Close Concerns Weblog

JDRF Continuous monitoring trial receives big win - reported in Europe and published in the prestigious New England Journal of Medicine

We were thrilled to see the highly-respected New England Journal of Medicine (NEJM) report on the JDRF continuous glucose monitoring trial results, almost as if the EASD (the major European meeting that took place in Rome all last week) had planned and sanctioned its release! The study was said by many experts to be extremely well designed and executed with results revealing much needed information about glucose sensor optimization. We see it as a positive for patients, doctors, educators, manufacturers of CGM, and payors - despite it being early in the life of the technology, there are some long-term very bright lights here. In the presentation, researchers went into the data in even more detail than the NEJM offered, and voiced some of their opinions and speculations regarding its consequences. The main news was that the A1c drop was statistically significant for adults, whereas children and teens didn’t see a significant A1c benefit – this from our view had to be tied to usage on the device, where adults used the CGM significantly more than kids and teens. Here’s our take:

What is this trial we keep hearing about? It’s a landmark study that for the first time demonstrates that CGM use can clearly lower A1C by a significant month in a six-month time frame. Health insurers and national health services, take note! The investigators anticipated results well and designed accordingly so that each age group was powered a priori for a 0.5% A1c drop. They also understood that CGM success has a significant behavioral component and gave a lot of attention and support to patients. Patients were either sorted into a SMBG group or real-time CGM usage; patients received education in glucose control and users of CGM had additional training on the devices. They could choose from any device (Abbott’s Freestyle Navigator, DexCom, or MiniMed Real-Time CGM) and were free to switch devices throughout the trial. Patients had several follow up clinic visits periodically in addition to phone support follow-ups.

What were the results? There was a significant improvement in what they call both primary and secondary outcomes with CGM use. After the 26 week study, there was a -0.5% decrease in the adult CGM group from baseline of 8.0% and a tiny 0.03% increase in the control group, combining in a highly significant between-group difference of 0.53%. Significant differences were seen for outcomes as well, with 35% of adults in the CGM group reaching a target of 7.0% compared to about 10% in the control group, 25% in CGM versus 5% in the control achieving a relative drop of ≥10%, and 47% versus 10% seeing an absolute drop of ≥0.5%. Results show that 83% of adults in the trial used CGM > 6 days/wk over the entire six months.  We think what led to these results is that adults figured out how to use CGM to get less hyperglycemia and less hypoglycemia.

Side note: Patients were mostly recruited from some of the top diabetes practices in the USA. Dr. Aaron Kowalski of the JDRF said that although the patients were representative of these practices, they were not “otherwise special” and other doctors concur that patients in the trial weren’t ‘special’ since they all had A1c >7%. We believe excellent support given during the trial made a difference on the results – patients received six in person check-ins and scheduled telephone calls between visits. We do think it’s critical that funding increase for doctors and nurses so they can spend time with patients helping them learn this valuable technology.

Additionally, it was good to see that hypoglycemia did not increase in the CGM group – in fact, it decreased in adults while at the same time A1c also decreased. While the hypoglycemia reduction wasn’t “significant,” the trend toward less hypoglycemia was – this is certainly exciting as we at Close Concerns who had diabetes can attest – we love anything that will help us have less hypoglycemia and have certainly used CGM toward that end. Doctors who presented results at EASD said that hypoglycemia is the biggest barrier standing in the way of better A1cs – this has been said for years and finally there is something that can address these barriers.

Other “secondary” (in science lingo) outcomesincluded the percentage of patients achieving an A1c target of 7%, and those achieving a ≥10% relative or ≥0.5% absolute A1c drop, as well as CGM profiles obtained in both groups at three and six months, data about hypoglycemic events, and questionnaires about patients’ quality of life and the costs/benefits of CGM use. We’ll be finding out much more about secondary outcomes as the data is analyzed – and this trial is actually a one-year trial, so there will be key “one-year” results to see.

What are the next steps? There is still much more extensive work to come, including an analysis of hypoglycemia in 120 patients with A1c <7% (already in the target zone), what they call psychosocial factors (think little family-diabetes conflict, ability to access medical care, etc.) and healthcare economics, and the outcome of the follow-on six-month crossover study, when all the patients  use CGM. After the first six months, patients in the CGM group will continue CGM therapy for another six months, and patients in the self-monitoring blood glucose (SMBG) group will be offered CGM therapy for the same period with a less intensive management schedule. This additional period was designed to allow researchers to examine how long CGM works (this is what they call “durability”) and how long positive effects seen with CGM last and to examine whether CGM use is beneficial even without intensive clinical follow-up.

