Diabetes Technology Meeting 2006
The sixth annual Diabetes Technology Meeting was held in Atlanta from November 2 - 4, 2006. In attendance were over 500 scientists, engineers, and doctors from government, industry, academia, and clinical practice. During the two-and-a-half days of sessions, speakers shared information on a variety of topics, including continuous glucose monitoring, non-invasive glucose monitoring, the nature of interstitial fluid and lag time versus blood, insulin delivery alternatives, and various types of computer technologies. Here is a summary of some of the sessions:
- During one of the pre-meeting workshops, academic and industry panels examined the physiology of interstitial fluid, an understanding of which is key to the success of today's continuous glucose sensors. Much of the discussion focused on the perceived lag time between capillary blood glucose readings and the corresponding glucose reading from interstitial fluid. Presenters included Gary Steil, Ph.D., from Medtronic MiniMed and Thomas Peyser, Ph.D. from Abbott Diabetes Care, who, with the rest of the esteemed panel, in the end agreed that there is a short physiological lag between blood glucose levels and interstitial glucose levels of about five to nine minutes.
- Bruce Bode, M.D., spoke about Advanced in Hemoglobin A1c Point of Care Technology, during which he discussed the new Metrika A1cNow+ HbA1c device. Dr. Bode began by noting that only 20% of people with diabetes are seen by endocrinologists, and that of the remaining 80%, the average HbA1c is over 8% -- well above any organizations target. To help physicians who do not have access to a device like the Bayer DCA2000+, Dr. Bode reported on the many improvements in the Metrika A1cNow product, resulting in the new A1cNow+, which has a variance of around 3% and a blood volume of 5 microliters -- both significantly better than the previous device. The new A1cNow+ will be available in 2007 and will be available over the counter for home use. Note that Metrika was acquired by Bayer Diabetes care in July 2006.
- Boris Kovatchev, Ph.D., from the University of Virginia, spoke about Glucose Variability, Risk Analysis, and the Temporal Structure of Continuous Monitoring Data. Dr. Kovatchev is widely regarded as one of best (if not the best) scientists working on developing algorithms for closed loop systems. He examined the unique nature of glucose data provided by continuous sensors and explained new and innovative ways of using that data to determine a patient's risk, whether for hypoglycemia or hyperglycemia. At the end of the session about continuous data, the audience was asked what they thought was most predictive of hypoglycemia. 58% chose glucose variability. Dr. Kovatchev noted simply "that is the correct answer," to the delight of everyone.
- Sharbel Noujaim, Ph.D., from LifeScan presented a novel approach to hypoglycemia alarms in Accuracy Requirements for a Hypoglycemia Detector: An Analytical Model to Evaluate the Effects of Bias, Precision, and Rate of Glucose Change. Dr. Noujaim explained the model as the "baseball plate" and, in essence, the model requires three thresholds: a hypoglycemia threshold, an alarm threshold, and a critical threshold. Conceptually, the hypoglycemia threshold is the upper limit of being low, the critical threshold is the level below which you never want to be, and the alarm level is in between. This model has some potential advantages related to fewer false positives than systems which alarm only on crossing one threshold.
- Stuart Weinzimer, M.D., from Yale presented Closed-Loop Artificial Pancreas: Feasibility Studies in Pediatric Patients with Type 1 Diabetes. He reported on his team's work using a Medtronic insulin pump and CGMS system, coupled with a laptop computer to run the control algorithm. His study looked at complete closed-loop operation and a hybrid system in which patients pre-bolused half their required prandial insulin before meals. As might be expected, users of the hybrid system experienced better control, especially reductions in post-prandial peaks -- however, there were a very small number of participants. Of particular importance is the dramatic improvement in control compared with open loop pump use: closed-loop participants spent 81% of the day in range vs. 58%, 15% high versus 33%, and just 3% low versus 8% (p<0.002). This work is very encouraging.
- Edward Damiano, Ph.D., from Boston University presented Closed-Loop Blood-Glucose Control Using Dual Subcutaneous Infusion of Insulin in-vivo as part of the session about using glucagon and insulin as part of an artificial pancreas. He reported on his team's success with a closed loop system using both insulin and glucagon, delivered via two Cozmo insulin pumps, in a pig model of diabetes. His system requires only the weight of the pig to control blood glucose levels. Data presented showed good control even after the pigs ate, well, like pigs -- sometimes consuming 300 grams of carbs in one quick meal. Dr. Damiano's team also showed that commercially available glucagon from Eli Lilly worked fine for up to seven days in the insulin pump. (Another presenter, Kenneth Ward, M.D., also found commercial glucagon to be stable in solution for many days.) Prior to the presentations about using glucagon, just 47% of conference participants thought that glucagon will be required. By the end of the sessions, 60% said glucagon will be required.
- Solomon Steiner, Ph.D., Chairman and CEO of Biodel, Inc., presented ViajectTM, A Very Rapid Acting Novel Formulation of Recombinant Human Insulin. Viaject is basically Humulin Regular insulin with unique additives that change the absorption characteristics such that the Viaject essentially remains monomeric and is absorbed extremely rapidly -- even faster than rapid acting insulin analogs. Absorption times as measured by T-Max basically showed Viaject being absorbed in about half the time of Humalog. In addition, Viaject showed lower variability in action than both Humulin Regular and Humalog. Since insulin kinetics remain a challenge, novel formulations like Viaject have the potential to improve care.
- Stuart Weinzimer, M.D., also presented Variations in Insulin Analog Pharmacodynamics in Pediatric Patients Using Insulin Pumps. In this study, the Yale team looked at the performance of insulin pump infusion sets at one and four days, with both Humalog and Novolog insulins. Basically, they found no difference between insulins and a slight difference in insulin action from one day to four days, though Dr. Weinzimer noted that not every participant was able to wear an infusion to for four days. His major advice from this study was that you should not stack boluses for three hours because of prolonged insulin action.
Joournal of Diabetes Science and Technology.
November 5, 2006
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