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The Calibra Finesse

Can’t Find the Remote Control? No Problem – New Insulin Pump from Calibra Goes the Distance Alone

San Francisco Bay Area-based Calibra Medical recently received clearance from the FDA for the Finesse, an “insulin patch-pen” for type 1 and type 2 diabetes. Of late, we have been seeing more and more technologically advanced pumps featuring remote controllers that are beginning to resemble full-on PDAs. The Finesse takes a completely different approach, eliminating the need for a controller or electronics – the device is mechanically controlled and insulin is dosed right from the patch-pen by simultaneously pressing two buttons. While it is similar in concept to the OmniPod (by Insulet) in the way the user wears the device, there is no handheld controller, displays, batteries, or memory. The Finesse is designed to deliver bolus doses of fast-acting insulin by a quick manual "click" of the pump by the user. A preset dose of 1 or 2 units of bolus insulin can be administered per click (if more insulin is needed than the base preset dose, the buttons are pushed repeatedly - as we understand it, 0.5 and 5 unit per click models will be added in the future). The device has a total reservoir capacity of 200 insulin units, meaning the patch-pen will last at least three days for the typical user.

In our view, the main advantages of the Finesse are its simplicity (once the user is familiar with the device, insulin can be easily bolused through clothing by clicking the buttons - dosing seems like it would be much quicker overall as well), its discretion (the company assured us the device can be worn under most clothing without being visible), and small size (Calibra reported the device to be in the ballpark of 2” long, 1” wide, and ¼” thick - very small compared to the other pumps currently on the market). Because the device is only intended to administer bolus insulin and not basal insulin, users still need to take their daily dose of Lantus or Levemir. And, it will not be an option at insulin initiation or for type 2 users only on basal therapy - but, it will be a technology that could dramatically help those who should be moving to basal-bolus but are avoiding it. To be sure, we believe this patch-pen could be a simpler alternative for patients transitioning from basal therapy to MDI or a more convenient way for patients already on MDI to administer mealtime and correction insulin. We also think patients who have avoided pumps to date due to size might very much like Calibra's look and feel. We look for payors to set reimbursement plans shortly, though we believe Calibra would do a great deal of good related to better adherence of insulin. As we understand it, Calibra is planning to launch the Finesse sometime in 2010. --JS

The Pod goes abroad.

The Insulet OmniPod Goes Abroad

The staff here at diaTribe has had many great things to say about the OmniPod the disposable “patch pump” from Insulet. Our editor-in-chief, Kelly Close, has been a longtime user of the OmniPod (see Test Drive from diaTribe #4 and #16), and we’ve been following the company through many issues of the newsletter. This month, we’re happy to report that Insulet has agreed to work with the Swiss diabetes company Ypsomed to sell the OmniPod overseas. The launch is planned for this June in France, Germany, and the UK – sales in Australia, Belgium, Finland, Norway, Sweden, Switzerland, and the Netherlands will be starting in the second half of the year, and in China during 2011. The OmniPod will join Ypsomed’s very strong “mylife” line of diabetes products. This is great news for anyone in these countries who’s interested in patch pumps. It’s always encouraging to see a new diabetes product like the OmniPod flourish, and we’ll bring you more updates as the company’s progress unfolds. --BM

The NovoPen Echo sports colorful skins, in addition to other child-friendly features.

NovoPen Echo: A Child-Friendly Variation of the Insulin Pen

Novo Nordisk is developing a new variation of NovoPen with modifications specifically for children. Dubbed the NovoPen Echo, which will replace the NovoPen Junior, the device will sport a number of child-friendly features, including memory function and half-unit dosages – as well as colorful skins. As we understand it, the memory function will display when and how much insulin is delivered – offering additional peace of mind for parents, in our view. The available half-dosing option also allows for more precision. Research conducted by Novo Nordisk suggests the Echo was well-received – a recent study of children, parents, and health care professionals in Germany, France and Canada showed that the Echo was preferred over NovoPen Junior and HumaPen Luxura HD due to its ease of use, improved design, and unique memory function. As we understand it, Novo Nordisk hopes to launch the Echo in Europe sometime in 2010, as the device does not yet have FDA approval in the US – if its features sound enticing, or if you’re simply excited about being able to color-personalize your pen, be sure to stay tuned to diaTribe. --KC

The adjustable Victoza pen doses all three 0.6, 1.2, and 1.8 mg doses, to aid in finding the right dose.

