We follow several innovations with interest.  A list of intriguing ideas we are watching are outlined below.

Treatment

  • Smart Insulin.

    Insulin is an $18 billion annual market for major drug companies and is the largest segment of the T1D medical equipment and supplies market.  The holy grail for insulin therapy is the development of so-called “smart insulin” which when injected will remain inactive until blood glucose levels begin to rise above normal levels.  At this point it will become active and reduce BG levels until they reduce to normal.  Merck acquired a small company that had created a smart insulin.  We believe that major drug companies have a tremendous incentive to develop such an insulin because of the existing market opportunity.
  • Faster Acting Insulin.

    There is a delay between the time of injection and the time insulin acts on the user’s blood glucose level.  This uptake delay varies by individual and can be  as quick as 30 minutes or as long as 90 minutes in most people.  In order for bolus insulin to be most effective faster acting insulin would prevent blood glucose levels from rising during the “uptake delay” inherent in users.  Once again we believe that major drug companies have a tremendous imbedded incentive to create this insulin because of their existing sales and the existing market opportunity.  A true single hormone AP will not be effective until these faster acting insulins are perfected.
  • Improve the accuracy of CGM’s.

    With the exception of one device, CGM’s on the market today have an error rate of between 15% and 25%.  The Dexcom G4 has error rates of 12% which puts it on par with HBGM.  We believe the size of the existing market provides an incentive for existing suppliers to improve their devices.  A true AP device will not be optimal until CGM accuracy improves.  One company (Sensionics) has an implantable CGM in clinical trials in the U.S.
  • Intelligent HBGM.

    Existing meters provide only a display of the blood glucose reading.  Many users find it difficult to interpret the trend of their blood glucose readings and have limited ability to discern anything from the pattern of their blood glucose readings.  We believe an HBGM with embedded software to “interpret” the blood glucose readings and provide actionable recommendations to the user would be a tremendous improvement of the existing “dumb” HBGM’s.
  • Artificial Pancreas.

    The concept of an artificial pancreas is to use sophisticated software algorithms to interpret the blood glucose readings from a CGM to make automatic adjustments to the user’s insulin therapy.  There are several such devices in clinical trials in the U.S.  Substantially all of these devices are single hormone (insulin) and rely on insulin shut off to raise blood glucose levels.  Because of the delays in insulin uptake and the IOB phenomenon, we believe that an insulin only pump may not be the most effective solution.  Another device, the Bionic Pancreas, is also in clinical trials.  This device uses both insulin (to lower blood glucose) and glucagon (to raise blood glucose).
  • Continuous Intraperitoneal Infusion.

    Another solution for the insulin uptake delay is the possibility of surgically attaching a catheter to near the user’s intraperitoneal (near the liver).  A port on the skin would provide the user with access.  An insulin infusion pump could be attached to the port. The delivery of insulin directly to the portal vein would virtually eliminate the uptake delay (and would similarly eliminate the “insulin on board” phenomenon because insulin would be immediately action and would clear the body quickly – thus turning off the flow of insulin would cause blood glucose levels to rise much faster than any existing treatment).  Roche’s Diaport device is in clinical trials in the U.S. and Europe. A Diaport-like device would enable single hormone AP systems to control blood glucose more effectively.
  • Implantable Pump.

    Medtronic developed an implantable infusion pump more than ten years ago.  Some of these devices are still used in Europe to treat “brittle diabetics” who cannot otherwise effectively treat their blood glucose.  Like the CII, an implantable pump would have limited insulin uptake delay and would virtually eliminate the insulin on board phenomenon.   The challenge with such a device is the cost (at least $100,000 for the surgery and related treatment).  These devices also use a faster acting insulin which is not yet approved in the U.S.
  • Improve ease of use and communication.

    Infusion pumps are currently used by only 20% of T1D patients.  Among the reasons for the limited adoption are the difficulties the user faces interacting with these devices.  A simpler and more intuitive iPhone like user interface would likely improve adoption by both patients and physicians.  Another challenge for pump, CGM and HBGM users is that a very small minority of users “upload” the data from these devices to their physicians.  Once again we believe this is because of poor user interface.  A simpler user interface (or perhaps automatic uploading over the web) would help resolve this issue.  A related issue is that the user’s data cannot be automatically (or manually) transmitted to care givers (parents, for example). HIPPA and other regulatory impediments make this simple exchange of information challenging.
  • Practical Cure

  • Beta Cell Replacement.

    In the U.S. there are only enough cadaver pancreas to supply islet cells for 1,500 islet cell transplants.  As a result, we believe one of the greatest needs for creating a Practical Cure is to develop a larger supply of islet cells or beta cells to treat the millions of T1D patients.
  • Stem Cell Derived Islet Cells or Beta Cells.

    There are a number of alternatives to this approach.  The first, immune-pluripotent stem cells or iPS, are provide by the patient.  In the lab researchers cause these stem cells to differentiate into beta cells which can then be reintroduced into the user.  A second approach is to use embryonic stem cells for the same purpose.  Researchers have been successfully differentiating stems cells into “precursor” beta cells (cells that when injected become beta cells), but have not yet perfected the process to generate functional beta cells in vitro.  We have supported research at HSCI and DRI for beta cell creation work.
  • Beta Cell Implantation.

    Merely implanting islet cells into the patient results in limited recovery because the patient’s immune system attacks and kills the newly introduced cells (and therefore the treatment must be effected with aggressive immune suppressant drugs which have a number of serious side effects).  In order for islet or beta cell implantation to work, the new cells must be protected from the body’s autoimmune response.  Encapsulating the cells is one approach, but merely encapsulating the cells is typically not sufficient.  An implantation vehicle (a basket) with a protective coating of nutrients and perhaps a topical, short acting immune suppressant may also be necessary.  We have supported work at DRI for the beta cell implantation vehicle they call the Bio-Hub. Other groups such as Viacyte and J&J Betalogics’ are also working on innovative ways to not only produce glucose-responsive, insulin synthesizing beta cells, but also on how to effectively make them inconspicuous to the autoreactive T cells.
  • Immune Therapies.

    The ability to stop the T1D patient’s immune system from attacking his own beta cells is critical to any long term solution. Researchers are working on a variety of ways to re-educate the T1D’s immune system.  Columbia University is working on a mixed chimerism approach for building immune tolerance by transplanting both bone marrow alongside islet cells. This state will trains the patient’s immune system to accept the newly transplanted cells and, as a result, reversing the autoimmune attack. The most promising part of this strategy is the lack of immunosuppressants needed to maintain islet transplant acceptance post-transplantation. The DRI as well as other groups are exploring similar techniques that vary in the chemical/radiation regimen used to induce acceptance of the transplant, called conditioning.  This experimental treatment still has a few years to go before clinical trials and  is  currently being studied in animal models.
  • Immunoablation.

    This treatment is used in many aggressive forms of cancer.  In the most aggressive approach, for treating juvenile diabetes, (the Brazil protocol) the patient undergoes chemotherapy, which wipes out his immune system, then the lab reintroduces new immune system components (typically bone marrow).   The hospital stay is long, not to mention that recovering from the chemotherapy and rebuilding the immune system can take as much as two years.  The procedure is expensive and involves a higher degree of risk than many patients will be willing to accept.  Other techniques use less aggressive means to knock down the autoimmune response in an attempt to be more targeted.
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