Type 2 diabetes, I'm Confused.

A good friend said to me, "I don't get where you are with your diabetes. I have heard you say you are type 2, pre type 2 and I am confused."

Exactly. 

I am confused. 

I think that puts me right smack into the middle of the type 2 universe. Confused.

Years ago, at a physical, the GP told me my blood sugar was elevated. Fasting sugar were 108. I laughed. I would kill for my kids fasting blood sugars to be 108. As we talked the Doc said, "You probably know more about diabetes, with two T1D kids, than I do." Maybe,  I probably do know more about living with kids who have type 1 than he does but that isn't what we were talking about. I was confused.

So we talked more.  He referred me to an endocrinologist. It took six months to get in. If this was remotely serious, why the hell does it a half a year to get an appointment? And how do you stay motivated to take action in that half year? Confused. 

The endo was a nice guy. While I was there as much to interview him about being an adult endo for when my kids when they leave Children's Hospital of Philadelphia, as for myself, we talked about my health. We talked about my family history with type 2, that I had come down from 200 to 180 pounds through diet modification, mostly small actions. I told him what my fasting sugars were (hey there are meters all over our house, I was curious.) He said stay the course on diet and work to loose a few more pounds. He said he didn't need any more blood work to know I had type 2 but I didn't need to test fasting blood levels. So keep being good, just a little more of the same, don't test the morning blood sugars, and oh, you are type 2. Confusing.

Since then, I have periodically checked my morning glucose. I became obsessed getting a masters degree in health communication. I ate much better when I was in a nutrition class as part of that program. Much of the nutrition class didn't stick but the idea of looking at meals as a plate did. I try for at least a half plate of green stuff and no more than a quarter of protein. I can do that. But since then I've exercised less and obsessed more as I try to be useful with that degree. Not to long ago I wore a continuous glucose sensor for a week. From it, I know, if I was type 1, I would give myself a larger meal insulin bolus to manage long, slow recovering, post meal spikes.  I have read up on T2D drugs, some I understand, some I don't, some have side effects like weight gain that make it hard to feel successful at controlling health. My numbers are creeping back up. I think, while not perfect, I was more or less successful at what the endo wanted me to do a few years ago.  Yet, I find it really hard, no - almost impossible, to give myself any credit for that success. All I see are the numbers coming back up and feel guilty about and the occasional stress induced Oreo binge.

Yesterday in a meeting, I stared at a muffin off and on all day. I wanted it in all kinds of ways. In the end I didn't eat it. I had a half a plate of green, a little protein for lunch and wanted the muffin. I need help staying successful, not perfect. It's time to do more, more activity, that 'in nutrition class' attention to diet, some kind of meds and mostly I need peers to help take the next steps to be successful. I know this about diabetes - I need help, not to try to go it alone. I'll go back and see the Docs, maybe an educator and be more open with peers.

Maybe I am not so confused.

Thanks for asking. 

FDA EMDAC Public Comments

I had the privilege of offering public comments at the December 12 FDA Advisory Committee meeting for BMS/AZ's dapagliflozin (aka DAPA). My comments were roughly what follows. I say roughly because I know I get lost and stray from the notes. I have tried to bring what portions of my ad-libbing I remember into what follows.

My sincerest thanks to Kelly Close and the team at diaTribe for sharing detailed background material that made it possible to offer informed comments. DAPA has had a complex and carefully scrutinized regulatory path. There were concerning possible signals of risk. Without being able to read though its history it would have been impossible to appreciate the Sponsor's (FDA hearing speak for the pharma companies behind the drug application), FDA's and committee's conversation on those risks. 

My Comments:

Good afternoon. My name is Bennet Dunlap. I have no relationship with the sponsor. My travel here today is at my own expense, including the cost to a good nights sleep of getting up at 4:am to drive down from Philly for this meeting. 

I am a diabetes advocate, a blogger, been a PCORI reviewer and I recently created the StripSafely.com campaign for meter accuracy. I am a member of Diabetes Advocates, an association of diabetes patients and writers. Last time I was here I absolutely slaughtered the name of the drug in question, so this time I’m not even going to try.

