NewNowNext March, 2010

Medtronic Launches a New and Improved Insulin Pump, the Revel

The FDA just approved Medtronic’s latest insulin pump, called the MiniMed Paradigm REAL-Time Revel System – this is Medtronic’s first new pump platform to be approved in four years! This system, just like the previous model of the MiniMed Paradigm REAL-Time, can interact with a continuous glucose monitor (CGM) to display glucose readings on the home screen of the pump. Additionally, the Revel has new CGM-specific features, such as predictive alerts, which tell people in advance that they are heading towards hypoglycemia (compared to standard alerts, which tell people after they have reached hypoglycemic levels) – this is similar to a feature pioneered by Abbott’s Navigator. As we learned in an interview with Medtronic Diabetes President Katie Szyman, in a study recently produced by Medtronic, the predictive alerts built into the Paradigm Revel system allowed patients to improve detection of hypoglycemia by 36% compared to standard low glucose alerts. The algorithms (the formulas that operate the sensor) are also said to be improved – we will watch to see what users say in the dQ&A surveys (if you are not taking our dQ&A surveys to tell companies how you like your diabetes therapies, please write survey[AT]diatribe.us) and will alert the company if users are experiencing improvements! In addition, “alert-based navigation” helps direct the user to a specific menu after an alert is received, a feature intended to assist the user in immediately responding to the alert. We like the sound of this and are eager to see how people like it in “real life.” The Revel can also set insulin delivery rates in smaller increments of 0.025 units per hour (until now, the Animas OneTouch Ping was the only pump that could set insulin delivery in 0.025 unit increments); this precise dosing should be very useful for children and insulin-sensitive adults. Notably, extremely insulin-resistant people with type 2 diabetes will also benefit from the Revel, given its new 1:1 insulin-to-carbohydrate ratio feature, which allows as much as 1 unit of mealtime insulin to be administered for every 1 gram of carbohydrate. As we understand from the company, type 2 patients represent 20% of all new pumpers and are a growing market – if you are type 2 on insulin, you may want to ask your healthcare provider if you could benefit from pumping. Finally, this system offers active insulin on board on the home screen and enables individuals to customize missed mealtime insulin reminders. For more information on the Revel insulin pump, visit the Revel page on Medtronic’s website. --ST

Diabetes + Depression = Diapression

The connection between diabetes and depression has been garnering greater attention recently, and the term “diapression" has been coined by Dr. Paul Ciechanowski to describe the intersection of the two conditions. Diapression is not a clinical diagnosis, but rather a description of the specific characteristics often displayed by people with both diabetes and depression. Dr. Ciechanowski, a well-known psychiatric researcher at the University of Washington, has started a website at www.diapression.com to explain what diapression means and the importance of recognizing it for patients and for healthcare providers. We heard the dynamic Dr. Ciechanowski speak at a recent conference ADA Postgrad, in San Francisco (see this month’s Conference Pearls) – what an eye opener that was! There were several stats we found very troubling. First, we learned that 20%-40% of people with diabetes have significant depressive symptoms. Second, one in three patients will have an episode of major depression - the most significant form of depression - in their life. Last, among people with diabetes, 12% have major depression – this is a whopping two times the prevalence in the general population.

We are very happy about the work Dr. Ciechanowski is doing for patients. First, he points out on his new site that patients with depression may be less amenable to accepting medical help, and thus do not take advantage of medical tools available to them. Worse, patients with depression feel less motivated to help themselves, and have difficulty managing important physiological measures like A1c and blood pressure. Because the two conditions can effectively worsen each other, it is very important for patients to tell their doctors if they are feeling depressed. Dr. Ciechanowski’s site is an excellent starting point to learn about this combination of conditions. --NW

Qnexa: Treating Both Diabetes and Obesity

We recently reviewed three drug candidates for the treatment of obesity – Contrave, lorcaserin, and Qnexa (see diaTribe #18). All three drugs in development: they all have been submitted to the FDA and none are yet approved though some may be by the end of the year. They have demonstrated significant improvements in glycemic control along with the observed weight loss. In particular, we highlight encouraging results from a recent 56-week phase 2 study of Qnexa in 130 individuals with type 2 diabetes. Roughly half of the individuals in the trial received placebo and half received Qnexa treatment. Two-thirds of individuals enrolled in the study had diabetes for a minimum of five years and were on at least two diabetes medications. Once the study was initiated, the placebo arm received “Standard of Care” treatment, meaning that physicians were instructed to actively treat diabetes to the ADA target A1c level of 7.0%. After one year, individuals treated with Qnexa experienced an impressive average drop in A1c from 8.6% to 7.0% (wow!), while those on placebo experienced a drop from 8.5% to 7.4%. In addition, Qnexa was also associated with an average 10% reduction in body weight (roughly 20 pounds). Although these results certainly look promising, further phase 3 trials must be conducted to confirm Qnexa’s effectiveness if the company wants to advocate for its use in people with diabetes who are not overweight. In general, we are pleased to see that drug candidates for obesity are having a positive impact on glucose control. As a reminder, Qnexa is currently being reviewed by the FDA for the treatment of obesity, and we expect to gain more clarity on future plans for Qnexa later this year. --ST

inTouch Program Cleared For Use Without A Prescription

Two major trends in healthcare are the shift toward wireless devices and the use of incentives to promote healthy living. SymCare’s inTouch-diabetes program integrates both of these trends (see our original write-up from NewNowNext in diaTribe #15 for more information). Participants with this program, which is organized through an employer or insurance provider, submit blood glucose readings to the inTouch website via their cell phone. The site then integrates their blood sugar measurements with other laboratory results as well as dietary goals. Using this data, participants can monitor trends with their diabetes, and nurse coaches can explain the results and offer suggestions on what the next steps might be. In addition, participants are encouraged to effectively manage their diabetes with an incentive program through Amazon.com. Until February 2010, people with diabetes needed a prescription to sign up for inTouch-diabetes. But now, the FDA has cleared the program for those without prescriptions, broadening its availability. Although no prescription is needed, the program is only available through certain health insurance plans and employers. To learn more about SymCare, visit their website at www.symcare.com. If it seems right for you, ask your employer! It could help them and you in the long run. --NW

Inside the 40-foot blood vessel.

The Interactive Diabetes Exhibit Kicks Off Its National Tour

The Liberty Science Center in Jersey City (in the New York metropolitan area) will be featuring what sounds like quite a compelling diabetes exhibit from April 1 to May 16 called Diabetes: A Deeper Look. Visitors enter the exhibit through a 40-foot blood vessel, lit with 40,000 LED lights and echoing with the beat of a heart. They then proceed through an enormous cell that demonstrates how insulin facilitates the uptake of glucose into cells. Various exhibits within the model blood vessel teach visitors about the effects of type 1 and type 2 diabetes, the role of insulin, the importance of diet and exercise, and the medications used to manage diabetes. One particularly creative exhibit – called “Who Gets Diabetes” – uses photo-morphing technology to show how diabetes affects people in all age groups, of all races, and from all backgrounds. At the end of the blood vessels is a display showcasing the drug development process all the way from basic research to production of medication. The exhibit could be a terrific way to educate children, and we highly recommend that anybody in the New York metropolitan area take the opportunity to give their kids this unique and engaging look at diabetes. The national tour continues in 12 US destinations through 2012, next heading to Orlando – be sure to check www.DiabetesADeeperLook.com to see when the exhibit will be near you (there are no extra cities listed yet, and we’ll be looking back soon). Diabetes: A Deeper Look was developed by the Detroit Science Center Designs and Exhibits and is sponsored by sanofi-aventis US. --NW