new now next
For Valentine’s Day, we are asking you to consider extending your love to children who have diabetes but who don’t have access to treatment and medicine. This week, February 10-February 16, buy one less rose for your valentine and donate those funds to the International Diabetes Federation’s (IDF) Life for a Child (see diaTribe dialogue in diaTribe #7 and sum musings diaTribe #39). Life for a Child helps over 10,000 children by providing insulin and syringes, blood glucose monitoring tools, A1c tests, and diabetes education. That’s wonderful – but IDF estimates that over 70,000 children actually need Life for a Child’s help. Please consider sharing the link and donating at http://bit.ly/SpareRoseSaveChild to ensure that these children continue to have the services that they need.
By IDF’s estimates (and they don’t miss on these research stats!), 80,000 to 100,000 children desperately need more resources to help manage their diabetes – and, in fact, just to stay alive. Life for a Child helps children by supporting established diabetes centers in developing countries, including Bolivia, Ecuador, Haiti, India, Nepal, Uganda, and Zimbabwe, 41 in all. In many of these countries, children are not diagnosed as quickly as in developed countries, which puts them at greater risk not only of long-term complications but also of diabetic ketoacidosis (DKA), which causes early death. Even when these children are diagnosed in a timely way, affordable insulin is in short supply or not available at all, which is the most common cause of death for these youngsters. We salute organizations such as Novo Nordisk, Eli Lilly, and J&J, which have already committed resources to Life for a Child. But we can all pitch in, spare a rose, and save a child. – MN/AB/KC
On January 11, an advisory panel recommended that the FDA approve Johnson & Johnson’s SGLT-2 inhibitor, Invokana (canagliflozin). The panel voted 10-5 in favor of approving the drug for type 2 diabetes. Though the FDA does not have to follow the advisory committee’s recommendation, it typically does. A final approval decision by the FDA is expected within the next two months. As discussed in this issue’s learning curve, SGLT-2 inhibitors improve blood glucose control by causing the kidneys to excrete any excess glucose in urine.
Though the panel’s ultimate decision was to approve Invokana, its members had two main concerns that will likely influence the final approval and label (the label is all the fine print that explains which patients should or should not take the drug, the various details about how well the drug works, the risks involved in taking the drug as assessed by FDA, etc.). First, in clinical trials, Invokana did not have the same effect for patients who have completely healthy kidneys as those patients who have impaired kidney function – that means kidney problems. On average, the drug significantly lowered patients’ A1cs by 0.6-1.2% from an average baseline of 8% without any risk of hypoglycemia. However, the A1c reductions drop to just 0.3-0.4% for patients with impaired kidney function. By the end of the discussion, the panel agreed that there should be restrictions on prescribing the drug to this group of patients, since the efficacy is lower with the same or even more side effects. There was no consensus on what kidney function threshold (known as estimated glomerular filtration rate, or eGFR) should be used to determine eligibility for the drug. Should the drug be approved, we expect the final label will include at least some restriction in this regard.
The second area of heated discussion concerned the potential cardiovascular risks of Invokana. In Johnson & Johnson’s study specifically designed to examine this, a few interesting findings emerged. Although use of Invokana was associated with an overall 9% reduction in cardiovascular events compared to placebo, the risk of stroke appeared to increase with use of Invokana. Since this contrasted with the rest of the cardiovascular data, many panelists attributed this finding to chance. We assume that there will be close monitoring of strokes as well as cardiovascular disease once the drug is approved. Furthermore, the company explained that the cardiovascular benefits from taking Invokana – an increase in the “good” kind of cholesterol, called HDL cholesterol, decreases in blood pressure, improved glucose control, and decreased body weight – would compensate for any heightened adverse cardiovascular risks. Still, the stroke finding, combined with an observed increase in LDL cholesterol (the “bad” kind of cholesterol; see our learning curve on cholesterol in diaTribe #18), led panelists to ask for more cardiovascular data on Invokana to demonstrate its long-term safety.
