Both the 2012 and 2015 ADA/EASD Position Statements (1,2) include a visual diagram stressing the importance of continued emphasis on lifestyle modification throughout the course of diabetes treatment, although lifestyle modification is not proven to improve CV outcomes (31). This algorithm for the comprehensive management of persons with type 2 diabetes (T2D) was developed to provide clinicians with a practical guide that considers the whole patient, his or her spectrum of risks and complications, and evidence-based approaches to treatment. Work to find helpful tips and diet plans that best suit your lifestyle—and how you can make your nutritional intake work the hardest for you. Defining and diagnosing type 2 diabetes. However, data regarding the durability of these drugs are still limited (55,56). Since there are many options for the treatment of diabetes and since the risk of hypoglycemia and weight gain is an important hurdle in achieving glycemic control in patients with type 2 diabetes, as is also stated in the ADA/EASD Position Statement (2), we consider these two requirements to be a prerequisite for qualification as a recommended second-line treatment option. Since most oral antidiabetes drugs only reduce HbA1c by <1%, when HbA1c is significantly elevated above goal, only combination therapy or use of injectable agents (insulin and/or GLP-1 RAs) can reduce HbA1c to target. Pharmacologic Approaches to Glycemic Treatment of Type 2 Diabetes: Synopsis of the 2020 American Diabetes Association's Standards of Medical Care in Diabetes Clinical Guideline Ann Intern Med. Should we maintain treatment once a patient has achieved or even exceeded his/her specific glycemic target? Can J Diabetes 2016;40:120–125, U.S. Food and Drug Administration. One of the most important aspects of all guidelines, well represented in the ADA/EASD Position Statement, is the setting of timelines for when to progress from one step to the next (53). 1.7.13 Offer men with type 2 diabetes the opportunity to discuss erectile dysfunction as part of their annual review. In Type 2 diabetes (adult onset diabetes), the pancreas makes insulin, but it either doesn't produce enough, or the insulin doesn't work properly. ADA Issues New Type 2 Diabetes Treatment Guidelines. If tighter control can be achieved without increased risk, why should we limit it only to a selected population? After several years of preparation, the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) have released new guidelines on the management of hyperglycemia in patients with type 2 diabetes mellitus (T2DM). This amount of data would not have been sufficient by today's standards. For achievement of long-term sustainable results that lead to changes in life expectancy, many of these patients will eventually need to undergo bariatric surgery (61). Given the increased prevalence of type 2 diabetes worldwide, most patients are treated by their primary health care team (PHCT). The guideline suggestion (Fig. Type 2 diabetes is treated: First with weight reduction, a type 2 diabetes diet, and exercise; Diabetes medications (oral or injected) are prescribed when these measures fail to control the elevated blood sugars of type 2 diabetes. Virta is a proven treatment to reverse type 2 diabetes. I.R. Match season is complex—especially this year. Treatment advancement in people with pre-existing type 2 diabetes. Often, two GLAs are not enough to reach a patient's specific glycemic target, at which point a third GLA or switching to a more potent GLA may be considered. This question is for testing whether or not you are a human visitor and to prevent automated spam submissions. You need to eat something sustainable that helps you feel better and still makes you feel happy and fed. Preventing progression to type 2 diabetes. [2015] 120 mg OD Educate re. Management of type 2 diabetes includes: 1. A large proportion of weight gain attributed to the initiation of insulin therapy can be avoided with simple lifestyle reinforcement measurements. We suggest prioritizing glucose-lowering agents (GLAs) according to their effects on the parameters listed above as well as adherence to therapy and cardiovascular (CV) safety. Blood sugar monitoringThese steps will help keep your blood sugar level closer to normal, which can delay or prevent complications. For patients with an HbA1c >7.5% at diagnosis, initial combination therapy should be considered, and for those with symptomatic hyperglycemia or HbA1c >9%, initial (possibly short-term) insulin therapy should be considered. Insulin and SUs, which are considered inexpensive drugs, have been shown to be the second and fourth leading cause of emergency room admissions due to drug side effects among patients >65 years old in the U.S. (47). When discussing GLA efficacy, we cannot avoid referring to the issue of glycemic durability; SUs, specifically when compared with TZDs, have poor durability (36). 