* a competition designed to foster innovation in diabetes design and encourage creative new tools that will improve life with diabetes *
CLICK HERE to review all the details on this competition.
Winners will be chosen this week and announced on Friday, June 20. Here’s your part in all this, Dear Reader:
As noted, winners will be evaluated by a sort of reverse American Idol system: that means we’ll take popular vote into consideration, and the final selection will be made by a panel of judges. We’re looking for high points in three areas:
Efficiency - how well does it solve a real-life problem for people living with diabetes?
Clinical Efficacy – how realistic and applicable is this product from a medical standpoint?
Aesthetics - it’s the look and feel, Baby! How good is the pure design?
So, we’d like to hear from you on which of the 20 submitted design concepts appeal to you the most! Here’s a run-down of the entries:
I slept late on Saturday. And as much of a treat as that was, I knew I was in trouble. I planned to do my big two-hour workout at 10:15am that morning, and now I had just one hour to eat and adjust my insulin dosing. This was going to be tricky.
I tried to do the super-low-carb breakfast, in order to keep insulin requirements down to null, but instead reaffirmed that I just can’t function without my latte — and a little something carby to chew on — early in the day. So I dosed for an estimated two-thirds of the carbs going in, and set a temp basal program for -50% for two hours. This seemed reasonable. I had tried this before with essentially the same menu choices and it had worked.
Well, nuts. About half-an-hour into my “advanced cardio” class (with the insanely loud music), I was SURE that my sunny-side-up eggs were going to come out my ears. It was all I could do to keep on the right foot to “Too Late to Apologize” while grasping my breakfast-bouncing belly. A digestion problem. OK, I can deal. But I was also sweating like… well, like a guy. Still, I trudged through another 15 minutes of bouncing and biceps!! before it dawned on me to check my sugar.
52 mg/dL and presumably dropping [insert expletive]
No wonder I feel like crap! How stupid am I not to notice this? How many more minutes before my legs would’ve given out and I’d have ended up face down on the BoFlex floor if I hadn’t checked?
And for God’s sake, why can’t I just sleep in and eat a late breakfast like other people? Why does everything have to be so complicated?!
So after one entire mini-pack of raisins and several raspberry-flavored glucose tabs (ooh, the stomach!), I managed to crouch on the floor in a sweaty heap and press buttons on my pump: cancel -50% temp basal, and quick-like enable -75% temp basal. I stood up, still feeling fuzzy-headed and pissed off at my diabetes and the world at large, yet was somehow still able to jump — although I couldn’t follow along with the repetition counts to save my life. And I kept thinking: I’m being punished for sleeping in. Diabetics can’t afford such decadence!
I kept thinking about a conversation I’d had at a barbecue the day before, trying to explain diabetes to some well-meaning guy who was shocked to hear how often we need to test our blood glucose. “You know eating and exercising and driving and all those things normal people do without thinking about ‘em?” I asked him. “Well, it’s pretty complicated for us. We have to think about every move we make.” He looked pensive. And then ditched me — so he could actually have some fun at the barbecue, I presume. Yeah.
And I also kept thinking: so is this non-compliance? Not keeping my blood sugars in the perfect range, despite the fact that I have lots of tools my diabetic ancestors never had? Screw that. To all you folks out there who think you know how blood sugar control is supposed to work, let me reiterate: this is NOT EXACT SCIENCE. Shit happens. Fairly often. No matter how diligent we are.
Every day is different, get me? So don’t be getting all judgmental on us. Just nod and smile. Don’t try to get too involved in helping us with our BGs, either.
From my side, I mostly prefer to be left alone to do my thing. Once in while during bad patch (like Saturday), however, I could REALLY use some empathy that is not judgmental.
I guess you could say we’re lucky to have diabetes in an era when people get rewarded for reaching above and beyond the norm while living with this disease. Years ago, who ever singled people out for being inspirational with a chronic illness? Nowadays, we’ve got the Joslin Center honoring folks for longevity with diabetes, Animas Corp. and dLife showcasing diabetes heroes, Bayer with their Dream Fund contest, and as of last year, perhaps the most moving of them all, the new Inspired by Diabetes competition organized by Eli Lilly and the International Diabetes Federation (IDF).
