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The H1N1 virus, up close.
Photo courtesy of the CDC.

H1N1 (Swine Flu) and Diabetes – Don’t Take Any Chances!

The H1N1 virus, or “swine flu” pandemic, has been one of the most talked about issues in healthcare in the past year – it first came to light in spring, 2009. Vaccines specifically addressing the H1N1 virus will become available in late October or early November – and from what we understand, they will be in high demand, as concern over the virus is increasing again. The vaccine will be in short supply, at least initially, and the Centers for Disease Control and Prevention (CDC) has issued a statement that gives priority to certain groups of people who are susceptible to complications from the flu. In a recent conversation with the CDC, we discovered that people with diabetes are considered to be in this high-priority group. The CDC recommends that people with diabetes always take the seasonal flu shot, and that the H1N1 vaccination is particularly important. We thought this issue had blown over, but not at all – so go ask your healthcare team how to get on the list if you have diabetes. And, by the way – the new more exact term is H1N1, not swine flu, as the pork industry took offense.

Note that the H1N1 vaccination procedure is different from flu vaccinations you may have had in the past. The H1N1 vaccination consists of TWO injections, separated by three weeks. You must receive both injections to ensure that you are optimally protected from the virus.

For more information on the flu virus for people with diabetes, visit the CDC’s web page at http://www.cdc.gov/diabetes/news/docs/swine_flu.htm

For information on the H1N1 vaccination, visit: http://www.cdc.gov/h1n1flu/vaccination/acip.htm

JDRF Clinical Trials Connection

On July 29, the JDRF formally launched its innovative new online Clinical Trials Connection service. This service was launched to help patients with type 1 diabetes and family members better understand the clinical trials’ landscape and to inform them so that they can play an active role in the search for better technologies, therapies, and ultimately, a cure. This excellent – and free – service provides descriptions of and access to all free clinical trials worldwide that are registered in the National Institute of Health (NIH) clincaltrials.gov database enrolling those with, or at risk for type 1 diabetes. After filling out a profile on the site, the service will match you with trials you might be interested in based on your age, duration of diabetes, and where you are willing to travel. Talk about customization!

So how does it work? JDRF has worked with VisionTree to search the clinicaltrials.gov database. The trials that involve type 1 diabetes or its prevention are saved, and then additional “search tags” are added to these trials based on study enrollment criteria of age, disease duration, and location of trial sites. After you sign in (all information is kept confidential), Clinical Trials Connection allows you to search by trial location, enrollment criteria, and to compare trials side by side and ultimately create custom reports of trials to save and share with your healthcare team. Less than four weeks after its introduction, more than 5,000 people have registered to be part of this service. This is a win-win-win in our view—it should help patients identify appropriate trials by simplifying the search of clinicaltrials.gov;it helps companies find patients for their research; and it helps doctors and educators advise of trials that may be right for their patients. Ultimately, we believe Clinical Trials Connection has potential to speed approval for drugs and devices. We have just started testing this ourselves and encourage all patients with type 1 diabetes to try it out. The next step: convince another amazing advocacy organization to recreate this tool for those with type 2 diabetes and with prediabetes!

New diabetes drug Onlgyza is now available in both 5 mg and 2.5 mg tablets.

FDA Approves New Diabetes Drug Onglyza

On July 31, the FDA approved Onglyza, and the drug is now available on pharmacy shelves. Onglyza is a DPP-4 inhibitor, the same class of drug as Merck’s Januvia. It is designed to be taken once a day by patients with type 2 diabetes. We were excited to see Onglyza approved in the US because it is one of the first drugs to successfully pass some of the FDA’s new, stricter rules for diabetes drugs about cardiovascular disease and cardiovascular events. (See our story on this evolution here) This means that so far it has not been associated with increased risk of cardiovascular events, but the FDA is requiring the sponsoring company to conduct trials after it is put on the market to confirm this is true. This will add about $50-$100 million to development costs by our estimates. The drug prevents a particular hormone (called GLP-1) from being broken down inside the body, which helps control glucose levels. The DPP-4 inhibitor class is known to be very tolerable and to have very few side effects, though a small percentage of patients taking the drug experienced upper respiratory tract infections, urinary tract infections, headache, rashes and hives. This class of drugs, which includes Merck’s Januvia and Janumet (approved in dozens of countries globally) and Novartis’ Galvus (approved outside the US), has been commercially successful, beyond virtually all initial expectations. We think that is because the drugs are easy to prescribe (few side effects prompt few phone calls) and easy to take (once daily, few side effects) – in today’s market, drugs and devices that sell well must have positive outcomes, no serious safety problems, and are usually associated with simplicity and little hassle.