1); however, there are many possibilities. When metformin and lifestyle intervention are the only treatments administered, we may strive to normalize blood glucose levels also in patients at high risk for hypoglycemia, without significant increased risk for side effects or cost. The ADA/EASD Position Statement leaves all possibilities open for the discretion of the treating physician. New drugs, although expensive, may reduce the frequency of blood glucose monitoring (48) and might have lower rates of side effects. However, you may need medications to achieve target blood sugar (glucose) levels. ), on health care provider experience, and, often, on trial and error (5). It is difficult for the PHCTs to sort the data by strength of evidence and to judge the data relevance with respect to individual patient within the short time available for each patient in the primary care setting. When considering the relatively low rates of hypoglycemia in the Outcome Reduction with an Initial Glargine Intervention (ORIGIN) study (39) despite excellent control, we might conclude that this difference no longer holds true when referring to the newer basal insulins. 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Evidence Review: Diabetes Medications as Monotherapy or Metformin-Based Combination Therapy for Type 2 Diabetes: A Systematic Review and Meta-analysis (2016) Full text International guidelines are even more limited by regional and racial differences (e.g., α-glucosidase inhibitors are not an option in the ADA/EASD guidelines [1–3], while they are commonly used in some parts of Asia). Clinical trial data are available for the CV safety of insulin (39), pioglitazone (43,44), DPP-4 inhibitors (26–28), GLP-1 RAs (29), and SGLT2 inhibitors (30). American Diabetes Association. There is some evidence that intensive programs of lifestyle interventions targeting patients with impaired fasting blood glucose reduce the incidence of type 2 diabetes. Physical activity. Get the right care for you. Comparative efficacy and safety of antidiabetic drug regimens added to metformin monotherapy in patients with type 2 diabetes: a network meta-analysis. The suggested Israeli guidelines refocus earlier international recommendations from 2012 and 2015, based on emerging data from cardiovascular outcome trials as well as what we believe are important issues for patient care (i.e., durability, hypoglycemia risk, and weight gain). and not due to GLAs. The setting of an HbA1c target is based not only on patient characteristics but also on the GLA used. If other medications become ineffective treatment with … However, at this treatment stage, the achievement of normoglycemia should be considered according to individual patient adherence and the cost of treatment. How should these data affect our guidelines? Available from, Type 2 diabetes in adults: management NICE guidelines [NG28] [Internet], 2015. The Israel National Diabetes Council guidelines for the treatment of type 2 diabetes. For patients with BMI >35 kg/m2, GLP-1 RAs constitute our second-line drug of choice. Weight loss 2. PHCTs therefore are in need of expert guidance! Selection of a second agent should be based on a discussion of benefits, adverse effects, and costs. Remember, it’s a process. At this point in treatment, we must carefully weigh the potential benefit of any treatment against potential harm and adjust the glycemic target accordingly. has served on the advisory board for Novo Nordisk, Eli Lilly, Sanofi, Merck Sharp & Dohme (MSD), Boehringer Ingelheim (BI), Janssen, Novartis, and AstraZeneca; has received grants (paid to institution) as a study physician by AstraZeneca and Bristol-Myers Squibb; has received research grant support through Hadassah Hebrew University Hospital from Novo Nordisk; and has served on the speakers’ bureau for AstraZeneca and Bristol-Myers Squibb, Novo Nordisk, Eli Lilly, Sanofi, Novartis, MSD, and BI. N Engl J Med 2016;374:1321–1331, Victoza significantly reduces the risk of major adverse cardiovascular events in the LEADER trial [article online], 2016. Pioglitazone after ischemic stroke or transient ischemic attack. These Guidelines comprise a suite of Type 2 Diabetes Guidelines developed in 2009 under a funding agreement between the Department of Health and Ageing and the Diabetes Australia Guideline Development Consortium. What is type 2 diabetes? The three groups of GLAs that meet these criteria are dipeptidyl peptidase (DPP)-4 inhibitors, glucagon-like peptide 1 receptor agonists (GLP-1 RAs), and sodium–glucose cotransporter (SGLT) 2 inhibitors. 