The reason I find this one moving is that it’s a creative expression competition that encourages anyone touched by diabetes (not just patients) to share their stories through visual and written works — essays, poems, art or photography. I bet the organization had no idea what to expect when the entries started pouring in last winter. By the end of March, they had 800 submissions from all over the world, including photos, essays, poems, paintings, and two music compositions. “Some of them just made your heart jump,” a contest spokeswoman told me last week.
Equally inspirational is the fact that in conjunction with this contest, Eli Lilly & Co. has made a $50,000 donation to ADA for scholarships for low-income children to attend ADA diabetes camps. For each entry into the global contest, Lilly is donating money to IDF’s Life for a Child Program, which provides life-saving diabetes supplies to more than 1,000 children in 17 developing countries.
Of course I realize that the contest embodies a big PR campaign for Eli Lilly, with former American-Idol contestant Elliott Yamin (who has type 1 diabetes) acting as the program’s Global Ambassador. I got to interview him in person at the ADA Conference last week along with two of the four grand prize winners. From where I sit, despite the obvious self-promotion, it’s still a wonderful thing the company has done here, pulling together a worldwide program to call attention to life with diabetes (the good and the bad), and those who need help with it the most.
Four judges from the American Diabetes Association — including one mother and daughter pair — culled through all the entries in the last months and rated them on four criteria: relevance, originality, creativity, and narrative. The four “grand prize” winners were officially unvieled at the Eli Lilly booth at the ADA Conference last Sunday.
The day before, on Saturday, I was privileged to meet two of the winners, along with goodwill ambassador Elliott (e-Train) Yamin himself in a personal briefing at the Prescott Boutique hotel near San Francisco’s swanky Union Square.
We were ushered in to a small and quite modest suite with an entourage of PR chaperones. We waited in awkward silence until a silly three-tap knock came at the door. When it swung open, the baseball cap Yamin wore that day and lopsided grin immediately broke the ice. He’s smaller and more compact in person than I would’ve imagined, but also more athletic-looking, and well… just very much a regular guy. If you didn’t know, you’d never imagine he could sing like that!
He told us how he’s been selling blue-circle Tshirts at his concerts, and how some fans actually threw their insulin pumps and glucometers up on stage. “That probably wasn’t a really good idea,” he laughed — a raspy chuckle. He listened attentively and nodded in all the right places as we talked with the winners.
And those winners are, by category…
Child with Diabetes – Erin Tetreault, Idaho
A sweet, creative 17-year-old diagnosed with diabetes at age 9. She’s quite an artist, working with a variety of materials and genres. When she heard about the contest at her mainstay diabetes summer camp, Hodia (for Idaho and diabetes mashed together and backwards, or something like that), she was inspired to express what its like to live with diabetes in the oil painting below, which she calls “Self-Acceptance.”
“Four years ago I would have been too self-conscious to paint my bare stomach with my pump proudly displayed,” she wrote the narrative she submitted with the picture. But because of diabetes camp, “I’ve learned to be myself and not worry if I’m different or not accepted.”
Sitting on the couch at the Prescott, she smiled at no one in particular and said, “People with diabetes need a lot more emotional help - not just with the physical side of it. They need to feel like they’re not alone.” Looking on, Erin’s mom was in tears. Needless to say, I was a mess.
Health Care Professional – Theresa Garnero, California
Theresa is a nurse and diabetes educator — National 2004-2005 Diabetes Educator of the Year — who works at California Pacific Medical Center here in San Francisco. She draws diabetes cartoons for various medical publications including Diabetes Health, and seems to have about a million fun ideas about how to get people feeling better and being more active with their diabetes. I can’t believe I had never met her before.
Sitting next to me on the couch, I’d met my match in terms of dry humor and snappy remarks. Turns out Theresa has a past as a competitive figure skater. Wow. Now she’s a self-described “diabetes junkie” who’s always looking for ways to make diabetes more palatable. “My mission in life is to try to inject a little humor in this thing,” she said. I noticed Yamin was grinning ear to ear.
Theresa won this contest for her design of a playful kids’ game, “Pin the Pancreas on the Piggy” (piggy as in early source of insulin for people with diabetes). My kids thankfully don’t have the Big D, but I had to fight them off the piggy game to get a good look at it myself.
The next day in the Lilly booth I had a quick exchange with the remaining two winners:
Family Member or Friend – Teresa Ollila, Colorado
I know many of you guys have seen Theresa’s knock-out photography work. She’s a mother of two who was inspired by her son’s diabetes diagnosis at age 3. A professional photographer, she decided to pursue “real images — not those slick, smiling-happy images you see all over the commercials,” she told me. Her winning collection of photographs is aptly titled “Living with Diabetes.” Be prepared to sit down when you see it.