New Type 2 Diabetes Treatment Victoza Enters the Market

After months of anticipation, Victoza, Novo Nordisk’s once-daily GLP-1 analog (similar to Byetta), was approved on January 25, 2010, for sale in the US. FDA okayed the drug for both use as an add-on therapy to metformin, sulfonylureas (such as glimepiride), and thiazolidinediones (Actos and Avandia), as well as a single agent for those who aren’t able to tolerate sulfonylureas or metformin. The first of the “next generation” GLP-1 analogs (next-in-line exenatide once-weekly or EQW is up for approval later this month), Victoza has a promising profile in collectively speaking – in addition to lowering A1c about 1% on average, it prompts weight loss of 5-7 pounds (unlike the weight gain seen with sulfonylureas, thiazolidinediones, and insulin), isn’t associated with hypoglycemia, requires a very thin needle gauge, is dosed only once-a-day, and can be taken at any time of day. While studies show less nausea than for Byetta, still about 43% of patients taking the drug did experience some nausea - that said, you can see clever ways around this, such as Carol King's tip of taking it right before sleep to avoid the feeling.

However, while approval spells safe to use, the product will carry a “black-box” warning, FDA’s method for cautioning against potentially serious side effects – in Victoza’s case, medullary thyroid carcinoma, or MTC (a very rare cancer of specific cells within the thyroid gland called C-cells). While signals for MTC still have never been seen in humans (for more background, see diaTribe #15), the drug will not be recommended in those with a personal or family history of MTC or multiple endocrine neoplasia syndrome type 2, a rare genetic disorder that predisposes individuals to MTC. Due to the warning, various post-approval studies will be required of Novo Nordisk, including a 15-year cancer registry, a long term risk-evaluation study, and further preclinical studies - this is in addition to a cardiovascular safety study. And that may be a good thing, as it means Victoza could have lots of supportive safety data in the long run. Overall, we found the FDA’s response very positive – in its approval, the agency stressed the importance of getting drugs on the market that reduced the long-term complications associated with diabetes, and we definitely see Victoza as a step in the right direction (leaders of the FDA said as much in a recent article in the prestigious New England Journal of Medicine). The drug is now available in 90% of US pharmacies nationwide – for one person’s experience with Victoza, see Test Drive in this issue of diaTribe, and if your current therapy isn't working for you, think about asking your healthcare provider about GLP-1. --LR

First Lady Challenges Childhood Obesity

If anyone has the political capital, resources, and momentum to solve the problem of childhood obesity in a generation, it’s Michelle Obama. The First Lady’s announcement on February 9th, 2010, that she would take on this challenge as her signature initiative – with the goal of eliminating childhood obesity in a single generation – pleased many alarmed by the epidemic. One in three children are now overweight or obese, a number that has tripled since 1980.

The initiative will tackle childhood obesity from all angles. First, food, both at home and at school: suppliers of school lunches have agreed to reduce the amount of fat, sugar, and salt in their meals, and Mrs. Obama has emphasized that healthy school lunches must be a priority. “We can’t be fooled by these false choices that we either provide healthy lunches or you have textbooks, but you can’t do both. We have to do both,” she told USA Today. To increase the availability of healthful choices in the current so-called “food deserts” (geographic areas without abundant fruits and vegetables), Obama proposes $400 million in tax credits and other incentives for grocery stores that move into these communities. Second, physical activity: the “Let’s Move” initiative will publicize the guidelines that children engage in at least 60 minutes of activity per day (an ambitious goal in our view, and wonderful to see) and will encourage more activity in schools.

The obesity initiative has been carefully designed, and we applaud the inclusion of so many partners and stakeholders in the work. Of note, U.S. Secretary of Agriculture Tom Vilsack, head of an organization once blamed for cheapening the wrong kinds of foods, high-fructose corn syrup, and a food pyramid that led consumers astray for 50 years before its revision, has signed on to the effort to improve nutrition for children. The campaign has commitments from mayors, medical and business leaders, non-profit groups, foundations, grocery store owners, retailers, and sports teams.

As importantly, Michelle Obama has taken a non-judgmental tone as a down-to-earth parent who can relate to the challenges. As major change will require parents to incorporate healthier habits for families, an approach that empowers families – rather than leaving parents feeling blamed, attacked, or helpless – will be critical.