Like 26 million other Americans, I live with diabetes. This morning somebody spoke of unintended wisdom. Those of us with diabetes will take wisdom any which way we can.

I often feel that, the conventional wisdom in medical literature projects that diabetes care is easy. Many of us have felt it is not.  We have found  it doesn’t help when – despite our best efforts – we are labeled non-compliant.  Maybe the problem has to do with unrealistic expectations, or maybe the problem has to do with imperfect treatments.

What I am certain about is while all of us with diabetes can benefit from similar diet and exercise, there is no one size fits all approach to good diabetes medications. We need choices to talk about with people like Bob Ratner, (Gesture to Bob who just spoke) our doctors…  and we need innovation.

Which brings me to the purpose of today’s meeting.

Has the sponsor met the safety and efficacy requirements to market their candidate drug and does it present potential heal value to some of us living with diabetes?             

Broadly speaking, the class of SGLT medication is an exciting new opportunity for glucose regulation. The class encompasses four benefits we haven’t seen together before in one diabetes therapy:

- improved glucose, 

- weight loss, 

- less hypoglycemia, 

- and ease of use that comes with a pill. 

Expanding the class with this DAPA increases choice: although there is already one approved for SGLT-2 therapy, a second one would provide obvious benefits from competition, broader education and outreach. 

We all know third party payers love to bid the pharma. companies against each other and a second SGLT-2 would give them a chance to do so in this exciting new class.

As you consider benefits of diabetes medication outcomes, I encourage you to look to endpoints that can create success in patients’ daily lives. In addition to endpoints of lowering A1C, and avoiding cancer and CV risk profiles -  look to endpoints that we can see and feel in our daily efforts to be “compliant.” Medicines that show less weight gain or even loss and less hypoglycemia can help with the phyco-social struggle to stay compliment. 

The safety issues raised at the DAPA first hearing we're quite concerning. Nobody wants to trade blood sugar control for cancer. I appreciate the scrutiny the the agency and sponsor have given to the issues. I was particularly interested in this mornings presentation on the bladder cancer risk and look forward to detailed professional exploration of it this afternoon. 

As Dr Wilding pointed out this morning, we need better treatments. As a patient I worry that regulation creep may inhibit those innovation. That the endpoints move after trials have begun. What constitutes an effective study need to be resolved before the trials start, not after the fact in discussion at an advisory meeting. 

In closing, please remember diabetes care… is self-care. As patients, we see our doctors just a few times a year, maybe for a combined total of an hour, or two if we are really lucky. That leaves us on our own, responsible for self-care the other eight thousand, seven hundred, fifty eight hours a year. 

We could use a hand seeing success in that.  

Thank you very much.

"Don’t Freak Out Over a (T2) Diabetes Diagnosis"

The latest installment of the “Taking Control of Your Diabetes” series is online.

http://myuctv.tv/2012/10/08/dont-freak-out-over-a-diabetes-diagnosis

Nominate @Diabetic_Iz_Me for a Shorty Award #dsma

I am a huge fan of #dsma, the weekly twitter festival of all thing diabetes. (Wednesdays. 9:00 pm eastern time follow the tag #dsma) It is wonderful because Cherise is more wonderful.

You can show a little Love Ya Mean It by nominating Cherise too. 


You can go about it a few different ways:

• Paste @Diabetic_Iz_Me into the form:http://shortyawards.com/category/socialfitness and ad a reason why you nominated her.
• Send a tweet like this: I nominate @Diabetic_Iz_Me for a Shorty Award in #socialfitness because of weekly #dsma chat 4 living well w/ diabetes.
• You can also tweet shorter nominations like this: #shortyawards @Diabetic_Iz_Me #socialfitness she runs #dsma which is my weekly lifeline other diabetics and a variety of topic to live well

The contest wants you to be creative with the reason. A tweet without a reason for the nomination will not be counted. So don't forget that part, OK? We want votes to count.

