Monthly Archives: June 2013

Wordless Wednesday… That’s more like it.

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In Monday’s post I complained a lot about how crazy my glucosity was all weekend. But now it seems like things have calmed down a bit. The photo above is from last night, and it reflects how my BG has been behaving for the past two days. Granted, my high and low markers are pretty high and pretty low, but at least I’m doing better over the last 48 hours or so.

And check out this graph from last night… A little low around 11:00 (treated with juice), then steady during sleep. Mind you, I haven’t really done much different except staying hyper-aware of how I’m trending:
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#MakesSenseIfYouHaveDiabetes
 
 
 

On the glucagon trail.

We spend a lot of time around here talking about diabetes and keeping our blood glucose levels from getting too high. But we haven’t spent any time, really, talking about the treatment for seriously low blood glucose levels. I’m talking about glucagon.

Today, glucagon as an emergency medication carries the same set of instructions that it has for a long time: A nine step set of procedures (according to Eli Lilly & Co.) that involves using a syringe to inject an inactive ingredient into glucagon, mixing it, and drawing it back into the syringe and injecting it into the hypoglycemic patient.

I guess that sounds a little antiquated, plus a little time-consuming at a time when every second counts. But what can be done about that? Is there anyone out there working on streamlining glucagon delivery?

I met a couple of people back in March who are with a company that is working hard on new ways to make glucagon simpler and easier for anyone who may need it to treat hypoglycemia. Austin, Texas based Xeris Pharmaceuticals is on the front lines in a niche part of the market, working on a couple of projects and getting funding from the National Institutes of Health.

One of those projects is something called the Glucagon Pen (or G-Pen™). Also, they’ve received additional funding recently via a Phase II installment of a Small Business Innovation Research (SBIR) Fast Track grant to advance the company’s room-temperature stable, non-aqueous glucagon formulation for the advancement of a bi-hormonal pump artificial pancreas. You heard that right. Bi-hormonal. Insulin and Glucagon. The total of the grant funding amounts to $1.05 million.

Today I’ll be sharing a brief interview with a company representative, and information on some of their competitors.

I had a chance to ask a few questions of Saretta Ramdial, Manager of Corporate Affairs at Xeris. I had a few more questions besides these, but they are on hold for now. Some things can’t be revealed while research continues.

Stephen: I met part of your company’s team back in March at the Capitol-area JDRF conference. Are you going to a lot of these? Are they all patient-related functions, or are there conferences, etc. featuring healthcare professionals that you’re also going to?

Saretta Ramdial: We attend a number of different types of conferences that range from scientific and technology-focused to patient-advocacy focused events. This year, we’ve participated in the JDRF Type 1 Now conference in Austin, TX (our second year in attendance) and the JDRF Research Summit in Bethesda, MD (where we met you!). We plan to attend the ADA’s Scientific Sessions Conference as well (we had both of our abstracts accepted this year). We also attended the Taking Control of Your Diabetes conference in December 2012 which was held in Austin, TX.

Stephen: Tell me about how Xeris is revolutionizing the idea of glucagon delivery. I understand this includes glucagon that doesn’t require mixing, and can be delivered via a pen?

Saretta Ramdial: Our lead product in development is the Glucagon Pen or G-Pen™ which utilizes our proprietary, room-temperature stable, liquid formulation of glucagon, a rescue drug for hypoglycemia. The current standard of care is a nine-step process which can seem arduous in an emergency rescue situation where the caregiver must assemble and administer an intramuscular injection. From the patient perspective, Xeris’ solution would be more straightforward than and just as effective as the current glucagon kit because of its patient-friendly approach and ease-of-use. The G-Pen™, similar to an EpiPen™, would be a pre-loaded ready-to-use auto-injector device that would cut the administration of glucagon down from nine steps to two (uncapping and pressing the pen against the skin).

The G-Pen™ technology will be applied to a mini-dose glucagon pen (G-Pen Mini™) which can be used for smaller zero-calorie dosing applications for mild to moderate hypoglycemia. This is especially important for people with weight management concerns when it comes to managing the sometimes unpredictable rollercoaster of blood sugar levels.