Byetta LAR Proves Superior to Lantus in Type 2 Patients

Recently, data were reported from the DURATION-3 study comparing Amylin’s Byetta Once Weekly (formerly known as LAR)—the next-generation, once-weekly formulation of the GLP-1 Byetta—to Sanofi-aventis’ long-acting insulin Lantus. The study found that Byetta LAR resulted in greater reductions in A1c, weight, and hypoglycemic episodes compared to Lantus. Specifically, those on Byetta LAR and Lantus had similar A1c drops of 1.5% and 1.3%, respectively, but those on Byetta LAR lost six pounds on average (2.7 kg) while those on Lantus gained three pounds (1.4 kg). There was less hypoglycemia for those on Byetta LAR but significantly more nausea (experienced in about 13% of patients). Insulin use in persons with type 2 diabetes is often accompanied by weight gain and hypoglycemic episodes. Although the American Diabetes Association's current treatment sequence favors the prescription of insulin before a GLP-1, the results of DURATION-3 suggest that a long-acting GLP-1 like Byetta Once Weekly may be an alternative starting point that some should consider.

The new Medingo Solo Insulin Delivery System. The MicroPump compacts the pump base and insulin reservoir together in a disposable (cannula-containing) cradle – thus, with a bad insertion site, only the cradle needs to be changed, rather than the entire MicroPump.

Medingo Solo MicroPump Soon to Be on Insulin Pump Market

On July 28, the Medingo Solo MicroPump Insulin Delivery System was cleared by the FDA. The Solo is a full-featured “detachable” tubing-free pump, similar to traditional, what we call “durable” pumps, but also having some similarities to Insulet’s OmniPod. The Solo differs from the OmniPod in two distinct ways. First, the Solo’s MicroPump is a three-piece design consisting of a three-month reusable pump, a 200U insulin reservoir, and a three-day disposable (cannula-containing) cradle. Second, the MicroPump has an on-pump bolus capability that uses “beeps” to tell the user how much insulin has been given. Like the OmniPod, the Solo uses a wireless remote that enables customized dosing (basal rates, insulin-to-carb ratios, correction ratios, etc.) and stores dosing data. Patients in the market for a full-featured tubeless disposable pump should note that Insulet will be releasing a next-generation pod in late 2010 or 2011 with a noticeably smaller profile (by about 30%) and the same 200U capacity. We look forward to seeing how insulin-dependent type 1 and type 2 patients receive the Solo MicroPump. As we understand it, it will have a small launch in a couple of regions early in 2010, and expand to a larger launch is by mid-2010. Pricing has not yet been set but is ensured to be competitive with existing pumps over four years, and new reimbursement codes are in development.

Dr. Steven Edelman, founder and director of Taking Control of Your Diabetes (TCOYD)

The TCOYD Fall Conference Series

Step up this fall and attend a Taking Control of Your Diabetes (TCOYD) conference, led by renowned endocrinologist, type 1 diabetes patient, and star diaTribe advisory board member Dr. Steven Edelman! Dr. Edelman (University of California at San Diego, La Jolla, CA) received a most prestigious honor at this year's American Diabetes Association annual Scientific Sessions, the "Educator of the Year.” The fall conference series promises on-site health screenings, chances to speak with a host of diabetes specialists, and lectures on all things diabetes-related – be sure not to miss out!

• Milwaukee, September 19
• Santa Clara, October 10
• San Diego, October 24
• Albuquerque, November 21

The 2010 conference schedule will be announced shortly. And stay tuned for an in-depth interview with Dr. Edelman coming up in diaTribe #18.