Adult with Diabetes – Betsy Ray, Colorado
Betsy just seems like one of those people who eats life. I literally only had about 3 minutes with her, but her energy and focus just shine. She’s had diabetes for 43 years (!), and is now working on a master’s degree in psychology “to serve as a resource to newly-diagnosed children with diabetes.” She says her whole family was touched by diabetes, and explains her inborn desire to help others in her winning essay called “The Journey.”
“Diabetes has grown my spirit in a way that no normal life ever could… It is so far beyond what I was told my life would be that I can only respond to the people I meet by telling them ‘Anything is possible. You are on a journey. How you define it is up to you,” she wrote in her moving poem. Take a read:
These people are truly inspirational. No arguments there. I heard their stories of struggling with diabetes, and I felt happy to count them as my diabetic kin.
And it was Yamin who put it all in perspective: “I just wish more people would step up and do more. We need to get away from these misconceptions about diabetes… Doing this competition is cool because it gives other people a way to identify diabetes with a face, with a real person they can admire.”
* * *
Speaking of inspirational contests, the DiabetesMine Design Challenge winners will be announced this Friday, June 20. Be there.
Finally, a chance to offer a roundup of some of the most intriguing things I saw on the show floor at last weekend’s annual ADA conference here in San Francisco:
* From Medtronic, a prototype of a “baby monitor” device that connects wirelessly with the Guardian CGM system. The idea is that parents would purchase a unit they could plug into the wall and place on their bedside table to view and monitor junior’s BG levels all night. The long-distance wireless signal pickup is enabled by a small powerful transmitter that you plug into the wall in your child’s bedroom, or any room where they will spend time. These look like the little charger packs you plug into the wall to recharge your cell phone, without the wires connecting to the phone of course. Theoretically, you could have one in every room in the house so you could always keep tabs on your child’s CGM results. Could be a Godsend! But still in prototype stage. And although pretty isn’t a priority here, this concept was definitely not touched by the “consumer design” push yet. The unit they were displaying in the Medtronic booth was beige and brown and very “hospital-ish” in its look and feel.
* From Intuity Medical, the new OnQ™ all-in-one glucose monitor that contains the lancets and test strips right on-board. It looks like a largish cell phone, but on closer inspection you discover that everything you need to test is housed within, on a self-contained, multi-test cartridge, which incorporates the lancing device, the lancet and test strip (!) All the user has to do — and this is the amazing part — is hold a finger over the little hole and press, and it pokes you AND absorbs the blood right onto a strip. So you’ve done away with one entire step, along with the fuss and mess of carrying around separate lancets and test strips. Wow! Again, still in prototype stage (not yet FDA approved), and cost is TBD. But I like where they’re going, LCD screen and all.
* From Bayer Healthcare, Precose tablets — not a new drug, but interesting to me because I wasn’t familiar with it before, and my co-author Dr. Jackson tells me it’s “very helpful” for some people with Type 2 diabetes. Precose “tackles the carbohydrate problem… by slowing the digestion of carbohydrates.” While this sounds like GI pain in the making to me, I’m guessing it must be pretty popular based on current lawsuit activity, i.e. fighting over rights to market the generic form.
* Also from Bayer, the upgraded version of its Contour blood glucose meter. This is a no-coding meter that allows patients to select either the “basic” or “advanced” levels of testing, depending on how much you like to play with all the fancy features. It will come in three different colors when it hits the market later this summer. What caught my eye, however, was the new MicroLet2 lancing system they were showing off. For some reason, I’m on a lancing kick at the moment, so I just had to go over and inspect this funky-looking pricker. It’s sort of ergonomic, and is actually designed so that patients can use it with just one hand, I am told. It has a function to “eject” each needle when you’re finished with it, so no turning and pulling and poking yourself when attempting to remove the old one (assuming you do that )
* From BioRad Laboratories, in2it on-site A1c testing device. It’s the next generation of a “box” that offers a quick, accurate, in-office A1c result for every patient. So why doesn’t every doctor treating diabetes have this? Why doesn’t MY doctor have this? Man, I hate going to the lab! I couldn’t find pricing information on the company’s website, but I’m assuming it costs a pretty penny. But talk about improving quality of life with diabetes. Keep me away from the hospital lab, and I am a much happier person.