Stephen: Are you receiving any funding from sources like JDRF, ADA, or other diabetes organizations?

Saretta Ramdial: We receive funding from a number of sources including the National Institutes of Health (NIH), The Helmsley Charitable Trust, and The Emerging Technology Fund through the State of Texas Governor’s Office.

Stephen: Do you have any competition in this space right now? (I’ll be looking this up anyway, but I thought I would ask).

I actually didn’t get an answer to the question, but I was provided with the link to a Closer Look memorandum, from Kelly Close’s Close Concerns. It’s available via the Xeris website:
http://xerispharma.com/2012_06_08_CC_Xeris_Glucagon.pdf

The memo is a detailed five page research sheet that goes into great detail about who is working on glucagon solutions (no pun intented). According to the memo (dated June 8, 2012– used with permission), the Xeris glucagon pen is being designed to be stored at room temperature, with a two year shelf life. So… a G-Pen™ with simple steps, that doesn’t need to be refrigerated. And, the work with organizations that are going to clinical trials very soon with an insulin/glucagon bi-hormonal pump for the Artificial Pancreas.

I looked online for information about the competitors working in this space that were mentioned in the memo. I couldn’t find much online, so the following is partly from the memo and partly from what I found online.

The Competitors:

Arecor: The biggest development I’ve been able to find lately is their collaboration with Eli Lilly to develop the same type of glucagon formulation that Xeris is working on.

Biodel: Again, working on a stable glucagon that will be viable for two years at room temperature. Last September, Biodel was awarded a National Institutes of Health (NIH) grant to develop glucagon for a bi-hormonal AP pump. Last December, the FDA granted orphan drug designation to Biodel’s product. The FDA grants orphan drug designation to help promote development of therapies to treat rare diseases (don’t know how rare diabetes is these days). They may also be eligible for FDA grant funding, certain tax credits, and a seven year grant of exclusivity to their drug should it gain FDA approval. Just last Thursday, Biodel announced plans to apply to the FDA for an Investigational New Drug Application sometime in the next twelve months. If that’s OK’d, they’ll go into clinical trials by the second half of next year, with an eye toward applying for an official New Drug Application with FDA sometime in 2015. In addition to the glucagon, this application should include the injection device too.

Enject: Speaking of injection devices, Enject has a nice demonstration of their pen on their website. And, that’s about all I could find. The Closer Look memo talked about a delivery system that would reduce the steps needed to inject glucagon down to just three, and mentioned that they anticipate filing a New Drug Application with the FDA by the end of this year.

Latitude: In April of 2012, Latitude announced that they had developed the first stable glucagon formulation that was ready to inject. They call it Nano-G. Back then, they were actively seeking well-heeled partners to help them bring their idea to testing, FDA approval, and then to the market.

There was one other firm noted in the memo: PhySci. Formerly known as Marcadia, PhySci was acquired by Roche. Since then, not much to report, and I couldn’t find anything on the web about PhySci or Roche glucagon improvements.

In looking into all this, I found out some things, but not nearly enough. I’ve seen a lot, but I haven’t yet seen the actual thing that everyone is shooting for. Truth: Maureen finds the current delivery of glucagon too scary to ever attempt using it. The idea that glucagon can be stabilized and put into a simple pen so any caregiver can administer is an idea who’s time has more than come.

I’ll be watching, and hoping, that glucagon delivery can become as commonplace as just about any other type of injection. I’m rooting for Xeris, and any other outfit who can make this a reality.
 
 
 

CGM Data… how do you feel about yours?

Let me tell you, reading CGM data is hard sometimes.

I don’t usually wear a continuous glucose monitor (CGM), but I’m wearing one for the next few weeks as part of a clinical trial I’m participating in. Every day, I’m fascinated by the data that I’m getting about how my blood glucose handles the food I eat, the workouts at the gym and work around the house, hot days and cool days.

And I hate to admit it, but occasionally it’s sort of affecting how I feel about things as I watch that CGM graph line go up or down.