The rules say a nomination must be relevant to the category. There is an easyone, Cherise is about as relevant to social fitness as is possible. Through #DSMA she helps people living with diabetes live health, fit, spiritual, emotional, rational, and irrational lives with all type of diabetes.

Here part of the category definition:

The #SocialFitness Shorty Award, in partnership with Anthem Blue Cross and Blue Shield’s Health. Join In., honors an individual who helps others to make healthy choices in their lives through their influence on social media. More here.

You can vote for Cherise in as many categories as you want, as often as you want, just make #SocialFitness one of those votes.

Only one nominee and one category per tweet.

ReTweets (RTs) are eligible provided the account and nomination meets all the other requirements.

Voting for Cherise in the same category more than once simply replaces the text of your original vote; it does not count as an additional vote. (Bummer.)


Come on DOC - share the love!

Type 2 Autoimmune - Say What?

A Standford / U of Toronto study suggest that type 2 may have roots in an autoimmune process.

That link is http://med.stanford.edu/ism/2011/april/engleman.html and in part it says:

Nearly all type-2 diabetes drugs marketed today are designed to control a patient’s high blood sugar levels — a symptom of the body’s inability to respond properly to insulin. However, the researchers found that anti-CD20, which targets and eliminates mature B cells, could completely head off the development of type-2 diabetes in laboratory mice prone to the disorder and restore their blood sugar levels to normal.

As I understand this release, and let me be clear - I don't understand it, T cells and B cells inflame fatty tissues. This results in fat cells growing so rapidly that they exceed their blood supply and begin to die. To clean up the dieing cells the immune system creates macrophages. This process of inflammation, dieing and clean up inhibits the remaining fat cells ability to respond to insulin.

The significance is that this suggest a new process for type 2, an autoimmune process. The study suggest treatments based on this autoimmune reaction that are new ways of addressing type 2, specifically an antibody called anti-CD20. This antibody is already approved for use in humans to treat some blood cancers and autoimmune diseases.

Daniel Winer, DM of Stanford says, “We are in the process of redefining one of the most common diseases in America as an autoimmune disease, rather than a purely metabolic disease.”

As regular readers may have guessed,  mice were involved in the studies. How this translates to humans is an open issue. This statement warented it own paragraph in the relaease: "Despite the treatment’s effectiveness in mice, the researchers caution against assuming rituximab will work in humans with established type-2 diabetes."

More Studies are require.

YDMV. 

New Study - Context Matters.

Who Would Have Guessed It?

Roche offered an opportunity to hear the results of a new research study on T2 and self monitoring. Dr. Andreas Stuhr was going to be presenting and being a fan of Andreas, I joining the conference call this afternoon.

This was a study of type 2 diabetics who do not use insulin. There were two groups studied. Both groups had similar access to testing equipment, doctors and heath care visits. The difference was one group used a paper based tool to put the data from blood test into context. Both groups lowered their A1C. So being in a study and having access to a meter and doctors lowers A1C. The group with a structure tool to collect data and talk about it with their health care team had a more significant drop in A1c than the control.

The tool is simply a paper form. It is available free here.  You don’t need a Roche meter to use it but you need a meter. The tool itself is not the conversations with a health care provider.  It may be a place to start.

So while it sounds a lot like "we hold there truths to be self evident" putting context around the data you collect can provide better results.

Context Matters.

/begin disclosureI have been to Roche’s diabetes social media summits. They pay my way. I speak my mind. I suspect there are still photos of my sign from last summer's conference floating around with circles and arrows and a paragraph on the back to be used as evidence against me. (Feel free to link the photo in a comment if you have it, or Alice's Restaurant for the circles and arrows.  As a hint the sign was two words and the words had the same first letters as Blood Sugar.)  Roche invited me back - go figure. They doesn’t push product info at us. So much so that as a group we expressed and interest in hearing news from them. This call to the social media summit group was part of the sharing we asked for. 
/end disclosure