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ADA emphasises role of metabolic surgery for T2DM treatment
The American Diabetes Association has emphasised the important role of metabolic surgery for the treatment of type 2 diabetes in its 2017 Standards of Medical Care published in a supplement in Diabetes Care. The paper discusses psychological health, access to care, expanded and personalised treatment options, and the tracking of hypoglycaemia in people with diabetes. Produced annually by the Association, the guidelines focus on screening, diagnosis and treatment to provide better health outcomes for children, adults and older people with type 1, type 2 or gestational diabetes, and to improve the prevention and delay of type 2 diabetes.
The supplement, ‘American Diabetes Association Standards of Medical Care in Diabetesd2017’, also include the findings of a report on diabetes staging, titled ‘Differentiation of Diabetes by Pathophysiology, Natural History and Prognosis’ (Differentiation), which was published at the same time in Diabetes. Produced by a joint symposium of the Association, JDRF, the European Association for the Study of Diabetes and the American Association of Clinical Endocrinologists, the Differentiation report focuses on β-cell dysfunction and disease stage for type 1 and type 2 diabetes, and outlines approaches to define distinct subtypes of diabetes in order to achieve personalized diabetes care.
An expert team of 16 international leaders examined the current available evidence on the various genetic and environmental routes that ultimately result in diabetes, and how these different pathways may be better characterized to allow precise, personalized treatment for people with diabetes.
“This year, the Standards include critical, new evidence-based additions - psychosocial care, expanded physical fitness, metabolic surgery and hypoglycaemia - all of which can impact effective diabetes care,” said the Association’s Chief Scientific and Medical Officer, Dr Robert E Ratner. “Together, the new Standards and the Differentiation report will guide health care providers and patients around the world in a multi-disciplinary approach to provide a comprehensive, individualized diabetes care plan, a plan that accounts for the whole patient and the many variables that can impact their ability to successfully manage diabetes, and thus leads to improved health outcomes.”
The main recommendations from the ADA on metabolic surgery are:
- Metabolic surgery should be recommended to treat type 2 diabetes in appropriate surgical candidates with BMI>40 (BMI>37.5 in Asian Americans), regardless of the level of glycaemic control or complexity of glucose-lowering regimens, and in adults with BMI35.0–39.9 (32.5–37.4 in Asian Americans) when hyperglycaemia is inadequately controlled despite lifestyle and optimal medical therapy.
- Metabolic surgery should be considered for adults with type 2 diabetes and BMI30.0–34.9 (27.5–32.4 in Asian Americans) if hyperglycaemia is inadequately controlled despite optimal medical control by either oral or injectable medications (including insulin).
- Metabolic surgery should be performed in high-volume centres with multidisciplinary teams that understand and are experienced in the management of diabetes and gastrointestinal surgery.
- Long-term lifestyle support and routine monitoring of micronutrient and nutritional status must be provided to patients after surgery, according to guidelines for postoperative management of metabolic surgery by national and international professional societies.
- People presenting for metabolic surgery should receive a comprehensive mental health assessment. Surgery should be postponed in patients with histories of alcohol or substance abuse, significant depression, suicidal ideation, or other mental health conditions until these conditions have been fully addressed.
- People who undergo metabolic surgery should be evaluated to assess the need for ongoing mental health services to help them adjust to medical and psychosocial changes after surgery.
“With these new guidelines, we can confidently say that metabolic surgery, based on sound scientific evidence, is now part of the standard of care for diabetes management. It’s historic. This has important medical and legal implications for patients, physicians and payers,” said Philip R Schauer, bariatric surgeon and director of Cleveland Clinic's Bariatric & Metabolic Center in Ohio.
The ADA first included bariatric, that it now calls metabolic surgery, only in 2011 when at that time it recommended that bariatric surgery may be considered for adults with BMI >35 and type 2 diabetes, especially if the diabetes or associated comorbidities are difficult to control with lifestyle and pharmacologic therapy.