Saturday, I was so frustrated because it seemed like no matter what I did, I was still sinking under 70 over and over again. That was after a false high reading I was getting early on (second day of the sensor… probably not fully calibrated yet). On Sunday, it was the opposite: I was low continuously for a couple of hours until I had a late lunch a little before 1:00, but high after that for the rest of the day. Despite how I had carefully checked where my BG was, how much insulin was on board, and how much insulin I needed to get back within range.

I’m not talking monster stress here; I mean, hey, diabetes throws us curve balls all the time… these things happen. I’m merely saying that I get mad occasionally when I carefully analyze what I’m doing to manage everything, and I’m still out of range, and I still have to wait hours before I’m back in a good range again.

I know this: CGMs are a great source of information and a huge help in managing glucose levels overall. I also know this: A couple of times in the last week, I would have rather been blissfully unaware of how my BG was trending for a few hours.

I’m working on becoming more comfortable with knowing my BG trends 24/7. It’s a work in progress.

What about you? Are you a CGM user? If so, do you let what it’s showing you affect how you feel about your diabetes? Do you have any tips for dealing with that?
 
 
 

Happy Anniversary, MedWatch!

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MedWatch, the USA Food and Drug Administration’s self-billed “premier safety reporting system” is celebrating its 20th anniversary.

MedWatch is also using the occasion to tout a new web-based learning tool called MedWatchLearn, including a nifty video that gives a lot of information about how to report issues to the FDA. Also, they’re rolling out a new reporting form that supposedly has less technical jargon than the previous form did. I didn’t see the previous form, so I can’t compare. The new one is more “consumer friendly”, but it’s still five pages long.

I know we like to beat up the FDA sometimes, but it’s important to remember that MedWatch has helped inform People With Diabetes about problems with blood glucose meters, the drugs Avandia and Actos, and insulin pump infusion sets. Those issues were reported by someone, and someone at the FDA listened. And then reported on it.
 
 
Here’s a link to the official announcement and the new reporting form:
Announcement: http://www.fda.gov/Safety/MedWatch/ucm353999.htm?source=govdelivery

Form: http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM349464.pdf?source=govdelivery

And of course, you can always reach the Food and Drug Administration at www.fda.gov/medwatch, or by calling 1-800-FDA-1088 (1-800-332-1088).

Happy Anniversary MedWatch… here’s hoping all our drugs and devices work perfectly and we never need to talk to each other again.
 
 
 

The inevitable downslope.

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This is why changing infusion sites in the evening worries me a little.

I changed sites last night around 8:30… Great. I was primed and ready for the #DSMA Twitter chat. About halfway through the chat, The Great Spousal Unit brought me a small bowl of strawberry ice cream with fresh strawberries on top. There were more strawberries than ice cream, but when they’re fresh, I don’t mind at all. Now, where was I? Oh yes… the infusion site change.

So often after site changes, I’ll have a… What do you call it? A phenomenon? An anomaly? An unexplainable variance in The Force? It seems as though the site isn’t working at all for a while, which is why I got a high alarm around 11:30 while I was fast asleep. I’ve been through this kind of thing before, so I knew better than to do a correction bolus at that time. And my BG just kept on climbing, up into the neighborhood of 250 mg/dL at around midnight.

From that point on, however, I started dropping. Again, this is without a correction bolus. Certainly, the ice cream and strawberries had lost a lot of their oomph by then. But I just kept getting lower and lower until I was awakened by a low alarm at around 5:00 a.m. No big deal, because that’s when I get up for work (if I don’t go to the gym first). But I just don’t understand why, at least half the time I change sites, all of the insulin I’m pumping seems to be worthless until all of a sudden it’s not worthless anymore. And then it makes up for it with a vengeance over the next few hours. I’ve seen others write about this, so I know I’m not a weird statistic. But I don’t have a scientific explanation for it yet.

Just to be sure it was the new site and not the dessert that caused my glucose to skyrocket last night, I may have to try the ice cream and strawberries again this evening. You know, just to be sure.
 
 
 

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