What’s the future of CGM? The bottom line seems to be that some patients do respond to CGM better than others, and that patient motivation, support and improvements in the devices can make a big difference. It turns out that teens and children in the study used the devices much less than adults did – kids only used the devices 51% of the time and young adults 30%).  We aren’t surprised not to see substantial A1c changes if people didn’t use the devices (!) and it just raises the question that now the technology is here, how can it be made easier to use.  

The results seem to point out that there are ‘requirements’ for success of CGM therapy. Most doctors and interpreters of the trial recommend for patients to learn to react to trends (rather than static, exact numbers). Also, patients must be able to call upon their health care team, and members of these teams should start changing their preconceived notions about diabetes and invest the time necessary for optimal use of CGMs. Although both younger groups saw less of an effect than the adult group, there are several predictors of CGM success, mostly surrounding time using the device and psychosocial barriers, that should be addressed (psychosocial barriers to diabetes care should be addressed anyway!). We’re very positive about the future of this important technology and look forward to further trial results in 2009! Congratulations to everyone who worked on this trial and who participated in it – this is just the start !

Check it out - Tour Now Then Sept. 12

Noah Moore's incredible passion has sent him travelling around the world - performing, educating, and motivating people living with diabetes. He's closing out his 2008 international tour, Tour Now Then, in Portland, Oregon on Friday, September 12.

Interested in a whimsical, fun, and entertaining show? Head to the Ambridge Event Center (300 NE Multnomah, Portland, Oregon, 97232) where the doors open at 7:30pm. There is a sliding scale admission that serves as a fundraiser for TNT's mission of empowering every individual through teaching and performance.

Check out TNT for more information!

The Modern Man's Guide - New Men's Health Diabetes Education Campaign

The American Diabetes Association (ADA) has launched a new men’s health education campaign to help bridge the gap and reach men with diabetes. Their goal is to provide tools and resources to take a “modern” approach to managing diabetes in every day life. A survey of 1,000 men showed that men with type 2 diabetes often feel sad or grumpy, get less enjoyment out of life, and feel like diabetes negatively impacts their sex lives. Good for ADA for bringing this stuff out of the closet.

Notably, most men were unaware that diabetes and related conditions can affect their emotional and sexual health. With symptoms such as depressed mood, erectile dysfunction and fatigue, men with low testosterone may feel too frustrated, unmotivated or unaware to discuss disease-related complications with a doctor or lover, further diminishing their ability to take a proactive approach to managing their diabetes.  Some of the new ADA resources target men who are seeking male-specific health information including practical diet and exercise tips, information on sleep apnea, and other information on physical, emotional, and sexual health.

How exactly do you bridge the gap towards men? The ADA is trying with a new “Men’s Health” page on the ADA’s Web site. (Side note – we’re excited to catch a glimpse of the makeover to www.diabetes.org, where some of the pages and content have already transferred, like Men’s Health. Excellent. Stay tuned for further thoughts!) The ADA also created “The Modern Man’s Guide to Living Well with Diabetes” handbook, which can be downloaded from the site. At first glance, it has a lot of good information for men that could help enable many to make small, daily changes. We hope lots of primary care doctors, endocrinologists, and educators hear about this page, because sometimes it’s easier to learn about this at leisure rather than in a medical appointment, especially if time is limited as it so often is in the US system (especially after talking about blood glucose and cholesterol and blood pressure…) It’s great to see this resource come alive - after all, the survey results showed 60 percent of men wanted more information about conditions related to diabetes that would help them manage better overall. We second that! We do wish they had shortened the guide a bit; 36 pages may intimidate men who already feel overworked and overwhelmed by diabetes care. It does look like a guide that can be taken page by page…

Overall, we are excited about ADA’s take-charge stance on reaching out and closing the information gap for men. We hope they continue to be proactive and help others – particularly those falling through the cracks of diabetes care (young adult and transition support anyone?? Pregnancy? Elderly?).

Sweet Home Alabama – “Does your conscience bother you?”

Straight from Dothan, Alabama is a report of Alabama state employees being required to pay a $25 fee every month for health insurance if they are obese. Yes, a $300 annual premium is a lot – if you are a state employee accustomed to free health insurance. For some of the rest of the nation, it could seem like chump change for premium coverage – all depends on perspective, we think.

