History in the Making: 2016 Brings New Guidelines for the Surgical Treatment of Type 2 Diabetes Mellitus
A Message from Dr. Philip Schauer
Philip Schauer, MD, is Director of Bariatric and Metabolic Surgery and Director of Minimally Invasive Surgery at The Cleveland Clinic. He is a past president of the American Society for Metabolic and Bariatric Surgery.
Last year, two seminal events in our field occurred: The 3rd World Congress on Interventional Therapies for Type 2 Diabetes and the 2nd Diabetes Surgery Summit (DSS-2), September 28, 2015, in London, United Kingdom. The organizers were Francesco Rubino MD, David Cummings MD, Lee Kaplan MD, and me. Voting delegates included nearly 50 international diabetes experts and the consensus conference was endorsed by more than 30 international scientific organizations. I’m pleased to report that the events were a great success, and we continue to make progress establishing the role of surgery for the treatment of type 2 diabetes mellitus (T2DM). We will soon see history in the making as new guidelines that were crafted from the DSS-2 are officially published and adopted.
The guidelines, which will be formally published in Diabetes Care, are in process of being evaluated for endorsement by many key societies that were also DSS partners, including the American Diabetes Association (ADA), European Association for the Study of Diabetes (EASD), International Diabetes Federation (IDF), Diabetes UK, Chinese Diabetes Society, and Diabetes India. One of the goals of the DSS-2 was to come away with a more universal and broad recognition of and agreement on the role of surgery for T2DM treatment based on the current evidence. We’ve achieved this, and when the new guidelines come out it will be the first time we have international agreement by these influential diabetes organizations on the key role of surgery for patients with T2DM and obesity.
I believe these changes are occurring now because, since the DSS-1 in 2007, we have accumulated more robust data. In 2007, there was only one randomized, controlled trial comparing gastric banding with medical treatment for T2DM, and it was a fairly small study. Now, there are 11 RCTs and nearly all of these have strong evidence favoring surgery over medical treatment for diabetes. These include all of the major operations: gastric bypass, sleeve gastrectomy (SG), biliopancreatic diversion (BPD), and adjustable gastric banding (AGB). This amounts to nearly 1,000 patients with up to five years of follow up. Also, it’s quite remarkable that among all of these patients there was not a single perioperative death, which demonstrates that surgery is a safe treatment option. The reoperation rate was about eight percent. Patients not only had superior glycemic control, but also experienced improvement in other cardiovascular risk factors, including lipids, reduction in medication requirements for T2DM, and quality of life.
Another change from the first meeting that I feel impacted the success of the DSS-2 was that the leadership from the major diabetes organizations were involved in the process—from planning of the meeting to voting during consensus.
One area of the new guidelines that will undoubtedly have a large impact is regarding the role of surgery in patients with BMIs between 30 and 35kg/m2. This is exciting because it means that for the first time we are going to have universal agreement that there is a role for surgery in treating patients with T2DM with BMIs as low as 30kg/m2 (27.5kg/m2 for the Asian patient population) if they meet certain qualifications. This could be a huge win for patients because 65 percent of people with T2DM have a BMI less than 35kg/m2. Under the current criteria, BMI less than 35 is not indicated for surgery. Changing the guidelines will mean that more of that 65 percent, especially those not responding well to medications, will be eligible for surgical treatment.
The biggest change that I see occurring is philosophical—a change in our thinking about surgery as not necessarily an operation that causes weight loss, but as an operation that is a diabetes specific intervention. There is no doubt that surgery causes weight loss and that weight loss, in turn, improves diabetes, but that is not the only mechanism of diabetes improvement, as seen particularly in the bypass procedure. We know there are other factors that are likely contributing to the T2DM improvement.
Another important change we will see in 2016 is at the ADA’s annual meeting (New Orleans, Louisiana, June 10–14, 2016), as it is scheduled to have a bigger focus on surgery. The new guidelines will also likely be discussed at this meeting. Annually, The ADA comes out with “Standards of Medical Care in Diabetes,” which is regarded by many insurance carriers as the standard of care for diabetes. There is a good possibility that the new guidelines from the DSS-2 will influence the ADA’s 2017 “Standards” document. Adoption of these new guidelines by insurance carriers both public and private is likely to follow in 2017.
Surgery for the treatment of T2DM will also be largely covered during the 16th Annual Minimally Invasive Surgery Symposium (MISS) taking place February 23 to 26, 2016, at Encore at Wynn in Las Vegas, Nevada. Francesco Rubino, MD, will be giving a presentation titled, “Consensus Conference Principles: Highlights of London Diabetes Surgery Summit 2015.” Here, we will discuss the key evidence presented at DSS-2, summarize the outcome, and even give a sneak peek of what the new guidelines will look like. If you are attending MISS, I encourage you to explore all topics covered in the Metabolic/Bariatric Surgery Sessions on Thursday and Friday (February 25–26, 2016).
The DSS-2 and the crafting of the new guidelines involved many renown and dedicated diabetes experts and many endorsing international diabetes organizations. It is an exciting time for us as these new guidelines are probably the single most important advancement in the last decade in understanding and adoption of surgery as an important treatment for T2DM.
Philip Schauer, MD