Aktuelle Forschung in Kuren für Typ-1-Diabetes

Sound track for this blog is "Living After Midnight" by Judas Priest, but performed by The Donnas: Research into the Artificial Pancreas (AP) continues to move forward.  The term "artificial pancreas" refers to using a continuous glucose monitor (CGM) to feed data to a computer, which controls an insulin pump, and in some models, a glucagon pump as well.  Artificial pancreas refers to using existing technology in all these areas, but connecting them together so that a person does not need to worry about counting carbs or blood glucose levels.  It is all done automatically. Beginnt mit dem Verkauf Metronic einen "Schritt 2" Artificial Pancreas in Australien The JDRF uses a 6 step model to get to the fully featured artificial pancreas that we wall want.  You can read about that model here:   Right now, Medtronic makes the only commercially available "step 1" artificial pancreas.  However, just recently they started publicising a "step 2" artificial pancreas in Australia.  The difference is that "step 1" APs cut off insulin if you are already too low, while "step 2" cuts you off before you get too low.    This is an important improvement in functionality, but it is also an important regulatory hurdle. The model number is 640G.  I can't find any press releases, or any notice on their web site, but karri on CWD posted this link to a promotional video: There are also several "Ambassador Reviews" on the Medtronic Diabetes ANZ youtube site. It looks like they are taking orders for the device now.  However, I can't see anything on the web site related to the 640G.  Maybe they know I'm from the USA, and can't get it? Of course, the next issue for us Americans is FDA approval.  Medtronic's "step 1" device took 31 months after European approval, before the FDA approved it!  It will be interesting to see if the FDA repeats that fiasco or not.  There has been a lot of progress, several meetings between the FDA and patient advocates (such as DOC, diaTribe, JDRF, etc.) and now we will see if any of that matters. But the clock is ticking now, and we will know a lot more when we see how long the FDA delay of approval is. Eine direkte Einfach Hormone vs. Dual-Hormon-Vergleich In the past, I've tried to compare Single Hormone AP results to Dual Hormone AP results, by comparing similar results from different studies.  However, it's much better to compare the same result in the same study, rathern than combining data from different studies.  A group of researchers at Institut de Recherches Cliniques de Montreal, Montreal, QC, Canada (and elsewhere) recently did exactly this comparison.  They directly compared a regular pump plus CGM, to an insulin only AP, to a insulin and glucagon AP.  Patients (12 years or older) were treated for 3 24 hour periods.  The trial was not blinded. Funding was from the Canadian Diabetes Association, JDRF, and Medtronic (see above for involvement). They reported the following data: Messen Sie Pump CGM Insulin AP Dual-Hormon AP verbrachte Zeit in den Zielbereich von 51% 62% 63% Hypoglykämien 52 13 9 symptomatische Hypoglykämien 12 5 0 Nocturnal Hypoglykämien 13 0 0 Meinungen I think the clear result of this trial is that the dual hormone AP is very slightly better than the Insulin AP, and they are both noticeably better than the current standard pump and CGM.  This result is similar to previous studies. Abstract:  Clinical Trial Registry:  Viele Artikel in der Januar Journal of Diabetes Science and Technology The Journal of Diabetes Science and Technology had a special issue on glucagon therapy.  There were a couple of articles on stable glucagon, which is required for a bihormonal artificial pancreas (such as Dr. Damiano is working on): From this abstract  :

Die Daten werden präsentiert, die auf langfristige physikalische und chemische Stabilität (~ 2 Jahre) 5 ° C, Kurzzeitstabilität (bis zu 1 Monat) unter beschleunigten 37 ° C Prüfbedingungen, Pumpen Kompatibilität für bis zu 9 Tage, und ausreichend demonstrieren Glucose Reaktionen bei Hunden und diabetischer swine. Diese stabilen Glucagon Formulierungen zeigen Nutzen und versprechen für die weitere Entwicklung in der künstlichen Bauchspeicheldrüse Systemen.

From this abstract :

Die Daten werden vorgestellt, die zeigen, physikalische und chemische Stabilität unter vermuteten Lagerbedingungen ([über] 2 Jahre bei Raumtemperatur) als auch "in Gebrauch" Stabilität und Kompatibilität in einer OmniPod® Infusionspumpe des Insulet. Auch Ergebnisse einer Hautreizung Studie in einem Kaninchenmodell und Pharmakokinetik / Pharmakodynamik Daten nach Pumpen Verabreichung von Glucagon in einem diabetischen Schweinemodell dargestellt werden.

