory) go after this issue, as well as the JDRF which is essentially silent on the matter of ACCESS and equity.

      Who benefits? Who loses? This is the most important question.

      • Donna From Dexter says:

        I agree JDRF does not work for the individual nor with insurance companies. I found that being outspoken for care is the only way to get what I need. Why do wired pumps cost $7.500+ and the Omnipod (wireless) cost only $1,500?

  3. Donna From Dexter says:

    I agree that insurance companies will not pay for this. My co-pay for all of my supplies is 50%. I requested an Omnipod insulin pump – my first pump – after 55 years of being a diabetic – and of course it was denied. I eventually received it….in 8 months I will be on Medicare and they also do not pay for any cordless pumps. Doesn’t everyone in the world use a cordless product i.e. cell phone? Why is Medicare refusing to pay for a cordless pump? This month I hit my 60th year as a diabetic. It has been a struggle even after 60 years. Nothing easy about this disease.

    • Leon Ullrich says:

      After being a Type 1 diabetic now for over 66 years, I have benefited by some wonderful advances in diabetic research & in supplying equipment in helping to achieve better control and thus a longer lifespan. For what has been done, I am very grateful for these advances as they have helped me to have a better quality of life than I would have had without them. For me the big advances have been the blood glucose meter & the insulin pump.

      The current environment still provides a difficulty in dealing with the cost of these advances for many T1 diabetics. Now with the artificial pancreas in the foreground as well as the current GCM technology, how many more T1 diabetics are going to be unable to have these benefits because of lack of funds and/or insurance coverage? As a “Senior” diabetic, Medicare will not cover any expense of the CGM much less an Artificial Pancreas, and of course the secondary insurance will not cover anything not covered by Medicare.

      My Question – Is there any organization, persons, or political figures trying to help look after the Quality of Life for the Senior Type 1 diabetics and trying to get coverage for the new advances on the horizon to help make them available as well as affordable?

      • Donna From Dexter says:

        Last year I sent President Obama, Senator Levin, Senator Stabenow and one letter directly to Medicare. The only one to respond was Levin. Quote “If a bill passes through the legistrative process I will approve the bill.” Not much of a yes, but at least I heard back. The President I will excuse as it was around the same weekend that Bin Laden was eliminated. Lobbist from JDSU, Joslin, Bill Gates is what is needed. However, until the disease hits home is the problem important. T1 has never been supported…..T2 is the new disease of the 21st century.

      • Barbara says:

        I am directly and deeply involved in policy research regarding the Financing of health care and my horizon includes all citizens, not only those with T1. However, what I do see nearly everywhere is a profound lack of understanding on the part of those who pass legislation, as well as in the medical community itself. I, too, have watched T1 “control” going from the most primitive techniques to the highly sophisticated options on the market today. Wherever I research in the Policy space, I come away more anxious than before. The evidence about better control with advanced technologies is Everywhere (and better control saves costs as well as lives), and yet it is denied to all but those with the private wealth to pay. All the while MDs and hospitals complain about the “burden” of chronic illnesses. However, here are just some of the players involved in PREVENTING this from occuring: (i.e., preventing real reform and access)

        -AMA
        -AHA
        -AHIP (specifically Karen Ignani)
        -PHarma
        -IOM (Institute of Medicine – the IOM is a wimp on this whole issue.The IOM is behind the public support of the notorious EHB (Essential Health Benefits) required by individual states and it is simply a giant loophole for unenlightend state officials to nix anything they want.

        -American Cancer Society
        -JDRF
        -Healthcare Manufacturing sector (stents, pumps, pacemakers, you name it)
        -Investment banking industry ***
        -NIH (National Institutes of Health again, in contrast to their talk)
        -Academia (yes, indeed)
        -ANA (American Nurses Association either out of ignorance or politics, or both)

  4. Philip Bellone says:

    I wrote an Excel program that gives me my morning and evening blood, and carb/calorie averages chart. I can look at my blood average, look at what I plan to eat and calculate how much fast and slow acting insulin I need to take to keep my A1c to under 6.8…too much insulin makes the body absorb more calories than you need and subsequently gain weight which requires more insulin.

  5. Bill MacCracken says:

    Part of the key to getting a pump is having the right doctor. When I first got a pump my doctor asked if I was interested and pushed it through, writing all the justifications to get the insurance to pay.
    My current doctor would not go to that trouble and last time I got a refresh I switched plans to one that was more willing to buy pumps. It is a bit of a game and takes a bit of work to formulate a strategy.

  6. Joan Stephens says:

    I found you have to have durable medical equipment covered on your insurance policy at 100per cent to get strips, glucometer and pump supplies covered. One pan I had covered insulin but the present plan only covers insulin under prescription coverage at 50 per cent . I am having to pay almost 900 per month for my health insurance and it will increase next month. I have had diabetes 52 years. Iam too young for Medicare still have a few more years Is there any help for all these expenses we are incurring.

    • Donna From Dexter says:

      Medicare will not supply/pay for insulin unless you are on a pump. All other diabetic supplies i.e. test strips they cover. Why does diabetic supplies fall under durable medical equipment? Once used it cannot be used again like a walker. If you all rememeber it wasn’t until 1998 that the US Govt mandated that diabetic supplies needed to be paid by private insurance companies. I still don’t understand why wireless pumps are still not covered by Medicare.

      • Denise says:

        I have had T1 diabetes for 34 years and use both Lantus, and Humalog insulin pens. I have Medicare (age 49 and disabled due to other medical issues) and they cover the pre-filled pens. As pre-filled pens contain insulin I know it is covered in that form, but my cost (portion not covered by Medicare) is over $200 per month. I was on a pump for 5 years while I was still able to work and had good insurance coverage, but had to give it up and go to pens because of the cost once I was on Medicare.