2020 Nov 17;173(10):813-821. doi: 10.7326/M20-2470. These recommendations are only one element in the complex process of improving the health of America. A systematic review of the literature, Efficacy and safety of saxagliptin in older participants in the SAVOR-TIMI 53 trial, Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes and moderate or severe renal impairment: observations from the SAVOR-TIMI 53 Trial, NN8022-1922 Study Group. We added emphasis on the importance of teamwork and patient empowerment in endorsing lifestyle modifications throughout the course of treatment—as a backbone for all other interventions. We therefore think that while TZDs, GLP-1 RAs, and insulin might be more effective in achieving and maintaining glycemic control than the other GLAs, SUs, DPP-4 inhibitors, and SGLT2 inhibitors may be considered to have similar effects on blood glucose reduction (37), with limited information on durability available thus far. Position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD), Management of hyperglycemia in type 2 diabetes, 2015: a patient-centered approach: update to a position statement of the American Diabetes Association and the European Association for the Study of Diabetes, European Association for the Study of Diabetes, Medical management of hyperglycaemia in type 2 diabetes mellitus: a consensus algorithm for the initiation and adjustment of therapy: a consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes, Practice guidelines and other support for clinical innovation, Individualizing therapies in type 2 diabetes mellitus based on patient characteristics: what we know and what we need to know, Aace/Ace comprehensive diabetes management algorithm 2015, 10-year follow-up of intensive glucose control in type 2 diabetes, Long-term effects of intensive glucose lowering on cardiovascular outcomes, Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes, Glucose control and vascular complications in veterans with type 2 diabetes, Metabolic memory and individual treatment aims in type 2 diabetes--outcome-lessons learned from large clinical trials, Individualizing glycemic targets in type 2 diabetes mellitus: implications of recent clinical trials, The A1C and ABCD of glycaemia management in type 2 diabetes: a physician’s personalized approach, The addition of E (Empowerment and Economics) to the ABCD algorithm in diabetes care, Beyond metformin: safety considerations in the decision-making process for selecting a second medication for type 2 diabetes management: reflections from a diabetes care editors’ expert forum, Survival as a function of HbA(1c) in people with type 2 diabetes: a retrospective cohort study, Personalized management of hyperglycemia in type 2 diabetes: reflections from a Diabetes Care Editors’ Expert Forum, Clinical assessment of individualized glycemic goals in patients with type 2 diabetes: Formulation of an algorithm based on a survey among leading worldwide diabetologists, Cardiovascular outcome studies with novel antidiabetes agents: scientific and operational considerations, Impact of the U.S. Food and Drug Administration cardiovascular assessment requirements on the development of novel antidiabetes drugs, SAVOR-TIMI 53 Steering Committee and Investigators, Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes mellitus, Alogliptin after acute coronary syndrome in patients with type 2 diabetes, Effect of sitagliptin on cardiovascular outcomes in type 2 diabetes, ELIXA Investigators. However, when one looks at the six groups of GLAs according to these parameters as well as CV safety, treatment durability, and compliance, it is striking how different the results are for the different groups of GLAs. For third-line therapy, we also suggest treatment with a GLA that best suits the patient’s medical condition and personal preference. Healthy lifestyle choices — including diet, exercise and weight control — provide the foundation for managing type 2 diabetes. The suggested guidelines state two exceptions where additional therapy should be initiated at the outset: the need for combination therapy or the need for insulin therapy. Shouldn’t the target for a specific patient be driven by the safety of the measures used to achieve this target? The rate of obesity among patients with type 2 diabetes varies in different regions of the world (9); however, it is strongly associated with type 2 diabetes and is often referred to as “diabesity” (41). How can we compare two totally different means of evidence collection? When the sugar can't get where it is supposed to be, it leads to elevated