As she has done previously, diaTribe Editor-in-Chief Kelly L. Close spoke on behalf of patients at the advisory committee meeting. Review her remarks here and slides here. Invokana is not the first SGLT-2 inhibitor that has been submitted for FDA approval; the FDA previously accepted a new drug application from AstraZeneca and Bristol-Myers Squibb for Forxiga (dapagliflozin) in March of 2011, but the FDA denied approval for Forxiga in January of 2012. After gathering additional safety data, the two companies plan to resubmit the drug for approval in the US in mid-2013. In Europe, Forxiga was approved in November 2012. With the FDA panel recommendation for Invokana, SGLT-2 inhibitors are on path to becoming available to US patients in the near future. –MN/AB
At the JP Morgan Healthcare Conference in January, Insulet announced that it has been working with an unnamed company to integrate a CGM sensor directly into its OmniPod patch pump. This means that instead of having separate sites on the body for the CGM/transmitter and insulin pump, both would be located at a single site – that could be a big improvement, depending on how well it works. Clinical trials are expected to start in 2014, and the device may become available to patients in the next two to three years. As a reminder, Insulet’s next-generation smaller pod was recently approved and we expect to see that on the market very soon.
In animal studies, the device has apparently shown accuracy comparable to CGMs like the Dexcom G4 Platinum, Medtronic Enlite, and Abbott Navigator. A key difference with Insulet’s CGM is that the sensor would only be used as long as the patch pump – about 80 hours (the length of insulin’s stability in a pump). Since this is much shorter than all three aforementioned CGMs, and since CGMs tend to get more accurate the longer they are in the body (up to a certain point), we are interested to see how this new sensor performs within this short time frame. Eventually we would expect the pod to be approved for a longer period and with it, this CGM in development.
As a reminder, Insulet was previously working with Dexcom on a CGM integration agreement – the goal was to eliminate the need for a Dexcom receiver and have CGM data sent directly to the OmniPod Personal Diabetes Manager (PDM) handheld. Based on comments made by Insulet CEO Duane DeSisto, the company appears to be less focused on working with Dexcom on this partnership. We hope work eventually starts up again, since we think many Insulet/Dexcom users would appreciate having to carry one less device. Moreover, it would provide an interim solution until Insulet comes out with its own integrated CGM.
Insulet does not intend to make the integrated pump/CGM closed-loop device capable of automatically dosing insulin based on CGM readings. Instead, Insulet hopes the CGM data will arm patients with real-time knowledge, allowing them to better dose their own insulin. The hope is to use smart, predictive algorithms to alert users with green, yellow, and red lights that signify safe, slightly unsafe, or dangerous blood glucose levels. –AB/MN
The Journal of the American Medical Association (JAMA) published a controversial meta-analysis suggesting that people who are overweight (a body mass index [BMI] of 25-30 kg/m2) or class I obese (a BMI of 30-35 kg/m2) do not have a higher mortality risk than those at a normal weight (a BMI less than 25 kg/m2). The study also demonstrated that a BMI of 35 kg/m2 or greater was associated with a significantly higher risk of mortality. The meta-analysis evaluated an impressive 97 studies with data from nearly three million people and more than 270,000 deaths. These findings are certainly contentious, and in our view, represent additional evidence that BMI alone is an inaccurate indicator of overall health.
Along with the meta-analysis’ publication was an editorial by Drs. Steven Heymsfield and William Cefalu that considered other indices when evaluating a person’s health. Previous studies that investigated BMI and risk of mortality showed similar results to this meta-analysis: a 2005 study found no increased risk for people who are overweight, while a 2010 study found a decreased relative mortality risk for people who are overweight.