Note: TCOYD Series TV Season 4 will kick off this November. Watch all previously broadcast shows on YouTube. And, Dr. Edelman recently interviewed diaTribe editor-in-chief Kelly Close on his radio program Diabetes Discourse, produced by Mindeliver Media (www.mindeliver.com). While this program is meant for doctors, any patients interested in regulatory and reimbursement issues can listen to it here. Note that free registration is required.

Economic Downturn Elicits Stimulus Packages from BD and Lilly

The ongoing economic downturn has left millions of people with diabetes across the globe without jobs and, especially in America, without health insurance. Syringe and pen needle maker Becton, Dickinson and Company said recently that as many as 400,000 of these unemployed Americans may have diabetes. In response, amazingly, BD pledged to donate five million insulin syringes and pen needles through Direct Relief, a nonprofit humanitarian medical relief organization, to over 1,000 community health centers and free clinic partners nationwide. This announcement follows Eli Lilly’s decision to broaden income eligibility for their patient assistance programs from qualifying income at or less than 200 percent to at or less than 300 percent of the US Federal Poverty Level (i.e., $44,000 or less for a family of two). We commend BD and Eli Lilly for their commitment to patients – and send many thanks on behalf of diaTribe writers and readers. BD products will be available at participating clinics beginning August 10, 2009. The company has set up a website at www.bd.com/diabetesdonation. Patients who would like to see if they quality for the Lilly program, should visit www.lilly.com/responsibility/programs.

One of the current offerings from Medtronic: the ParadigmREAL-Time Insulin Pump and Continuous Glucose Monitoring System.
Image courtesy of Medtronic

Medtronic Analyst Day

On June 2, Medtronic hosted its annual “analyst day,” hosting researchers who come to hear news about the company. These days are webcast, and we were interested to hear several new and updated diabetes technologies unveiled. Of particular interest was Medtronic’s LGS (Low Glucose Suspend – a technology designed to minimize the risk of hypoglycemia by halting basal insulin when patients reach low blood glucose levels) part of the Paradigm Veo, introduced recently in the UK and Ireland, as well as the Revel Sensor-Augmented Pump (the new pump and CGM platform that includes everything but LGS), the Comfort Sensor (an improved Sof-Sensor slated for 2011), a personal CGM tagged the “Ferrari Project,” designed to replace fingersticks, and a next-generation hospital CGM (iPro Lightening). Medtronic also announced the development of a “patch pump,” which they believe will come to market in sometime after April, 2010. In terms of what the changes are that patients will see soonest, Medtronic said that the Revel will be capable of predictive and rate of change alerts. (The Paradigm REAL-Time does not currently have the predictive alert feature, though the Guardian standalone CGM does.) The Revel will also offer certain features catering to specific patient groups. Children, for example, will be offered a lower minimum basal delivery and patients with type 2 diabetes will receive a larger max bolus and advanced carb ratio calculations. Essentially Medtronic is making the pumps more customizable – always a good idea from our view.

From our view, it is unfortunate for patients and families in the US that Medtronic is still at the “discussions” stage with the FDA for the “LGS” pump when it is already approved in the EU. Given that the product enables an even safer experience for the patient wearing the pump (it turns off if patient doesn’t respond to hypoglycemia alarms), it is a little surprising and disappointing from our view that it can’t move through FDA faster. While safety is most important, of course, we would like FDA to have more resources so they could move innovative products more quickly, making sure, of course, that they are thoroughly tested.

These new developments all appear to be steps toward two major goals for Medtronic Diabetes Care: to lead the closed-loop revolution as well as to lead type 2 patients into using pump therapy.