blood sugar levels in the bloodstream, which can lead to complications such as kidney, nerve, and eye damage, and cardiovascular disease. However, clinical guidelines have certain limitations. Available from, Mearns ES, Sobieraj DM, White CM, et.al. A medical guideline (also called a clinical guideline, clinical protocol, or clinical practice guideline) is defined as, “a document with the aim of guiding decisions and criteria regarding diagnosis, management, and treatment in specific areas of healthcare” (4) (italics added). The dispute over the necessity of CV outcome trials is ongoing (23,25), while the amount of data emanating from published trials is immense. Key Recommendations Metformin should be prescribed for patients with type 2 diabetes when pharmacologic therapy is needed to improve glycemic control. When can we declare a certain GLA as ineffective and stop treatment? Metformin should be prescribed for patients with type 2 diabetes when pharmacologic therapy is needed to improve glycemic control. A sulfonylurea, thiazolidinedione, SGLT-2 inhibitor, or DPP-4 inhibitor should be considered when a second oral medication is added to improve glycemic control. Type 2 diabetes involves problems getting enough glucose into the cells. The second exception mentioned in our suggested guidelines is the need to consider immediate, sometimes short-term, insulin treatment for patients with HbA1c >9% or in a symptomatic patient. Although the place of metformin as first line in the treatment of type 2 diabetes is well established, it is important to note that the only CV outcome trial to support its beneficial CV effect was the UKPDS trial (10), where only 342 patients were included in the metformin arm and the number of coronary death events was 16 with metformin compared with 36 in the competing arm. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. Since certain classes of GLAs do not cause weight gain (DPP-4 inhibitors) and may even promote weight loss (metformin, GLP-1 RAs, SGLT2 inhibitors), the use of these GLAs over others that cause weight gain should be encouraged. Third, the amount of data available from clinical trials in general, and CV outcome trials in particular, is increasing rapidly. hypoglycaemia Target HbA 1c ≤ 7% (53 mmol/mol) Targets and treatment should be individualised Target HbA 1c achieved? Some of the most commonly used diabetes guidelines/Position Statements (3,6–8) include lists of treatment options, which allow the treating PHCT and patient to tailor treatment according to the drug properties, therapeutic target, and patient preferences but may leave some PHCTs without sufficient guidance. Often hypoglycemia prevents patients from achieving better glycemic control, has a deleterious effect on quality of life, and is associated with a major economic burden including the need to self-monitor blood glucose levels and days lost at work (40). **Cost is variable, with newer insulin analogues being more expensive. 1) presented here is an updated version of one that was previously published (50) and accepted by the Israel National Diabetes Council, a multidisciplinary team chosen to serve as an advisory board to the Israeli Ministry of Health. The ADA/EASD Position Statement did not list this parameter as a consideration when choosing GLAs, although the approach of the U.S. Food and Drug Administration differs (1,2,24). Primary care physicians will sometimes consider referring patients reaching third-line therapy to a diabetes specialist. The cost of treating patients with diabetes around the world is a major consideration for patients, health care organizations, and governments (9). This type occurs most often in people who are over 40 years old but can occur even in childhood if … Unlike in oncology, personalized medicine in diabetes treatment is based on phenotypic rather than genotypic expression (e.g., patient weight, age, fasting and postprandial glucose levels, etc. Owing to these numbers, most patients with diabetes are and will in the foreseeable future be treated by their respective PHCTs. At the same time, teamwork includes communication and shared responsibilities between the PHCT and the diabetologist/endocrinologist and timely referral of the more difficult-to-manage patients to specialists. Healthy eating 3. Guidance for industry: evaluating cardiovascular risk in new antidiabetic therapies [Internet], 2008. [2015] 1.7.14 Assess, educate and support men with type 2 diabetes who have problematic erectile dysfunction, addressing contributory factors such as cardiovascular disease as well as possible treatment options. EXECUTIVE SUMMARY. Besides HbA1c, as explained above, we choose to use BMI as the basis for recommending a preferred second-line treatment for a specific patient. When cost is a major limiting factor, less preferable GLAs to be consider include pioglitazone, α-glucosidase inhibitors, insulin, and SUs. Some GLAs have a low side effect profile and subsequently high rates of patient adherence to therapy, most notably DPP-4 inhibitors (33), while others do not (e.g., TZDs, SUs, GLP-1 RAs, insulin). Copyright © 2020 American Academy of Family Physicians.  