Dr. Fran Kaufman sounded the alarm regarding childhood obesity with her book Diabesity in 2005; at that time, experts predicted one in three children born in 2000 would have diabetes (and one in two Hispanic girls). If Michelle Obama and the country can reverse the trend, the beneficial effects on health, our health care system, and on taxpayers will be extraordinary. --EK

JDRF Tackles Dearth of Support for Adult Type 1s with New “Toolkit”

We tend to think of people with type 1 diabetes as kids, but in fact, over half of the 30,000 new cases of type 1 diabetes diagnosed each year are adults. And, because children grow up, most of the people living with type 1 diabetes are actually adults. Despite the large numbers, few resources exist to help newly diagnosed type 1s – or even those type 1s diagnosed as children who are now adults. To address this gap in resources and support, the Juvenile Diabetes Research Foundation (JDRF) has developed the JDRF Adult Type 1 Toolkit, a "how-to guide" written by type 1 adults for their new peers.

The JDRF recognizes that children and adults have very different experiences upon receiving their diagnosis. When a child is diagnosed with type 1, the parents are there as advocates and the family is frequently inundated with support and resources to help cope. But adults getting a diagnosis can have a very different experience, one that can be confusing and isolating. The JDRF observed that the lack of resources and support for these adults, combined with confusion about the difference between a type 1 and type 2 diabetes, needed to be addressed, and it seized upon the opportunity to also help build a sense of community for adult type 1s.

The JDRF Adult Type 1 Toolkit is available from any of the 85 JDRF chapters and on the internet at www.jdrf.org/adults. The Toolkit offers information on a wide gamut of relevant topics to an adult living with type 1 – ranging from practical information on day-to-day management, telling friends, managing diabetes in the workplace, considering the impact on relationships, health and parenting, and planning for emergencies. Particularly exciting is the network of other adults with type 1 diabetes offered by the Toolkit. As part of the program, the JDRF has assembled a group of “expert listeners” who are part of the JDRF community and can share real life experiences. --CG

The early design for MannKind’s inhalable insulin delivery device, the “Dreamboat.”

Mannkind’s Afrezza: Count Your Carbs, Dose Your Insulin, and… Inhale!

Recently, MannKind Corporation submitted a “new drug application” for its inhaled insulin candidate, Afrezza, to the FDA. Afrezza, is an ultra rapid-acting mealtime insulin that is inhaled through a small (fits in the palm of a hand) inhalation device. It has been studied in both type 1 and type 2 diabetes and has just received regulatory approval to initiate studies in children with diabetes. MannKind originally applied for FDA approval with the “MedTone” device and is expecting to hear a final decision from the FDA sometime soon. If approved, the company plans to file a supplemental application with the FDA for a second-generation inhalation device, the “Dreamboat,” by June 2010. If MannKind obtains FDA approval for both devices, the Dreamboat could be in doctors’ offices as early as 2011. It’s important to note that Afrezza wouldn’t be the first inhaled insulin to hit the market. As many readers may remember, a few years ago, Pfizer pulled its inhaled insulin, Exubera, off the market; experts cite many reasons, including inconvenient design, confusing dosing instructions, and cost (for more information on Exubera’s downfall, see Learning Curve from diaTribe #7). On the other hand, MannKind has done everything in its power to differentiate Afrezza from Exubera, stressing its ease of use, efficiency, and safety (specifically, the lack of any lung cancer signal). For now, we are staying closely tuned for any updates on the FDA’s decision to approve or deny Afrezza, and we will follow the drug, if approved, through Test Drive. --ST

The 2010 DiabetesMine Design Challenge

Diabetes advocate Amy Tenderich is hosting her third annual DiabetesMine Design Challenge, giving you a chance to win funding to help you further your creativity toward the end of new diabetes products or web applications. This year, there will be three grand prizes to be won – each winner will receive $7,000 in cash, a mini-workshop with experts at the global design and innovation firm IDEO, and one ticket to the Health 2.0 innovation conference held in San Francisco. Prizes of $1,000 cash will also be offered in the “Most Creative Idea” and the “Best Kids’ Concept” categories. Entries will be accepted until April 30th, 2010, and can take the form of either a 2-3 minute video or a 2-3 page document describing your idea and showing a prototype with supporting graphics. We look forward to seeing the innovation that comes from this exciting contest – winners from last year’s contest can be viewed here (we especially loved the integrated mobile phone LifeCase & LifeApp System – this surely seems where the field is heading, led by Amy). For more details on how to enter, see the contest website. --EC