“The 2017 Standards are completely compatible with the previously ADA endorsed International Guidelines from June 2016. In effect, we now have a double endorsement for metabolic surgery from ADA who is the world’s largest and arguably most influential diabetes organization in the world. Their annual publication sets the standard of care,” added Schauer, a past president of the ASMBS.
In 2016, metabolic surgery was included as a standard treatment option in clinical practice guidelines for people with diabetes, even for those who have mild obesity. The evidence-based guidelines were published in the June 2016 issue of Diabetes Care, and carry the endorsement of more than 45 international professional organizations including the ADA, the International Diabetes Federation (IDF) and ASMBS.
“It has been a long climb, but worth it if we can get more patients treated who could benefit,” he said. “But while these guidelines are endorsed by nearly all major diabetes organizations, they must be adopted by caregivers, patients and payers to have impact. ASMBS should continue to take an active role, along with other medical organizations, in encouraging payers (both government and private) to modify current coverage policy to be compatible with the new standards. This is especially true for eligible patients with BMI30-34 since they are currently not covered for surgery in nearly all current coverage policies throughout the US.”
Additional highlights from the new evidence-based clinical and research recommendations in the 2017 Standards are:
- Due to the greater risk of psychological/emotional stress and disorders in people with diabetes, the 2017 Standards include guidelines on screening adults and youth with diabetes for diabetes distress (unique emotional issues related to the burdens and worries of living with diabetes), depression, anxiety and eating disorders, and provide a list of situations that warrant a referral to a mental health specialist.
- The importance of assessing comorbidities (other illnesses a patient has in addition to diabetes) as part of a comprehensive patient-centered evaluation is also highlighted in the newly released Standards. An expanded list of diabetes comorbidities now includes autoimmune disease, HIV, anxiety disorders, depression, disordered eating behaviour and serious mental illness.
- New lifestyle management guidelines in this year’s Standards include a physical activity recommendation to interrupt prolonged sedentary behaviour every 30 minutes. The Standards now also advise that providers assess patients’ sleep patterns as part of overall diabetes care because sleep quality may be associated with blood glucose management.
- To provide more choices for people with diabetes who also have hypertension (high blood pressure), medication recommendations have been expanded in the Standards to now include four options as first-line treatment. According to the guidelines, any of the four classes of blood pressure medications that have shown beneficial cardiovascular outcomes in people with diabetes, ACE inhibitors, angiotensin receptor blockers, thiazide-like diuretics or dihydropyridine calcium channel blockers, may be used as initial therapy for hypertension.
- Included in this year’s pharmacologic section is a new insulin algorithm, which offers more glucose management options for people with type 2 diabetes. A detailed care recommendation flow chart shows numerous pathways that may be considered for patients using insulin to meet their individual needs and A1C goals.
- Patients with diabetes and cardiovascular disease, which includes anyone with a history of stroke or heart attack, acute coronary syndromes, angina or peripheral arterial disease, are at high risk of serious complications and death. Based on the results from two large clinical trials, the Standards include a new recommendation to consider two specific glucose-lowering medications, the GLP-1 receptor agonist liraglutide and the SGLT-2 inhibitor empagliflozin, in this high-risk population to lower the risk of death. More research is needed to confirm if the heart benefits are a class effect or if the benefits persist in patients without established cardiovascular disease.
The Association has updated guidelines on hypoglycaemia indicating that a level of less than54mg/dl be defined as denoting serious clinically important hypoglycaemia, whether that level is associated with symptoms or not, and that incidences of hypoglycaemia within that range be reported during clinical trials and in clinical practice.
To assist providers in addressing any concerns about medication costs that patients living with diabetes face, two detailed tables have been added to this year’s Standards. Each table gives an estimate of the average monthly costs of glucose lowering medicines, both non-insulin and insulin, though the specific cost to the person with diabetes may vary. To help reduce health disparities, the Standards now recommend people with diabetes receive self-management support from lay health coaches, navigators and community health workers.
The recommendations expand the indications for metabolic surgery to include patients with inadequately controlled diabetes who have a BMI as low as 30.
This article utilised materials from the ASBMS, please click here to see this article.