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  • Advice Pool - Patrick the Insulin Pump - Can New Technologies Improve Your Blood Glucose Control?

    For four years we've lived with Philip, our nickname for my daughter Alissa's insulin pump. He's become a part of the family and we'll say a sad goodbye to him when we return him in a few weeks time.

    On Wed
    According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
    nesday we finally picked up Patrick, the replacement for Philip from the diabetes nurse at the hospital.

    Patrick is a Minimed Paradigm pump capable of many cleverer things than his predecessor and should hel
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    Alissa improve her diabetes control and, hence, her health.

    Whilst changing from injections to an insulin pump has enabled Alissa to live far more flexibly and enjoy life as a student over the past few year
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    s, our diabetic nurse suggested that it was time to try out one of the newer designs of insulin pump to experience further benefits from the latest developments.

    Improvements to the Pump

    One key impr
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    vement is the intelligent bolus wizard. Simply input your current blood glucose level, the amount of carbs you've eaten and it will calculate how much insulin you need to bolus, checks you're happy wi
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    h the amount its calculate and then proceed to deliver it.

    Unless you're a maths whizz, this alone will be helpful as you don't need to make those mental calculations in your head!

    You're also able to progr
    ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
    am the pump to react to different levels of insulin sensitivity at different times of the day. Most control regimes don't take this into account, although it's a well documented medical fact. This could be
    easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
    ey factor in helping to improve blood glucose control.

    One of the useful aspects of the bolus wizard on the Paradigm insulin pump is that you can set target levels that you'd like to achieve at various times
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    of the day. An example of the use of this would be that at bedtime you might target a slightly higher blood glucose level than during the day, to minimise the risk of hypos. Even if you're aware of your nee
    and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
    d to run a slightly higher level at nighttime, it's hard to remember this late in the day when you're tired and hungry.

    The instructions on the pump are written in English rather than using images and
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    symbols, so it's much easier to learn to use and understand. For example, when you input a low sugar level to the bolus wizard, it will issue a warming that you need to eat before you bolus, a helpful
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    safety factor.

    Two other improvements are that the new pump takes ordinary AAA batteries - so that in an emergency you'd be able to purchase them from the nearest store.

    Also the new enclosed design
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    means that dust is far less likely to get into the workings of the delivery mechanism.

    Alissa tells me that Patrick is also slightly smaller than Phil - another bonus.

    Getting on with Patrick

    Of cou
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    se, once we picked up Patrick, we still had to order the necessary supplies, since the sets, cartridges and batteries are all a different design.

    Now we're ready to start getting to know how Patrick works an
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    find out just how to get the most out of him.

    This new pump has given us an opportunity to re-work Alissa's basal insulin rates which have remained unchanged for several months (apart from a big boost post-
    t?

    As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
    Christmas). This will mean recording foods, blood glucose levels and fasting from meals - but should be well worth the information that we obtain to help target insulin rates and sugar levels.

    We'll be foll
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    wing the manual carefully as we get used to the new capabilities of the pump, but look forward to a far better level of HBA1C next time we visit the consultant at the hospital. Not only that, but better cont
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    ol of blood glucose should result in Alissa feeling healthier, fitter and full of energy.

    We were unsure of the benefits of changing insulin pumps, having been in our comfort zone for several years. Yet, th
    .

    As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
    e information that we've discovered about the new technolgies available on insulin pumps has made us wish that we'd made this move much sooner.

    The next few weeks will be a time of adjustment and a big learn
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    ng curve, but I'm hoping that our next visit to the hospital consultant will be a positive one where we'll be able to see and measure the improvements to Alissa's health and blood glucose control.

    Can't wait


    tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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