Rapid-Acting Insulins on the Horizon (Biodel’s VIAject and Halozyme’s Offerings)

As researchers understand more about glycemic variability and as we move closer to the “Closed Loop,” an increasing interest in more rapid-acting insulins has emerged. Several therapies are currently being developed to meet this need. First, VIAject is a form of human insulin combined with certain GRAS (Generally Recognized as Safe by the FDA) ingredients to enable the insulin to more quickly lower blood glucose. Halozyme Therapeutics is designing a therapy called PH20 that is administered with insulin by enabling faster insulin absorption and increased peak insulin concentrations. While PH20 shows exciting potential, it is still in phase 2 clinical trials (see our “Learning Curve” on the clinical trial process here) and so we will look forward to hearing about the next phase. VIAject has finished phase 3 trials, and we will be interested to see how the landscape unfolds for this small Connecticut company. Meanwhile, SmartInsulin, another rapid-acting insulin candidate, is at an even earlier starting point, but has prompted much excitement in the field, including a grant by the JDRF. Overall, we are pleased to see companies expanding the availability of rapid-acting insulins – we believe we could see their use translate into significantly better glycemic control.

NovoLog Label Change

NovoLog users may find comfort in the FDA’s recent label change of this rapid-acting insulin. NovoLog’s label now recommends that it can now be kept in pump reservoirs for up to six days, an increase over the previously recommended two days. The new label also increased the recommended time NovoLog patients should change their pump infusion sets from a minimum of every 48 hours to every three days. NovoLog is now the only rapid-acting insulin with an extended in-use pump time. Although these are only recommendations, and while we frankly believe the majority of pump users may not have followed the previous label religiously, this news should give patients the peace of mind that they can keep insulin in their pump reservoirs longer and change their infusion sets less frequently without sacrificing the quality of their glycemic control.

Natasha’s cookies are available in three varieties: Raisin Amaretto (our favorite – pictured above), Cranberry Orange, and Vanilla Chocolate.

Natasha’s Health Nut Cookies

After taking our first bites of Natasha’s Health Nut Cookies, our first thought was “these aren’t health cookies.” While many health snacks sacrifice the simple pleasures of taste and satisfaction that people most enjoy about food, these gluten-free, low carb (6 g), no sugar added cookies manage to be both healthy and delicious. The secret is that these cookies are sweetened with malitol (a sugar substitute, albeit one derived from corn) instead of sugar – the snacks are made from almond meal instead of flour as well, fortifying them with antioxidants, protein, fiber, and vitamin E. The ones we tried (two boxes were gone from the diaTribe kitchen in one minute flat) had cranberries and raisins too. We will say that one person in the office with diabetes who tried them did find that the cookies "seemed" to contain more than six grams of carbs, as her blood glucose went over her limit, with an immediate reminder from her beeping CGM. Now she calculates as 12 grams of carbs when she eats these and seems to do well – as always, everyone's mileage will vary (some may find Malitol’s fairly high glycemic index to be a problem), but we loved finding a "cookie" that seemed healthier than average for us! To order, call toll-free at 1-866-328-8225 or local at 650-207-3470 and ask for the diaTribe 15% off special.

Shakes, crisps, and bars – the ExtendSnacks family.

ExtendSnacks: Clinically Proven and Delicious

We love ExtendSnacks – this company was founded by Dr. Francine Kaufman, pediatric endocrinologist extraordinaire (and diaTribe advisory board member). If you fight hypoglycemia or weight or hunger pangs or find that too many foods move your blood glucose up way too quickly, you should try these excellent bars, shakes, and crisps (similar to rice cakes). As their site explains Extend Snacks help manage your blood sugar and to boot, they are healthy – they’re cholesterol-free and trans-fats-free and they represent a good source of soy protein and soluble fiber (the ExtendBar Delight formula and ExtendShakes are certified gluten-free as well). Best is, they are good and the company that makes them is serious about healthy living. Several clinical trials have shown some pretty impressive things, among them, that the products:

• Help stabilize blood sugar for up to nine hours.
• Reduce episodes of low blood sugar by 75% (compared to placebo)
• Reduce morning blood sugar readings by an average of 28% (when eaten as a bedtime snack, compared to placebo)
• Help reduce overeating at next meal by 21% (when eaten as a between meal snack, compared to placebo) – we like this one especially!

  How does this work? As we understand it, the underlying cause of these benefits is the long-lasting stabilization of blood sugar that stems from the formula that contains five grams of uncooked cornstarch, protein, fiber, and small amount of healthy fat. See all the research here, enter the lottery for a four month supply here and if you’d like to try them first, order a variety pack here – be sure to use your 50% coupon, available to all who enter the lottery!