  7. Ann Marie Montello says:

    I am thrilled about all the research going on with the artificial pancreas model. I have been diabetic for 47 years, and on an insulin pump for 29 years. I was one of the first diabetics in the nation to go on the first pump, which was quite large and did not work too well to say the least. Then more sophisticated pumps emerged and life was better, even with the tubing attached to my pump and myself. Now I am on an insulin pump that is wirless, my insurance paid for it in full, by Insulet Corp. right here in Massachusetts. I love the Omni Pod set up but it is not the answer. I am still in need of a pump that monitors my sugar and reacts to it!! I test ten times a day and still have highs and lows at times. Insurance companies need to get on with it and pay for everyone’s infusion systems. It does save them bucks in the long run. I would volunteer in a second to be in the artificial pancreas study. Good luck to all of the companies doing this research!

  8. Harold Persails says:

    How can one Volunteer to test this system out?

  9. Florian says:

    I think Pump Manufacturers should take a bigger role in helping pumpers setup all the numbers on their pump so they can get the maximum and most efficient use out of the pump. I believe a recent questionnaire for pumpers indicated that quite a few did not believe their pumps were setup properly.
    I’m talking about basal rates, I:C ratios, insulin sensitiviy factor, and duration of activity.

  10. Katie says:

    I am doing great with healthy diet, exercise, frequent blood testing and insulin pump, but this sounds so exciting! I can’t wait to be one of the first ones to try this out!

  11. Joe says:

    I use a Dexcom 7+ CGM and Animas pump. I have huge flucations in my BG and vary variable A1c. I find my dexcom varies 10-25% from my Test and sometimes the diffeence is so great that I feel like a reaction, test to find I am at 51 and the DexCom reads 220, then sometimes the DexCom reads below 70 and I am at 130. How does the algorythm deal with the variability? Usually the Dexcom and BS are within 15% but not always and Carbs to bolus ratio for the same food on different days results in different BS readings after 2 1/2 hours. I would love to be able to have a reliable closed loop system, but I am a little worried about how it handles flucuating, stress, weight and other factors besides food, exercise and insulin that impacts BS.

    On the insurance coverage issue, my insurance just recently started rationing how many test strips, infusion sets and pump cartridges based on an expert review board, now I get 3 test strips per day, 1 infusion set per every two cartridges used in my pump and insulin based on 60 units per day, the rest is 100% out of my pocket. It was explained to me that they had introcuced the expert review to combat fraud as required by the mandate to spend 85% of premiums on care to avoid Federal penalties. I am not sure if this is true, but it does seem regardless of the doctors prescription some items have become harder to get covered in the past year. Despite an item being covered, there are ,imits that previously were not imposed.

    • Barbara says:

      Reply to Joe re: Variability

      Joe is quite correct and he presents a common and very difficult scenario and dilemma faced by many. The enclosed content is an answer I provided to a Health Care Professional when this person questioned us about a daily routine with T1D:

      Decision Factors When Managing Insulin Dosages on a Daily/Hourly Basis

      (These are the facts and/or questions asked every time my loved one and I make a decision about how much insulin he/she is getting, or should be getting, in response to blood glucose level (BG) at the time)

      BG = Blood Glucose
      Basal = Baseline for homeostasis

      1. Time of day
      2. Current activity level
      3. Past activity level(s)
      4. Near future activity level
      5. Prior BG levels (24-48 hours)
      6. Insulin type if using Lantus vs Pump
      7. Age of insulin (i.e., vial in use for 30 days or more)
      8. Most current basal dosage recommendations delivered via pump
      9. Most recent outcomes of dosage adjustments to basal, bolus, correction factors, I:Carb ratio
      10. Site of injections/pump infusion set
      11. Ketones (pos/neg)
      12. Growth spurt (Y/N)

      13. Food intake by TYPE:
      a. Carb
      i. How many grams carb per serving?
      ii. Quick acting
      iii. Slow acting
      iv. Glycemic index of carb
      v. Fiber content of carb (subtract from grams of carb)

      b. Protein intake (type and amount)

      c. Fat intake and composition (amount of fat in food combo)

      14. Food intake TIME OF DAY
      15. Food intake AMOUNTS (relative proportions)

      16. Overall health
      17. Age/hormones
      18. Stress levels (either physiological or psychological)
      19. Personal input to the decision process (this is important !! )
      20. Logistics (i.e., will I be able to get to my loved one in the event of an unpredictable response to changes in insulin dosage)
      21. Overall BG goals – both daily and average
      22. The individual’s level of understanding (both the person w/T1D AND healthcare professional’s)
      23. Current weight in lbs and kg
      24. Change in body weight (Y/N)
      25. “GUT” feel and wise intuition

      Will a new state-of-the-are artificial pancreas do all the above? Does it even matter if new rules prevent anyone from getting even the low-tech BASICS for optimal care? Joe’s information about “expert review to combat fraud as required by the mandate to spend 85% of premiums on care to avoid Federal penalties,” is a ruse by large highly profitable insurance corporations to hit the most vulnerable. It is an outrage, plain and simple.

Leave a Reply

Your email address will not be published. Required fields are marked *

*


*

You may use these HTML tags and attributes: <a href="" title=""> <abbr title=""> <acronym title=""> <b> <blockquote cite=""> <cite> <code> <del datetime=""> <em> <i> <q cite=""> <strike> <strong>