A couple of approaches to “hold back” Type 1 diabetes, for the very newly diagnosed:
* Diamyd Medical believes it has found and easy and effective treatment to “arrest or slow down the autoimmune process” that normally kills off beta cells so fast. It is an injectable “therapeutic vaccine” given to patients diagnosed with Type 1 within 3 months or less. This Swedish company is currently conducting two parallel Phase 3 human trials with patients aged 10-20 years. Dr. Jay Skyler, chairman of the nationwide TrialNet study, just announced intentions to launch an NIH/TrialNet prevention trial using Diamyd in subjects at high risk for developing Type 1. This is the kind of thing you don’t want to get too excited about, because it sounds so incredible, so I’m sitting on my hands right now (after I finish this post).
* From Protégé Diabetes, yet another investigational drug — teplizumab — designed to reduce or prevent the autoimmune attack that damages insulin-producing cells in the pancreas. The drug is a CD3 monoclonal antibody that may protect the beta cells by attaching to T cells before the T cells can attack your beta cells. “If teplizumab works, people with Type 1 diabetes may need less injected insulin,” the company’s materials state. They’re currently recruiting patients in 10 countries for an international clinical trial. You have to be 8 to 35 years old, diagnosed within 12 weeks of the study start, and willing to receive daily IV infusions of the study drug for up to 14 consecutive days at an outpatient facility. Infusions? Yeeechh. Still, I wish them much luck halting the immune attack.
* And just for fun, a couple of photos of that Lincoln sedan outfitted with Medtonic’s CGMS system that I mentioned on Monday:
Would you, could you, drive your car, watching your blood glucose go so far?
Do you have a great concept for a product that will help people with diabetes live better? Well, you’ve got until midnight this coming Monday, June 16, to tell us about it — and seize your chance to be one of two winners of the DiabetesMine Design Challenge. We plan to announce the results next Friday, June 20.
Just a reminder that we’re accepting entries in two categories: under age 18 and over age 18. Submissions can be in the form of a 2-minute video uploaded to the DiabetesMine Design Challenge Group on YouTube, or a 2-3 page written “elevator pitch” plus supporting graphics, emailed to us HERE.
A quick run-through of the cool entries we’ve received so far:
In VIDEO FORMAT (on YouTube)
BioFlips by StickMeDesigns — stylish used test strip disposal
Compact Case by Diabetes Designs — a smaller case that looks cool with any meter
Glucose Tablet Skins by Thomas, age 13 — fab covers for your glucose tablet case (sample the fun here!*)
Pelikan Sun electronic lancing device — by Pelikan Technologies. OK, this one’s rather more of a commercial for a product already on the market, but I included it anyway because I liked their homemade video. They’re reaching out to the community, so the least we can do is listen.
* Sample Entry:
In PAPER FORMAT (posted via Scribd)
The D-Wallet by Mark Dechand, Kansas — a wallet that can handle all your day-to-day diabetic gear
LanceLight by Sandra Leal, Arizona — a lancet with an integrated pen light that’s simple and can be used with any meter
Wireless Emergency Services Alarm by Mark Brown, California — a bluetooth-enabled “brain” that captures CGM data and automatically calls 911 when necessary
Two winning entries will each receive $1,600 in cash and a free two-hour workshop by IDEO design consultants specializing in health and wellness to help the winners refine their concepts. Winner of the adult category will also win one free pass to the next “innovation incubator” Health 2.0 Conference in San Francisco in October 21-23, 2008.
What We’re Looking For
Entries will be judged on three criteria:
Efficiency - how does it solve a real-life problem for people living with diabetes?
Clinical Efficacy – how realistic and applicable is this product from a medical standpoint?
Aesthetics - it’s the look and feel, Baby! How good is the pure design?
The judging panel includes one MD/Editor from MedGadget.com, one of the prodigious design experts from IDEO, and myself from DiabetesMine — giving you the straight poop from a patient’s perspective.
We’re hoping some more of you have some cool stuff up your sleeves! Please submit yours by midnight PST on Monday, June 16. Release your inner innovator.
For at least three consecutive years now at the annual ADA Conference, we keep hearing about a rumored switchover from the A1c as the gold standard average glucose measurement. Instead, we’ll get something new and supposedly easier to understand: a new measure that more closely reflects the mg/dL (and international mmol/l)numbers we all get on our home glucose meters. This new test is now dubbed the eAG (estimated average glucose).
