Looking Back at 10 Years and 100 Issues of diaTribe

Happy New Year from all of us at The diaTribe Foundation. Not only does 2016 mark the ten-year anniversary of the diaTribe publication’s very first issue from late 2016, but today marks the 100^th issue of our diaTribe publication! 

Back when we started diaTribe, it was a quarterly newsletter; our 100^th issue wouldn’t have been until 2031 – wow! It later transitioned to a monthly newsletter, and even then, our 100^th issue would have been in 2017. Now, with new issues coming out twice-monthly and new articles coming out even more frequently, we’ve reached issue #100 earlier than we ever could have initially imagined. Thank you to all of our loyal readers who have been with us since issue #1, and thank you (and welcome!) to all of our newest readers! We SO hope you’ve enjoyed consuming diaTribe, which for us has always been a true labor of love.

Looking back at our very first issue from 2006, it’s amazing to see how far we have come in diabetes. We had fun finding the following parallels:

THEN (2006): We were test-driving the Dexcom Short-Term Sensor CGM, which lasted only three days, was not very accurate, and was not really covered by insurance – and was such a VERY important product to come to market, given all that it has enabled!

NOW (2016): CGMs have dramatically improved in accuracy, reliability, and even connectivity, most recently with the Dexcom G5 and MiniMed Connect. We even have FreeStyle Libre in Europe, which is technically not a CGM, but uses the same underlying technology and eliminates fingersticks completely! We’ve also seen amazing progress in automated insulin-delivery including the MiniMed 670G, Bigfoot Biomedical coming on the scene, the “iLet” Bionic Pancreas, UVA DiAs system and more. The closed loop, at least in hybrid form (which is really all we need) is now a matter of “when” and not “if,” and a huge part of that has been the improvements in CGM, along with improvements in algorithms – and further out, we’ve got improvements in speed of rapid acting insulin ahead. We're thrilled about the NIH's $12.7 million investment in a large scale artificial pancreas study clinical study. Now, of course, we are extremely concerned about access, and getting the data that is needed to show the value. 

THEN: We were writing about twice-daily Byetta and the “craze” for a new class of drugs called GLP-1 agonists.

NOW: GLP-1 agonists now come in a once-weekly variation (the field is working toward once-monthly), and SGLT-2 inhibitors have hit the scene (we first covered them in 2007), with Jardiance becoming the first modern-era diabetes drug to improve heart health.

THEN: We were “looking out” for the faster, rapid-acting insulin ViaJect.

NOW: While ViaJect never made it to market, three new insulins got approved in 2015: Sanofi’s Toujeo, Novo Nordisk’s Tresiba, and Lilly/BI’s first-ever “biosimilar” insulin glargine Basaglar/Abasaglar. What’s surprising is how long the market has waited for faster short-acting insulin, and although we feel that came with Afrezza, we’re also much smarter about the slew of things that has to happen to get a product to market successfully (strong FDA label, strong, aligned partnerships, strong data that results in coverage). 

THEN: We wrote that the “verdict is still out” on the inhaled insulin Exubera.

NOW: Speaking of inhaled insulin, Exubera was pulled off the market in 2007, and while there is a new and improved inhaled insulin on the market, Afrezza, the importance of strong partnerships has never been more clear. Afrezza is an excellent model for showing how challenging the commercial markets are today – although it has many patient fans who rave about how much it has helped them, this has come alongside  prescribing hassles, reimbursement challenges, and a cancelled partnership. We hope to see access to this product further improve, though the market is obviously not for the faint of heart. This is unfortunate since we need many more alternatives to traditional “multiple daily injections”. 

But looking back, some things give us a sense of déjà vu; not everything has changed as much as we would have liked! We’re still talking about the increasing need for individualized care – though to a much greater extent today, fortunately! We’re still waiting in anticipation for the stem cell work of Dr. Doug Melton to reach real people with diabetes, with a steady stream of updates from his team and others in the stem cell field like ViaCyte. We’re still hoping for a cure for type 1 diabetes, much better integrated approaches for type 2 diabetes, and of course, the need for diabetes prevention has never been greater

Until then, we haven’t stopped aiming to provide our readers with the most actionable, insightful, and thoughtful information available for free. We have written lots about therapies and technologies and will be striving to research and interpret integrated care more broadly. We want to help everyone make sense of diabetes and make the public more aware of this epidemic, and we can’t do it without your help. We got our 501(c)(3) for The diaTribe Foundation to help in this regard in 2013 and are starting our third year as an official nonprofit to move ahead on this path faster. 

Now that we’ve looked back at the past 10 years, what’s coming next? 2016 is sure to be an exciting year, for The diaTribe Foundation as well as for the entire field of diabetes. While not a complete list, we’ve put together some of the biggest advances in diabetes that we’re looking forward to in 2016. Have any others you’re particularly excited about? Let us know! 

Diabetes Technology in 2016

• Launch of J&J/Calibra Finesse Bolus Patch Device: This “insulin patch” device is a slim, plastic, and worn on the skin for up to three days. It can hold up to 200 units of fast-acting insulin and allows the wearer to take boluses in two-unit increments. See more here.

