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Cellnovo’s mock-up insulin pump promises touch-screen, wireless technology.
Revolutionizing Insulin Pumping: Cellnovo Company Update
A company that has long been in “stealth mode,” Cellnovo recently emerged with a new discreet insulin pump. Dubbed the Cellnovo 150/Cellnovo 50 (the Cellnovo 150 holds 150 units of insulin, and the 50, designed for children, holds 50 units), the pump is substantially smaller than other pumps on the market (about 1.4 in x 2.0 in x 0.6 in) and designed for wearing underneath the clothes. Most enticing, the Cellnovo has no controls and is operated by a touch-screen handheld controller, with a very similar look and feel to Apple’s iPhone – the controller includes a blood glucose meter, “texting” capabilities, and food library, setting the standard for a patient-friendly user interface. Also similar to the iPhone, the device can sense its orientation – and thus determine whether the user is standing, lying, or exercising. While the company opted not to develop a tubeless design, the tubing is very short – only about 4 in long, terminating in a standard infusion set. The pump itself consists of two parts: a disposable pump/reservoir (with a three-day lifespan) and an attached battery/electronics pack.
Though the ultimate design details of the Cellnovo pump are not finalized, the product is expected to be available in the United Kingdom (where the company is located) in early 2010; with no hurdles in the approval process, the company hopes to expand to the US and European Union before the end of 2010. We here at diaTribe will certainly be tracking its progress – for a video preview of the Cellnovo pump, visit the company’s website here.
One of the advances proposed includes “tattoo” glucose monitoring technology – cells fluoresce, reflecting the body’s glucose levels for easy reading.
Advances from Diabetes Technology Society
Recently, the diaTribe team attended the annual Diabetes Technology Society conference here in San Francisco. Several people from academia and the pharma industry showcased various products in development, presenting clinical and scientific updates from recent trials. We heard several discussions on advances in closed-loop devices, which use data from continuous glucose monitors (CGM) to regulate insulin delivery. Diabetes Technology Leadership Award winner Dr. William Tamborlane was positive on the progress thus far. He is particularly looking forward to improved CGM accuracy (currently these devices are less accurate than fingersticks and lag behind actual blood sugar when levels are rising or falling) and solutions to address real-life conditions such as exercising and variable meal times. He pointed to the Medtronic Veo as a promising first-step to avoiding prolonged hypoglycemia. As a reminder, the Veo is an insulin pump that automatically shuts off if blood glucose levels, measured by a CGM, fall below a user-defined threshold and the individual does not respond to alarms; this device is only available in Europe. We also heard more on an “ultrafast” insulin analog in development, VIAject, which acts faster than currently available insulin analogs, better mimicking the body’s natural insulin release. Faster acting insulins will allow for insulin to be administered closer to mealtimes. We expect to hear from the FDA on whether VIAject is safe/effective enough to be available in the US by the end of 2010. Lastly, two novel forms of insulin in early stages of development were reviewed at the meeting: Nasal insulin (CPEX’s Nasulin) and oral insulin (Biocon’s IN-105). Although these various types of insulin remain in development (admittedly with some kinks to be worked out), we are nonetheless excited to see the pharma industry invest in advancing the effectiveness and convenience of delivering insulin.
Dr. Philip Home, chairman of the RECORD Steering Committee. Image source: Medical Economics
Revisiting the Avandia Scare: Results from the RECORD Trial
A few years ago, Dr. Steven Nissen and Dr. Kathy Wolski of the Cleveland Clinic published an analysis of several clinical studies that stirred controversy regarding the cardiovascular safety (risk of heart disease) of Avandia, also known as rosiglitazone (for our coverage of the issue, see Learning Curve from diaTribe #6). Avandia belongs to the thiazolidinedione (TZD) class of drugs for the treatment of type 2 diabetes. Currently, only two TZDs are available in the US and Europe, Avandia and Actos (pioglitazone). Dr. Nissen’s study reviewed data from 42 clinical trials of Avandia to conclude that there is a significant increase in cardiovascular risk following the use of Avandia compared to people who did not take Avandia – setting the mainstream media ablaze. However, many statisticians and physicians vehemently disagreed with the methods and conclusions of the study. We were particularly struck by the attention this study attracted from the media, given the numerous concerns about the validity of the study. Since then, skeptics as well as supporters of Dr. Nissen’s analysis have eagerly awaited the results of a five-year clinical study, RECORD, to validate their respective hypotheses. The RECORD trial evaluated the cardiovascular risk of Avandia in nearly 4,500 individuals and the results were finally presented to an overflowing crowd at this year’s annual meeting of the American Diabetes Association. It found that patients taking Avandia had no overall increased cardiovascular risk compared to those taking metformin or a sulfonylurea. These results clearly refuted Dr. Nissen’s study and reinforced the FDA’s initial decision to approve the drug for individuals with type 2 diabetes. However, it should be noted that results did confirm increased risk of heart failure and bone fractures (particularly in women), suggested previously as class effects for the TZDs – thus, the presenters suggested Avandia should not be recommended for people with a history of heart failure and should be used with caution in women at a high risk for bone fractures. As a side note, Dr. Nissen also conducted a similar review of Actos studies and found no association with increased cardiovascular risk; in fact, some studies have indicated Actos may demonstrate a protective effect on the heart.