One of the big news announcements Scientific Sessions this week was the results of a large international study that supposedly underscores the accuracy of the eAG. In this 10-center study, 507 volunteers with diabetes had their A1c translated into eAG readings and compared with their running daily BG results, if I understood the press materials correctly. “Study investigators found a simple linear relationship,” the ADA press release states.
Also stated: “Patients find it difficult to relate the A1c’s percentage of hemoglobin that is glycated (and a goal of under 7%) to the self-monitoring of blood glucose they do at home… To reduce confusion, researchers have conducted a major international study to demonstrate how A1c correlates with self-monitoring.”
The ADA is clearly pushing hard for a massive migration to the eAG, which I find incredibly odd. They’ve even created little red handheld calculators (shown here) that they plan to sell to physicians off their website for easier conversion of A1c values into the “simpler” eAG. You can try their online calculator HERE.
One reason I find this so odd is that just last September, the Diabetes Care Coalition, a consortium backed by the ADA, JDRF and AADE, along with a half-dozen major pharma companies, launched a sweeping “Know Your A1C” public service campaign to get people aware of their A1c and what to do about it. I have to assume they’re just gaining traction with that campaign, so why “reinvent the wheel” by throwing an entirely new measure at an already struggling-to-understand audience?
When you dig a little deeper, you discover that the whole eAG initiative is less about reducing patient confusion and more about a good, old-fashioned standards war between competing associations and scientific factions, with the ADA on one side and the International Federation of Clinical Chemistry (IFCC) on the other — and PWDs caught in the middle.
It seems the IFCC was on its way to creating yet another average glucose measurement that the ADA disapproved of even more, so the organization is preempting that move by jumping on the eAG bandwagon. So much was acknowledged in a press briefing at the conference this weekend.
So whose standards will prevail? And where do we patients stand?
Of course it’s clear to me that far too many patients in this country don’t understand the A1c measurement (which btw is an average measured as a percentage of the amount of sugar attached to your hemoglobin molecules, which are present in your red blood cells). But I’d venture to state that the problem isn’t that the A1c result is expressed as a percentage, rather than a number that matches your home glucose meter (which lots of people don’t use or understand either).
The problem is that too many patients out there don’t even know there is such a thing as a three-month average glucose measurement or what it means to their health. THAT, my friends, is what matters. Why confuse the heck out folks by abandoning a measure that the D-world has known it for 25 years? In addition, so much effort has recently been made to promote the A1c, why kill it now? A nationwide switchover would no doubt be a very costly enterprise.
On top of all that, let’s look at the facts. We Americans do tend to cling to our traditional measurements, no matter how unclear they may seem. Come on, have we switched over to the metric system yet? Who cares that it’s much more logical and intuitive than feet and pints and ounces?
As usual, the annual ADA Scientific Sessions Conference was exhilarating and exhausting. You have to be in awe of such a confluence of the pharmaceutical and technological advancements that enable us PWDs to live happy and productive lives.
But outside of the science and medicine, there’s something else big going on. We stand at the dawn of a new era of patient empowerment that applies “consumerism” to health and medical care in ways never seen before.
Last night, DiabetesMine was proud to host a special “thought leadership” dinner at a fine restaurant here in San Francisco bringing together diabetes industry leaders, Health 2.0 innovators, patient advocates, investors and members of the media.
Our theme was Diabetes Reloaded, which stands for redefining not only the role of technology in managing chronic diseases, but also for the newfound self-confidence and ambitions of 21st century people living with health conditions. What’s special about this new web-enabled world of healthcare? It’s proactive, technology-based, empowered, revolutionary, against all odds, and – if needed – outside the establishment.
Have a look at the video we created for this event and take a moment to reflect on how far we’ve come. I’d love to hear what you all think.
I’d like to encourage you all to capture and embed this video on your own sites or interested communities. You can do this using Vimeo, at the link above.
I’m writing this way too late Sunday night and I’m a little exhausted and bleary-eyed after two 12-hour days of “running the conference.” Sorry, no, I’m not in charge of anything. Just running around the enormous expo show floor and from one briefing to another and connecting with industry people I know and don’t know and marveling at all the technology and drug signage and fanfare and goodies and earnest-looking physicians and pharma gals in their little black business suits. Loads of ‘em.