Here is a diagram of their results.  Note that they are comparing their glucagon to standard glucagon, so their trial is successful if the same colored lines are close to each other, and they are: Although both of these are animal trials, for this kind of test, I think results in animals are likely to mirror results in people.  They are really measuring the stability of the glucagon, and the test subject species doesn't have a big impact on that.  So my normal worries about "works in mice, fails in people" are pretty small for this kind of research. Hinzufügen Körperliche Aktivität Messungen zu Aritifical Pancreas Berechnungen Also in The Journal of Diabetes Science and Technology, there is this paper: (People in the San Francisco bay area will notice that the authors are mostly local: Drs. Stenerson, two Paynes, Ly, Wilson, and Buckingham.) This paper attempted to use data on physical activity to improve an artificial pancreas's BG numbers. The idea is simple enough: we all know that physical activity lowers BG numbers.  If an artificial pancreas knew how active you were, could it do a better job of controlling BG numbers?   The kids in the study (average age 13), did a soccer workout ("football workout", in the rest of the world) on two separate occasions.  In one case, data from an accelerometer was used to help calculate real time insulin dosing, and in the other case, this data was not used.  BG and hypoglycemic events were measured both during the soccer, but also after it, until the next morning.  There were 18 kids in the study. Overall BG numbers were similar in each group.  Hypoglycemia events were higher when not using the accelerometer, but the difference between groups was not statistically significant. (This is the scientific way of saying "close, but not quite".) Diskussion From my point of view, there are a couple of ways to interpret this result:

Man könnte sagen, dass die Studie war einfach zu früh und zu klein, um die Ergebnisse zu interpretieren, und es ist wirklich eher ein Proof of Concept, wie Beschleunigungsmesser könnte in Zukunft getestet werden. Das, was gesagt werden kann, ist, dass mehr Forschung durchgeführt werden sollte. Oder könnte man sagen, dass Daten des Beschleunigungsmessers nicht für eine künstliche Bauchspeicheldrüse benötigt wird, weil es hier keine statistisch signifikante Wirkung hatte. Und das ist eine gute Sache, denn es bedeutet, dass wir nicht mit Beschleunigungsmessern zu belasten Typ-1-Diabetiker haben (zusätzlich zu pumpen (n) und ein CGM), weil die zusätzlichen Informationen, die sie nicht benötigt wird. Oder könnte man sagen, dass die bestehenden Algorithmen und Beschleunigungsmesser sind nicht gut genug, und wir müssen bessere entwickeln, um Vorteile dieser Informationen zu nehmen. Oder könnte eine Art Spaltung der Unterschied, und sagen, dass die meisten Menschen nicht brauchen, Daten des Beschleunigungsmessers (wie auch durch die guten BG Zahlen berichtet von anderen AP-Tests unterstützt, die sie nicht verwenden). Doch für ernsthafte Athleten, die diese brauchenzusätzliche Daten, brauchen wir bessere Algorithmen (oder Beschleunigungsmesser) zu entwickeln, wenn wir gehen, um diese Daten erfolgreich nutzen. Oder können wir diese Forschung sehen, wie die Frage zu beantworten, "wie viel körperliche Anstrengung erforderlich ist, bevor ein AP Anstrengung Daten muss gut zu arbeiten?" Die Idee ist, dass, natürlich zu einem gewissen Grad von anstrengenden Übungen, Beschleunigungs-Daten benötigt werden. Diese Studie zeigt nur, dass die Fußball-Übungen war nicht genug, und wir brauchen etwas noch kräftig zu tun, bis es keine Rolle spielt.

Interview mit Dexcom Here is a two part interview with the CEO of Dexcom, a big CGM maker.  He talks about future development, both in terms of CGMs for APs and CGMs as a replacement for finger sticks.  I found part 2 more interesting than part 1, but here are links to both: Eine weitere Zusammenfassung Here is another writer's summary of artificial pancreas progress for 2014. Homebrew Artificial Pancreas As Dave Berry used to say: I'm not making this up! This project is being called "Hacking an Artificial Pancreas" or "DIY Artificial Pancreas", but in the tradition of Silicon Valley, I would called it "Homebrew Artificial Pancreas".  It looks like we have reached the point where people can cobble together a functional AP in their garage. You can see pictures here (two quite different paths): If you speak twitter: #DIYPS #WeAreNotWaiting #dexdrip