Take a S.T.A.N.D. for Diabetes
Start Taking Action Now for Diabetes (STAND) is a new social marketing initiative of Taking Control Of Your Diabetes. STAND is the product of a two-day social marketing summit on diabetes attended earlier this year by diaTribe editor Kelly Close. Its goal is to improve awareness of the disease and promote a healthier environment for its prevention and management.
The needs are obvious: With restaurant menus rarely serving dishes designed for balanced nutrition, with school lunches offering poor choices, and with insufficient public education to help individuals recognize symptoms of diabetes, America is doing a poor job on many fronts in helping people understand diabetes and the importance of blood sugar control. Through social marketing, STAND is designed to address these concerns by forming a community of individuals that will help educate, influence, and motivate others in everyday life. "The diabetes epidemic continues out of control, so we want to use the latest in social marketing to help tame and control this ancient disease,” said Dr. Steven Edelman, the founder and director of TCOYD, who also has type 1 diabetes and was the first member of diaTribe's advisory board. "STAND is a new national movement that uses social marketing to encourage people to think and act differently, ultimately creating a more supportive and influential environment for people living with diabetes. STAND strives to promote health-seeking behaviors and establish blood sugar management as a popularly understood and nationally embraced health goal."
Everyone is encouraged to take the STAND pledge at www.STANDforDiabetes.org and to start a movement among patients and friends to take control of their blood sugar levels today.
The list keeps growing: new documented benefits of exercise.
The Impact of Exercise on Cardiovascular Complications
While the benefits of exercise are well known, a recent study presented at the annual Scientific Sessions of the American Heart Association in November provided some compelling data regarding the effect of exercise on cardiovascular risk. Researchers at the New York Medical College studied individuals with an average age of 70 years who were experiencing chest pain or shortness of breath and had no medical history of heart disease. They found that individuals with lower exercise capacities (defined by the maximum amount of exercise one can perform and the amount of oxygen necessary to do it – often measured using a standardized treadmill test) were 13% more likely to experience myocardial ischemia (lack of blood flow to the heart), 20% more likely to experience coronary artery disease (narrowing of the small blood vessels that supply blood and oxygen to the heart – often leading to a heart attack), 25% less likely to have normal coronary arteries, and 9% more likely to die of a cardiovascular event (i.e., stroke, heart attack). Of most interest was the dramatic benefit for individuals with diabetes: those who have higher exercise capacities have a 48% lower risk of heart attack, stroke, or death. While the study shows the importance of exercise in preventing cardiovascular disease, it also emphasizes the importance of vigorous exercise - vigorous exercise, such as hiking, rowing, dancing, bicycling 10-16 mph, or running 6-10 mph, helps increase exercise capacity. So as we begin to make our annual New Year’s resolutions, there is good reason to have “vigorous exercise” at the top of the list.
Twenty-five year estimates paint a bleak future – and serve as a call to action. Graph reprinted from Huang et al., Diabetes Care 2009.
National Changing Diabetes Program Estimates 44 Million with Diabetes and $336 Billion in Related Costs by 2034
As health care spending becomes an increasing concern, the cost associated with chronic disease – particularly diabetes – is becoming an important issue to consider. A recent study, led by Dr. Elbert Huang of the University of Chicago and funded by the National Changing Diabetes Program, estimated both the prevalence and spending on diabetes over a 25-year period in the United States. The study estimates that the prevalence of diabetes will jump from 24 to 44 million, with diabetes-related spending increasing from $113 billion to $336 billion from 2009 to 2034. While these numbers are disheartening, several helpful insights were made. First, the cost increase over this time period was primarily attributed to the increasing size of the Medicare-eligible population, rather than increasing obesity rates; by 2034, the Medicare-eligible population is expected to account for more than half of all diabetes spending. Furthermore, the incidence of undiagnosed diabetes and obesity in the diabetes population is expected to stabilize or slightly decrease. These findings may indicate that the increased awareness and action at the community level is helping to stabilize the rates of undiagnosed diabetes and obesity. We hope that the identification of the Medicare-eligible population as a growing source of diabetes spending will encourage the expansion of diabetes prevention and management programs targeting this population. We also believe that, at least in the US, healthcare reform will prompt insurers to begin to invest more in people with diabetes staying healthy and avoiding complications (previously, they could elect not to cover patients with diabetes but no longer!).
World Diabetes Day Follow-Up
We were heartened this year by World Diabetes Day, which officially recognizes the growing epidemics of diabetes, diabetes complications, and obesity (see our preview from NewNowNext in diaTribe #18). Every year on November 14th, we pay homage through the World Diabetes Day Monument Challenge: landmarks around the globe are illuminated in blue, the color of the International Diabetes Federation's (IDF) diabetes symbol. Here in San Francisco, the Close Concerns team celebrated under the glow of the San Francisco Ferry Building (one of 1,023 monuments lit up worldwide). This is quickly becoming one of our favorite traditions – gathering with family, friends, and colleagues, lighting candles in support of diabetes awareness, we are always reminded how strong this community really is. We are grateful to be surrounded by such passionate and involved people, and we thank Johnson & Johnson and the Juvenile Diabetes Research Foundation for co-sponsoring our organization of the lighting this year.
Celebrating World Diabetes Day, San Francisco style: the Embarcadero Ferry Building, aglow in diabetes blue.
Photos by Mark Yarchoan.