There’s no lack of news this year, but since DiabetesMine is hosting a special dinner at the conference this time around (that’s tonight!), I’ve had nary a minute to start writing it all up. The rest of this week will be info-packed, I promise.
For today, a quick run-through of some items of interest:
* Is it possible that the Powers That Be having been treating Type 2 diabetics all backwards? Perhaps. This seemed to be the suggestion of Dr. Ralph DeFronzo of the University of Texas Health Sciences Center, recipient of this year’s Banting Medal, the ADA’s highest award for scientific achievement. In his lecture Sunday morning, he stated that newly diagnosed Type 2s should really be started on beta-cell preserving drugs (thiazolidenediones {TZDs} such as Actos or Avandia, and gut-hormone drugs like exenatide {Byetta}) right away, instead of the first-course of metformin and sulfonylureas that is currently conventional D-treatment wisdom. Read the ADA’s official blog, penned this year by Anita Manning, formerly of USA Today, for more details.
* Insulin pumps with color screens, coming your way soon. And I’m not just talking about brightly lit LED screens, like that of the Animas 2020. I’m talking full-color screens with pop-up icons you’ll love to touch. Rather iPhone like, don’t you think? What a concept
* The big guns in pumping are officially chasing Insulet Corp. Medtronic was showing off a glass case with models of its “technology trajectory” — code for future product designs. I wasn’t allowed to photograph the stuff, but let me just say that what they had in there were a bunch of insulin pod prototypes and cellphone-like controller units they hope to craft into a market-storming tubeless pumping system by 2010. Of course, by then Insulet may well have integrated CGM technology into the OmniPod for a complete wireless CGM/pump combo system. That’s what Insulet was hinting at, anyway. And let’s hope so!
* Medtronic was also showing off a car with built-in CGMS. For real! (I’m hoping to get the photos soon) They outfitted a dark blue sedan with a large color GPS screen that’s been configured to pick up the real-time glucose data from their Guardian system. Imagine, your MiniLink transmitting to a screen right in front of you while you drive. Actually, the screen display looked incredibly distracting, i.e. major road hazard as you watch your breakfast muffin peak… but it sure would be awesome to have your automobile be able to alert you to encroaching lows. And no more need to pull over for testing on those long road trips. A futuristic vision, of course, but it sure made a splashy booth display at ADA.
* All four of the Inspired by Diabetes contest winners were announced and on-hand at the Eli Lilly booth for photos and shmoozing, accompanied by super-D-crooner himself Elliott Yamin. (Lots of the male docs seemed to have no idea who he was, but lots of the ladies showed up for autographs “for the kids”). More about the truly inspirational winners here soon.
A few views:
I met Elliott Yamin — live and in person this time. No star attitude at all… just one great dude!
Hangin’ with TuDiabetes Founder (and cool guy) Manny Hernandez and health writer and analyst Melissa Ford
(Click HERE to see Manny’s much higher-quality shot of us)
Wall-to-wall diabetes treatments and treaters. Yipes
You can read the official daily conference newsletter called Dispatchhere.
I’m looking forward to sharing many observances and opinions about what I’ve seen at the conference this year in the days to come. Tune in tomorrow for the details on our dinner event. You might be surprised.
With the big ADA conference underway this weekend, we’re being bombarded with headlines about diabetes clinical trials — first and foremost all the news about the conflicting results of the ADVANCE and ACCORD studies. If you read the details, you’ll find a lot of stuff about randomized, controlled, double-blind, yada, yada, yada studies. Whoa, that’s a lot of jargon to digest. And what does it all mean?
Since clinical trials are so vital to advancements in diabetes treatment, it seemed like a good time to revisitthe “research primer” that Dr. Jackson and I complied for our book. (Research for Dummies? I learned a lot.) Know your jargon and all the announcements will make a lot more sense:
Prospective means that the studies were planned before the occurrence of the events that they measured, compared to retrospective studies, which are conducted to “look backward” and explore events that have already occurred.
Controlledmeans that there is second group of subjects, similar to those who were treated, but who didn’t receive the primary treatment. You need them so you can compare the results of the two groups to better understand what the effects of the treatment were. For instance, if you followed a group of people treated with a pink pill for ten years, you might find that they gained an average of ten pounds. Is this weight gain a direct effect of the pink pill? If you also followed a control group, that didn’t receive the pink pill, you might find that their average weight gain was 20 pounds. Now your conclusion might be very different; it seems that the pink pill might help people keep their weight down. Of course, for the control comparison to be most useful, the groups must be comparable in all risk factors that are important to the topic being studied. For example, here you would want to know that the same number of people in each group live next to a donut shop, or that equal numbers were active members of fitness centers.