Unfortunately, while it is easy to calculate, BMI is not a holistic descriptor of an individual’s health. Importantly, it does not include information such as abdominal fat pattern, muscle mass, blood pressure, blood lipid levels, and fasting blood glucose levels – all important contributors to someone’s overall health. For instance, a top athlete with lots of muscle mass might have a BMI in the overweight or obese category, even though they are in tip-top shape. As a result of these limitations, we would interpret these study results cautiously, and encourage readers to speak with their healthcare team about the benefits of maintaining a healthy weight. –MN/AB
Lilly Diabetes recently donated $100,000 to the Diabetes Scholars Foundation, which funds both college scholarships and scholarships for families to attend the Children with Diabetes (CWD) annual Friends for Life (FFL) conference in Orlando, Florida. This is Lilly Diabetes’s second $100,000 donation, and we are elated to see them continue to support Diabetes Scholars’ wonderful efforts. The Foundation recognizes high school seniors who have diabetes and who show excellence in community involvement, activities, advocacy, and leadership. The scholarships go to any freshman that attends an accredited college, and the awards range from $1,000 to $5,000.
For those not familiar with CWD, the organization holds conferences where type 1 kids and their families can connect with other families, learn from experts, and have fun! At the annual conference that takes place in July in Orlando, top researchers, clinicians, and educators discuss the latest technology, the psychological side of diabetes, nutrition, and just about anything else. diaTribe Editor in Chief Kelly has attended FFL eight times in the last decade and absolutely loves the meeting – many diaTribe editors have attended over the years and Adam and Margaret will both be going this July. We had a memorable time at the last Friends for Life conference in particular and cannot wait to attend again this year; we hope we see you there. Orlando might sound a little hard to reach, but believe us, if there is any way you can swing it, we really hope you try.
If you are interested in any of the organizations discussed above and their work, please visit their websites. For high school seniors, the application deadline for the college scholarships is May 15, 2013. For families who are interested in Friends for Life 2013, the deadline to apply for the scholarship is April 15, 2013. We are grateful to Lilly Diabetes, the Diabetes Scholars Foundation, and CWD for their service, and we salute them for continuing to empower and educate people with diabetes. –MN/AB/KC
The giant Consumer Electronics Show, held each January in Las Vegas, had a variety of devices relevant to diabetes and obesity this year. Media buzz surrounded the HAPIfork, which is designed to help users slow down their eating. We had an opportunity to speak with Jacques Lépine, the HAPIfork engineer, and Jean Baptiste Schmauch about their unique utensil. The rationale behind the HAPIfork is that people normally feel full 20 minutes into a meal, and eating slower helps create greater awareness, and ultimately, leads to eating less food. Indeed, there is evidence linking the rate at which people eat to their overall metabolism, and potentially, their risks for type 2 diabetes (for more information, those interested can read the research posted here). Mr. Lépine explained to us that because the fork does not dictate limits on eating, it would not cause a person to feel hungry after meals, which often occurs with calorie restriction.
We think HAPIfork’s simple design and technology represent a novel way to discourage overeating. Rather than relying on motion sensors, the fork measures the number of times contact is made with an individual’s mouth (the specifics: it uses a sensitive electrical circuit that is completed only when the fork is in your mouth). The device has a green light to indicate you are eating at a good rate, and the pre-programmed rate is 10 seconds between each “forkful.” Eating too quickly turns the light red, accompanied by a gentle vibration to alert the user to slow down. The fork also saves data during the meal, including when it occurred, the length of the meal, and the time interval between each forkful. We like that the HAPIfork will be Bluetooth-connected, meaning it can upload information to a smartphone application and an online tracker. It can also be linked to a scale, meaning weight loss data could be combined with behavioral changes in eating habits. We are eager to see studies on HAPIfork or at least to hear about whether it helps people in the “real world” lose weight – its success will depend on that and we haven’t seen enough data yet. Said one of our correspondents: “What makes you think a vibrating fork will cause people to lose weight? I don’t think it will.” We actually love the idea and from our view, it’s all about whether it will help people change unhealthy habits (in this case, of eating too quickly). We shall see; it does sound easy to use as the fork is water resistant and can be washed under a faucet, and it can go in a dishwasher as long as the electronic-key is removed. The HAPIfork will be available through crowd funding sites Kickstarter and Indiegogo in March for $99. You can read more about the HAPIfork on their website. –AA/MN/AB