The Alabama obesity plan is still in the works, but it sounds like the fee will be charged to employees whose BMI exceeds 35 – note that this is five points above the threshold marked for obesity. A woman who is 5’5 with a BMI of 35 weighs about 210 pounds, while a 5’10” man with a 35 BMI weighs approximately 243pounds. Progress to a BMI below 35 results in a rescinded fee.

While reports suggest some employees are outraged at the new requirement, a recent New York Times piece on this subject shows smokers already pay a $24 monthly fee which is increasing to $25 starting in October. 

We’ll put our cards on the table and say that even though we believe many people with BMIs are treated unfairly, we think this premium is A-OK – we would say it’s a positive overall or at least a step worth testing. From our view, Alabama is asking employees to pay now and save later; their research suggests people with BMIs greater than 35 generate more than $1,700 per year in additional health care costs. Our country just can’t sustain that, full stop.

 Alabama is legendary for its obesity and diabetes and overall, we applaud the state government for taking a proactive role and attempting to help the state get on its feet and out of the #2 spot for obesity and diabetes (right behind Mississippi). Approximately more than 30 percent of the state is categorized as obese, more still are considered overweight, and 10 percent of the entire population also has diabetes. Houston, we have a problem! These figures compare to average figures for the US of 30 percent obesity and eight percent with diabetes. Those are figures that need to be on the decline too but especially the states with the worst percentages for diabetes and obesity need help now.

Our suggestion for the angry, overweight state workers? Get a move on it! Do whatever you can to start exercising and making better nutrition choices. The Dothan editorial recommends that even with a conservative weight loss of three pounds a month, someone who is diligent in switching to a healthy (or even just healthier) lifestyle could lose as much as 50 pounds by the time the obesity surcharge takes effect in January 2010. We know that small changes in diet and exercise can make a big difference.  There have been previously initiatives such as “Scale Back Alabama” and we look forward to the return and increase in public education and awareness programs.

We’re also curious to check out if the state insurance policy covers weight loss or weight reduction surgery and how many people will move to take advantage of this before January 2010. It’s been shown in studies that diabetes completely resolves in many patients who undergo surgery. While long term data still needs to be shown, it’s certainly something to take a closer look …

JDRF Continuous Glucose Monitoring Trial Results to be Announced in Rome on September 8

Exciting news for continuous glucose monitoring (CGM) watchers: Much of the diabetes world is descending in Rome over the next couple of days for the big European Association for the Study of Diabetes (EASD) meeting happening starting tomorrow! We'll be there covering the meeting for our publications. On an exciting note, we have just confirmed the JDRF continuous glucose monitoring (CGM) trial results will be presented Monday at noon Rome time.  See below for the all-start lineup for this session. The session will include background on the trial, information on how it was designed, data on what happened in the trial, implications for patients, and what is sure to be a closely-watched panel led by influential pediatric endocrinologist Dr. Bill Tamborlane of Yale. We see this session as very relevant for further progress on reimbursement and CGM uptake. (Sidenote - if you want to wear CGM and have Humana insurance, they just published a positive new coverage issue on CGM - click here for details.)

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JDRF TRIAL ANNOUNCEMENT SCHEDULE
There will be a presentation of the first results from the Juvenile Diabetes Research Foundation (JDRF)-funded human clinical trial investigating the efficacy of continuous glucose sensors on diabetes control.
 
JDRF Study Group: Presentation of JDRF Study Group Primary Cohort Six Month Outcome Data
44th EASD Annual Meeting Rome, Italy
Monday 8 September, 12.00 - 14.00 hrs
Domizia room in Hall 10 of the Fiera di Roma.
 
MEETING AGENDA
 
BACKGROUND/RATIONALE
·         Aaron J. Kowalski, Ph.D., JDRF (moderator)
 
STUDY DESIGN
·         Jean Lawrence Sc.D., Kaiser Permanente Southern California
 
PRIMARY OUTCOMES
·         William Tamborlane, M.D., Yale Medical School
 
SENSOR OUTCOME DATA
·         Howard Wolpert, M.D., Joslin Diabetes Clinic
 
IMPLICATIONS OF RESULTS FOR ADULTS WITH TYPE 1 DIABETES
·         Irl Hirsch, M.D., University of Washington
 
IMPLICATIONS OF RESULTS FOR CHILDREN WITH TYPE 1 DIABETES
·         Lori Laffel, M.D., M.P.H, Joslin Diabetes Clinic
 
PANEL DISCUSSION
·         Moderated by W. Tamborlane (all speakers)

Hitting the panic button – diabetes, Byetta, and pancreatitis

So there have been a lot of headlines lately about Byetta and pancreatitis. We think these headlines have created unnecessary alarm for patients and believe that the facts haven’t been well stated. Thirty-six patients have reported pancreatits, including six that have died. But more than one million people have been on Byetta.