Randomizingstudy groups means that a computer program randomly assigns individuals to either the treatment group, or the control group. This compensates for any unknown risk factors that you might not have recognized. Perhaps people with blue eyes are more likely to gain weight than people with brown eyes, and since you are attracted to people with blue eyes, you might unknowingly assign more of them to the study group than the control group. Randomizing eliminates this possibility.
Blinding (or sometimes called masking) adds another layer of protection from biased results. The idea is that research subjects do not actually know if they are receiving the treatment, or if they are part of the control group. In our example above, the control group also takes a pink-colored pill, but one that is a placebo, i.e. contains no active ingredient. In what is called a double-blind study, even the researchers don’t know who’s receiving the real treatment, until the end of the trial, when the “code” is broken, and the data is analyzed. Mystery might just make the whole thing more fun!
NOTE THIS:
Because it is difficult to perform a large-scale, long-duration, prospective, randomized, controlled, double-blinded clinical trial, lots of research uses less rigorous approaches. This is one of the reasons why news reports of research seem confusing and contradictory; does coffee hurt your health or help it? And what about alcohol? Many studies suggest that moderate alcohol consumption may decrease heart problems. But no one really knows, and it is unlikely that we will soon be able to identify large numbers of people in their ‘40s or ‘50s who don’t drink, and then randomly assign some to moderate alcohol consumption for the next five to ten years, and others to total abstinence. Blinding the study would be even more difficult: how could some people drink alcohol without knowing it? You get the idea; some questions are difficult to answer with certainty through clinical studies.
AND THIS:
But regarding the impact of A1c, blood pressure, lipids, microalbumin, and eye exams, the answers are much more clear. There have been large-scale, long-duration, prospective, randomized, controlled double-blinded (with some exceptions where blinding was difficult) trials that confirmed the powerful effects of controlling these factors. Moreover, there weren’t just one or two or even three studies in each area, but multiple studies, all supporting the conclusion that keeping these five factors in a safe range will ensure that you have reduced or even eliminated your chance of developing diabetes complications.
It’s almost annual ADA Conference showtime, Folks, and news announcements are in the air. Here are some initial bits you might like to know about:
* Eli Lilly has announced the winners of its Inspired by Diabetes Contest, notably Theresa Garnero — a San Francisco-based nurse and CDE who’s used her drawing talent to make light of diabetes in cartoon form. Congrats, Theresa!
* Who says nothing is new in the glucose meter market? Actually a number of players are “dumbing down” their products for super-easy testing without all the fuss. This morning my buddies at AgaMatrixannounced the launch of two new meters in their WaveSense product line (along with the Keynote & Jazz models): WaveSense Presto and WaveSense Pro.
The WS Presto is a no-code meter “that consumers can buy at a value price.” That means the test strips don’t require coding, and it costs “considerably less than no code meters from the major brands.” It also boasts “improved ergonomics” and a brighter backlight.
The WS Pro is actually designed for use in hospital and clinical settings, “with added features for increased safety.” I’m not quite sure what that means yet.
I know this all sounds like just a bunch of bells & whistles, but the whole thing about WaveSense is the proprietary technology that improves significantly on the accuracy of glucose testing. Read all about that HERE. Personally, I’m not jumping to switch meters, but I sure do love to see improvements in D-designs, no matter how incremental.
* Speaking of which, you may have heard rumor that a San-Diego based company called Tandem Diabetes Care is preparing to release a new insulin pump in few week. Well, the rumors are true! And that’s all I know about that at the moment, since their website is still under construction.
* In preparation for all the news coming out of this weekend’s ADA meeting, Novo Nordisk has created aninformational podcast, which is nothing short of weird. There’s some good info about GLP-1 drugs and other research advancements, but both the interviewer and interviewee sound computer-generated. If they are real people, they need to loosen up and learn how to sound less scripted
This is why it’s nice to attend industry events in person sometimes: just to experience the actual people behind all the corporate logos that make the stuff that keeps us alive. Stay tuned.
Stumble It!
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Care is preparing to release a new insulin pump in few week. Well, the rumors are true! And that’s all I know about that at the moment, since 
