Diabetes Technology Meeting 2007
The seventh annual Diabetes Technology Meeting was held in San Francisco, California from October 25-27, 2007. In attendance were over 800 scientists, engineers, and doctors from government, industry, academia, and clinical practice. During the three days of workshops and sessions, speakers shared information on a variety of topics, including continuous glucose monitoring, non-invasive glucose monitoring, glycemic variability, insulin delivery alternatives, the state of the artificial pancreas, innovative insulin preparations, and various types of computer technologies. Here is a summary of some of the sessions:
- During the pre-meeting workshop on Glycemic Variability, John Lachin, Sc.D. from George Washington University said that his well-publicized model that supposedly showed a higher risk of retinopathy for people receiving conventional therapy compared with intensive therapy at the same level of HbA1c were wrong, and that a new Cox proportional hazard model, correcting for age, gender, duration of diabetes, and other factors show that all risk can be explained solely by HbA1c.
- Boris Kovatchev, Ph.D., from the University of Virginia, a regular speaker at the Diabetes Technology Society meetings, introduced the Variability-Grid Analysis model, a new way to look at overall diabetes risk -- both short-term hypoglycemia risk and long term hyperglycemia-associated risk. The new model uses maximum and minimum blood glucose values over a period of time (for example, a week) to assess overall diabetes control. As usual, there was considerable discussion afterwards about his idea.
- George Cembrowski, M.D., Ph.D., from the University of Alberta in Edmonton, Canada, spoke about Hemoglobin A1c: Whose Normal Range Is It Anyway? While his presentation was in the context of whether HbA1c should be used as a tool to screen people for diabetes, he presented some interesting data about HbA1c variability by age and among various ethnic groups. Of note is that "normal" HbA1c increases during a person's lifetime, regardless of whether they have diabetes or not, and this should be taken into account in any screening program.
- In a substitute presentation, Dr. Thomas Pieber spoke about research into combining a subcutaneous glucose sensor and insulin delivery catheter to determine if a continuous glucose sensor would work in the presence of local insulin. The results of the study showed that glucose levels could be measured accurately in the presence of insulin, which means that a single cannula glucose sensor and insulin infusion catheter could be developed. This would be of great interest to everyone using both an insulin pump and continuous sensor and could lead to an easier-to-wear artificial pancreas.
- Arleen Pinkos from the FDA spoke about FDA and the Artificial Pancreas, exploring what needs to be done to build an artificial pancreas that will meet the requirements for regulatory approval. She specifically mentioned the need to improve the accuracy of continuous sensing for more of the time and better performance in the hypoglycemic range, the need to address inflammatory and immune response issues at the site of sensor probes, and a need to address issues surrounding the stabilization period of sensors. Of note were her comment that such a device does not have to be perfect and that a replacement claim for a continuous sensor is not required for the FDA to approve a closed loop system. Representatives from industry who were in the audience took detailed notes, as expected.
- W. Kenneth Ward, M.D., from iSense Corporation presented Simultaneous Use of Multiple Glucose Sensing Units, in which he showed the potential benefit of using several sensors and a voting algorithm to improve the overall accuracy of a glucose sensing system. The voting method yielded in significantly better accuracy than a simple averaging method and could be used to address accuracy concerns in a closed loop system.
- The most interesting presentation of the entire conference was Insulin Replacement Gene Therapy for Type 1 Diabetes Mellitus by Anthony Cheung, Ph.D. from enGene, Inc. of Vancouver, Canada. Dr. Cheung spoke about modifying gut K-cells, which are already responsive to glucose levels, to secrete insulin in addition to GIP. Using transgenic mice treated with STZ to destroy beta cells, the enGene process resulted in euglycemia. Furthermore, in tests using the NOD autoimmune model of diabetes, modified K cells were not subject to the underlying autoimmunity of diabetes. Large animal trials in pigs are scheduled for 2008, with human trials currently slated for 2009.
- Andreas Pfützner, M.D., Ph.D., presented Mealtime Glycemic Control Comparing VIAject™ to Lispro. VIAject is a novel insulin preparation that starts with regular human insulin and adds ingredients that prevent the formation of insulin hexamers and yield a molecule that is essentially monomeric. This results in extremely rapid onset of action and significantly shorter duration of action compared with regular insulin and even the rapid-acting insulin analogs. With delay in onset of insulin action an issue in the overall performance of a closed loop system, insulin like VIAject has the potential to help pump users achieve better glycemic control and to allow closed loop systems to be more responsive to rising glucose levels. In addition to its faster kinetics, less VIAject insulin was needed for a given glucose load, and this can help reduce the risk of hypoglycemia.
- Upkar Bhardwaj, M.Pharm, winner of the Peterson Student Award, presented Composites for Long-Term Inflammation Control on s.c. Implantation of Biosensor. Bhardwaj explained a process in which specially engineered microspheres were filled with the anti-inflammatory steroid dexamethasone and bonded to biosensor probes prior to insertion. Using two different microshpere sizes, one of which survived in vivo for about a month and the other which survived for about 90 days, Bhardwaj was able to eliminate the immune system response at the insertion site for an extended period of time. This work hints at the potential for very long lasting subcutaneous glucose sensors.
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October 28, 2007
Last Updated: Tuesday October 30, 2007 18:16:02
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