New type 2 diabetes guidelines from the American College of Physicians (ACP) recommend less-intensive blood sugar control for most patients, with a glycated hemoglobin (HbA1c) target between 7% and 8%.
“Studies have not consistently shown that intensive glycemic control to HbA1c levels below 7% reduces clinical microvascular events, such as loss or impairment of vision, end-stage renal disease, or painful neuropathy, or reduces macrovascular events and death,” said first author Amir Qaseem, MD, PhD, ACP vice president for clinical policy, and colleagues.
To develop the new recommendations, the authors evaluated six sets of current guidelines from other organizations and reviewed five important clinical trials on which those guidelines are based. The updated guidance, published online in Annals of Internal Medicine, offers four key statements:
- Statement 1: Clinicians should personalize goals for glycemic control in patients with type 2 diabetes on the basis of a discussion of the benefits and harms of pharmacotherapy, patients’
- preferences, patients’ general health and life expectancy, treatment burden, and costs of care
- Statement 2: Clinicians should aim to achieve an HbA1c level between 7% and 8% in most patients with type 2 diabetes
- Statement 3: Clinicians should consider de-intensifying pharmacologic therapy in patients with type 2 diabetes who achieve HbA1c levels less than 6.5%
- Statement 4: Clinicians should treat patients with type 2 diabetes to minimize symptoms related to hyperglycemia and avoid targeting an HbA1c level in patients with a life expectancy less than 10 years due to advanced age (80 years or older), residence in a nursing home, or chronic conditions (such as dementia, cancer, end-stage kidney disease, or severe chronic obstructive pulmonary disease or congestive heart failure) because the harms outweigh the benefits in this population
Qaseem et al reviewed and scored currently available guidelines using the AGREE II (Appraisal of Guidelines for Research and Evaluation II) instrument. This tool asks 23 questions about central aspects of recommendations, including their scope and purpose, stakeholder involvement, rigor of development, clarity of presentation, applicability, and editorial independence. The authors scored each guideline independently, and then compared the scores.
The two lowest-scoring guidelines were from the American Association of Clinical Endocrinologists/American College of Endocrinology (AACE/ACE) and the American Diabetes Association (ADA). Both scored lowest on stakeholder involvement, applicability, editorial independence, and scientific rigor.
“Several factors were important in considering guideline quality,” the authors said. “For example, although many guidelines described benefits, adverse effects, and the strength and limitations of evidence or linked the evidence to the recommendation, they often inadequately described how they had considered or weighted these factors in developing the final recommendations. The guidelines frequently relied on selective reporting of studies or outcomes and focused on relative versus absolute effects and asymptomatic surrogate measures rather than patient-centered health outcomes.”
The five clinical trials reviewed were:
- ACCORD (Action to Control Cardiovascular Risk in Diabetes)
- ADVANCE (Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation)
- VADT (Veterans Affairs Diabetes Trial)
- Both UKPDS (United Kingdom Prospective Diabetes Study) trials
“Collectively, these trials showed that treating to targets of 7% or less compared with targets around 8% did not reduce death or macrovascular events over about 5 to 10 years of treatment but did result in substantial harms, including but not limited to hypoglycemia,” the authors wrote. “No trials show that targeting HbA1c levels below 6.5% in diabetic patients improves clinical outcomes, and pharmacologic treatment to below this target has substantial harms.”
The ACP recommendation to de-escalate therapy in patients who achieve HbA1c levels less than 6.5% is notably different from other guidelines, said David Lam, MD, of Icahn School of Medicine at Mount Sinai in New York City, in a statement. “This may change how some providers care for patients who are able to achieve this level of control. However, it is important to also consider what potential impact the subsequent increase in HbA1C level may have on the patient’s quality of life and their perception of overall health.”
The recommendation against a specific HbA1C target in patients with limited life expectancy and multiple comorbidities is another difference, he continued. “While many providers likely already adjust their A1C goals in this subset of patients, this guideline may further change the care in this group of patients.”
Qaseem and co-authors concluded: “The ACP believes that clinicians should reevaluate HbA1c levels and revise treatment strategies on the basis of changes in the balance of benefits and harms due to changed costs of care and patient preferences, general health, and life expectancy.”
Click here for the AACE/ACE Clinical Practice Guidelines for Developing a Diabetes Mellitus Comprehensive Care Plan – 2015.
The guidelines were funded by the American College of Physicians.
Qaseem reported having no financial conflicts of interest.