Consider the context: in the population of people without diabetes, 1 in 3,000 would be expected to develop pancreatitis, compared to 3 in 3,000 for people with diabetes. So doing the math, if 1,000,000 people have taken Byetta, it would be expected that about 1,000 people would be expected to get pancreatitis. Unfortunately, it’s not that uncommon. Worse, there are lots of other drugs that can cause it, like blood pressure and epilepsy medicines.  We never ever take patient safety lightly, but it's fair to say we also care greatly about patient access to medicine. Access to Byetta might be reduced because headlines could affect how doctors evaluate risk – especially articles that provide little context. 

Some more context. Every day in the US, 4,100 people with diabetes are diagnosed, 55 people with diabetes go blind (fifty-freaking-five!), 120 people with diabetes are put on dialysis, 230 people with diabetes find out they need an amputation, and 810 people with diabetes die.  They die for many reasons, but the most tragic in our view is that they never received the right education or medicine or, for whatever reason, could not adhere to their medical program. (Some say, “Oh that patient was not compliant,” as if is their fault. We hate that word.)

We know 80% of type 2 diabetes would disappear if we could make obesity disappear. Six deaths due to any complication of diabetes over two and a half years is awful but not because it might be related to a certain drug - it's awful because this happens to people with diabetes in general and it likely could have been prevented with the right education and therapy. So for the headlines to scream about six deaths for people on Byetta – how about all the other deaths that are happening that no one is writing about? Given that, we care most about good treatments to which patients can more easily adhere.  According to many on our diaTribe advisory board, patients often stop taking drugs if they make them gain weight, if they cause hypoglycemia, etc. – these are two things that Byetta doesn’t do, and so we applaud its relatively minimal side effects. Byetta can also cause nausea, which is clearly a negative for those patients that experience this – we are happy to learn that the “next generation” Byetta has 30% less nausea associated with it.

Last, we think it’s important to look at details. For example, five of six deaths being written about had lots of confounding variables – for example, patients had gallstones, leukemia, or were severely obese,

With headlines like “Patients dying on Byetta,” it sounds like Byetta is being blamed – based on the numbers that would be expected to develop pancreatitis for those with diabetes (3 in 3,000), we think that is misleading.

If the press wants patients to hit the panic button, it should suggest doing so over the millions of patients globally who develop diabetes each year (over a million in the US alone each year), over a medical community incapable of providing adequate care (over ten million people with diabetes have an A1c over the ADA target), and a society that can’t pay for poor outcomes. That is far better than scaring patients and PCPs with useless chatter about inconclusive data and made-up epidemiology.

Gila River Indian Community hopes water will wash out diabetes epidemic

Nearly a century ago the Gila River was siphoned off by farmers, leaving a dependent Indian community stranded from natural resources for farming and plunging them into starvation. The U.S. government provided aid – in the form of white flour, lard, canned meats, and other processed foods that combined with the Indians’ genetic disposition started an epidemic of diabetes in the community (one of the highest in the world). Ack.

Recently, a settlement was reached so that the Indians in the community are getting some of their water back. The question is – is it too late?

Many tribal members worry about turning the reservation back to farming after generations have sought alternative lifestyles that include fast food and little exercise.  Here's a stat that shocked us - more than 50 percent of the adult population over the age of 25 have diabetes. In comparison, a sister tribe in Mexico that continued farming and eating natural food have “normal” rates of diabetes and obesity, compared to the Pima population. (We hesitate to categorize such large amounts of diabetes today as “normal” but in direct comparison we see their point.)

The reservation has discussed farming on 40 percent of its acres and still plans to avoid large housing developments, which will double the amount of farming and will be a cultural and economic “boon” to the community. Currently, a community garden of only two acres exists and provides vegetables like squash and beans.

One of the founders of the garden, Ed Mendoza, described relearning to grow gardens and reimpliment farming in The New York Times: “People get sick with diabetes, they’re obese, and there are heart attacks and stress because we eat an American diet now. Beans regulate the highs and lows of sugar. Okra makes you healthy. You can eat this food and feel the spirit immediately.”

We hope that farming and returning to a diet increased in natural foods will help the community and simultaneously set an incredible example for our nation in a time of daily fast-food runs. We need more gardens everywhere - or how about some federal subsidies for buying vegatables. Obama? McCain? Hello?