All rights Reserved. The level of evidence required today for the introduction of new GLAs differs from what was required in the past (23), and no such information will be available for some of the older drug groups. The first is setting the HbA1c target as approaching near normoglycemia, with different degrees of stringency according to patient characteristics. Smoking cessation. Prepare for the ABFM exam with the AAFP’s Family Medicine Board Review Express Livestream, February 18-21 and get the same in-depth Board review but with all the conveniences of your home or office. The option of bariatric surgery should be discussed with possible candidates in the early stages of their disease—before they develop micro- and macrovascular complications. We do not capture any email address. In other cases, a combination of medications works better. Teamwork includes a multidisciplinary team of nurses, dietitians, social workers, medical psychologists, and the treating physician. Global guideline for type 2 diabetes [Internet]. While many more data are being collected regarding the newer agents, it has become even harder to compare them with older agents, for which such data are not available. Other considerations. For patients with BMI 30–35 kg/m2, we consider SGLT2 inhibitors and GLP-1 RAs as equally good options, and while compliance might be better with SGLT2 inhibitors, weight loss may be greater with GLP-1 RAs. Individual patient beliefs, preferences, and specific lifestyle circumstances (for example, fear of hypoglycemia, fear of injection, high-risk occupation [drivers], tolerability of gastrointestinal side effects, etc.) Duality of Interest. We support the ADA/EASD Position Statement, which specifically proposes that if a patient has not achieved his or her glycemic target within 3–6 months, treatment should be changed or intensified. Type 2 diabetes most often develops in people over age 45, but more and more children, teens , and young adults are also developing it. First, individualization of the stringency by which glycemic control targets are set (1,16–19) has left many open questions regarding the best glycemic target for a given patient (20–22). More than 34 million Americans have diabetes (about 1 in 10), and approximately 90-95% of them have type 2 diabetes. In conclusion, we present here a suggestion to modify existing guidelines for the treatment of hyperglycemia in patients with type 2 diabetes. Type 2 diabetes, the most common type of diabetes, is a disease that occurs when your blood glucose, also called blood sugar, is too high. Direct comparison of GLP-1 RAs to basal and even short-acting insulin also did not yield significant differences in glycemic control (35). BMI might be the strongest phenotype to follow when considering treatment for patients with diabetes (57). Glucose monitoring. DPP-4 inhibitors might not be preferred in this group of patients owing to the agents’ weight neutrality. Anti-hyperglycemic therapy 3. As with all clinical reference resources, they reflect the best understanding of the science of medicine at the time of publication, but they should be used with the clear understanding that continued research may result in new knowledge and recommendations. While the ADA/EASD Position Statement (1,2) supports a target HbA1c of <7% for most patients, it recommends a more stringent target (HbA1c 6.0–6.5%) for select patients, as long as it can be achieved without increased risk of hypoglycemia or other prominent side effects. The immediate, sometimes very high cost of newer GLAs must be weighed against potential downstream cost spent on treatment of side effects and complications. Considering the fact that diabetes is only one of the countless medical conditions that PHCTs treat, it is challenging to keep up with this mountain of data. Side effects may also partly explain why patients have higher rates of drug discontinuation in “real-world” observational trials compared with clinical trials (46). Intensive programs of lifestyle interventions targeting patients with type 2 diabetes gain but have not been associated with mortality! We use safer drugs, are the increased prevalence of type 2 and... 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