At a pediatric diabetes conference I attended some six years ago, there was a presentation on pancreatic cell transplantation by a well regarded researcher. Having myself come from a background in biotechnology, and then as now being convinced of the potential of biotechnology in medicine, I inquired about the prospects for cell transplantation for diabetes. I was struck by the answer, which was that while cell transplantation for diabetes was already clinically successful, the practical solution for diabetes management (particularly for Type 1 or insulin-dependent diabetes) would first come from the "artificial pancreas" approach of an integrated glucose monitor and insulin pump, including a "closed-loop" system. Moreover, this solution would likely be available (FDA approved) for some time before cell transplantation become a practical alternative.
Cell transplantation to provide a cell-mediated solution to the problem of biochemical deficiencies is, after all, not a technologically challenging task from a clinical standpoint, at least superficially. Cells and tissues may be readily transplanted to patients via a variety of means. However, maintaining that an allogeneically transplanted cell population in the recipient through the use of anti-rejection drugs, or producing autologously-derived cells that bypass immunologic rejection, is an expensive proposition, and therein lies the challenge. Fast forward six years and the picture for cell therapy in diabetes has not substantially changed, with routine clinical practice still just beyond the horizon.
The artificial pancreas, by contrast, is very nearly a practical alternative now due to the fact that glucose monitors and insulin pumps are currently easy to manufacture at reasonable costs and have gained regulatory approval as an "open loop", "integrated" system, requiring input from patient or clinician to adjust insulin dosage in response to alerts or routine blood glucose readings. This is the essence of the MiniMed Paradigm® REAL-Time Revel™ System by Medtronic, which recently gained FDA approval. See this synopsis via EuroInvstor.co.uk:
When using Medtronic’s glucose sensors with Paradigm Revel Insulin Pumps, trend alerts can notify patients of rapid changes in glucose levels so that they can take immediate corrective or preventative action after confirming glucose levels with a fingerstick glucose measurement. Several new CGM features, including predictive and rate of change alerts, provide earlier warnings of potential glycemic excursions to help patients stay in their target range. According to recent internal study, the use of predictive alerts improved hypoglycemic event detection by 36% compared to the standard low glucose alert. All alerts can be customized to suit a patient’s lifestyle, such as creating different settings to accommodate for exercise or to manage nocturnal hypoglycemia.
The use of an open loop system like this is a big step forward in the management of diabetes, which has to this point been entirely dependent upon the diligence of diabetics in taking the initiative to manually test their blood glucose multiple times daily and dose themselves via injection or set insulin infusion to correct for glucose highs or match insulin d to carbohydrate intake. Any steps toward automating the process of detecting glucose and matching it to insulin delivery is significant.
The next milestone in the development and regulatory approval of an artificial pancreas will be the closed loop system in which blood glucose measurement will be integrated in a biofeedback system to insulin infusion without the necessary intervention of patient or clinician to set insulin dosage.
The status of diabetes management technologies is the subject of ongoing MedMarket Diligence research.