• Bigfoot Biomedical pivotal trial to start by the end of the year: The first step in bringing the company’s automated insulin delivery system to market.

• BD/Medtronic FlowSmart Infusion Set: The new set includes a catheter that allows insulin to flow out of two places: the bottom (like current infusion sets) and the side (a new innovation). The result? Hopefully more reliable insulin delivery that should especially help patients avoid “silent occlusions,” which are often not detected by the pump and can lead to unexplained high blood sugars in some patients. See more here.

• Lower age indication for Tandem t:slim G4: The t:slim G4 is currently approved for those 12 years and up, the youngest available for a sensor-integrated pump in the US. But Tandem hopes to bring it to even younger children.

• Medtronic’s FDA submission of MiniMed 640G/Enlite 3 predictive low glucose suspend system: The MiniMed 640G insulin delivery system uses a CGM reading to predict hypoglycemia before it occurs so it can suspend insulin delivery to avoid it. It features a new pump platform and has been launched outside the US in Europe, Australia, and elsewhere.

• US Launch of Abbott’s Libre Pro as well as the Abbott Freestyle Libre for consumers: The professional version of FreeStyle Libre is expected to hit the US market in 2016. Libre Pro allows physicians to get comprehensive glucose data from patients over a two-week period. It consists of a small sensor (slightly larger than a quarter) worn on the arm. After applying Libre Pro in the provider's office, it is worn for two weeks, and the sensor automatically records glucose values every 15 minutes. Patients don’t have to interact with the sensor at all, and after returning to the doctor’s office, the sensor data is downloaded to helpful reports. Read more here. We're also eagerly anticipating more information about when FreeStyle Libre will be available for consumer purchase (not just professional use) in the United States. 

• Launch of Dexcom G5 mobile Android App: Dexcom’s G5 CGM system takes the same G4 continuous glucose sensor, adds Bluetooth to a new on-body transmitter, and transmits data to a phone app for viewing the real-time data and getting notifications. Right now it is only available for Apple device, but Dexcom expects to launch Android this year. Read our test drive here.

• New Dexcom insertion system, touchscreen receiver, and smaller transmitter: Dexcom expects to launch all three in the second half of 2016. We’ve gotten glimpses of these products before, though we should learn more early this year.

• US launch of LabStyle Dario all-in-one glucose meter: The Dario system is an all-in-one smartphone blood glucose monitoring system. It consists of a single plastic unit that holds the meter, a lancing device, and a strip cartridge. The meter plugs directly into the headphone jack of a smartphone and operates through the Dario mobile app.

• Launch of new Insulet OmniPod PDM handheld: Insulet’s next-generation, touchscreen, Bluetooth-enabled PDM should become available this year, assuming it is submitted soon and approved within 6-8 months. It will offer a nice step-up from the current design, which hasn’t been updated in years.

Diabetes Drugs in 2016

• Launch of Novo Nordisk’s Tresiba, once-daily, flexible basal insulin: Already approved and recently launched in the US, Tresiba features a flatter profile, less nighttime hypoglycemia, dosing flexibility (any time of day), and fewer injections for those using high doses of insulin.

• US launch of biosimilar insulin glargine Basaglar: Lilly/BI’s Basaglar is biologically similar to Sanofi’s Lantus (insulin glargine), including the same protein and a similar glucose-lowering profile. Biosimilars are exciting because they will be offered at a lower price than standard insulin analogs although it’s hard to say what will happen on the safety front – until there is a multi-year record of safety, there will be questions on this front.

• FDA Decision on Sanofi's injected GLP-1 agonist Lyxumia: Lyxumia is a once-daily injection that will be useful for controlling post-meal blood glucose levels, similar to other GLP-1s like Byetta/Bydureon, Trulicity, Tanzeum, and Victoza. When blood sugar is high, GLP-1 agonists trigger the secretion of insulin, suppress the release of sugar from the liver, and slow the digestion of food. Notably, though Lyxumia is late to market, it paves the way for LixiLan, a combination of Lyxumia and the insulin Lantus.

• Potential launch of GLP-1/basal insulin combinations LixiLan (Sanofi) and Xultophy (Novo Nordisk): These combination, single injection drugs have demonstrated better A1c reductions than either drug alone, less weight gain and hypoglycemia than basal insulin alone, and less nausea than GLP-1 agonists. There's a race on for which will be approved more quickly...!

• FDA submission of Intarcia's ITCA 650: This implantable GLP-1 agonist device lasts 6-12 months and demonstrated impressive results in clinical trials in 2015: an average 1.5% drop in A1c and 9 pounds of weight loss. We learned recently that its cardiovascular outcomes trial was recently finished – we’ll look very forward to hearing the results in the second quarter. 

And all that is just on the products front! We also have many hopes for the field in 2016 on a big-picture scale. As I mentioned in late 2015, there is so much progress yet to be made in terms of access to care and education. Advancements in drugs and devices are just a piece of the puzzle; they will only be able to have true impact if these products can reach patients, and patients can become more engaged in their own diabetes management. What will 2016 bring in the way of prevention, behavior change, and patient and community engagement? These are big questions, and I look forward to advocating for further progress in these areas.

very best,

Kelly Close

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