Trying to Live Normally: ADA's 2017 Focus on Whole Patient

Miriam E Tucker

December 16, 2016

The American Diabetes Association's 2017 Standards of Medical Care include a new focus on assessment of the social, psychological, and financial circumstances in patients' lives that affect their ability to self-manage their diabetes, with the emphasis being on helping those with the condition to live as normal lives as possible.

The ADA's annual Standards of Medical Care in Diabetes, published online December 15 in a supplement to Diabetes Care, also address antibody screening of asymptomatic first-degree relatives of patients with type 1 diabetes with the aim of preventing diabetic ketoacidosis (DKA), a new standardized definition for hypoglycemia, use of empagliflozin (Jardiance, Eli Lilly) or liraglutide (Victoza, Novo Nordisk) in patients with type 2 diabetes who have established cardiovascular disease (CVD), and monitoring for metformin-induced vitamin B12 deficiency.

The 142-page document also contains new advice or updates related to gestational diabetes follow-up, inclusion of sleep assessment in diabetes management, use of fat and protein in insulin-dosing calculations, interruption of sitting every 30 minutes with short exercise bouts, and consideration for use of metabolic (formerly bariatric) surgery down to body mass index 30 kg/m2.

"The ADA is the only group that revises practice guidelines annually.…We are very proud that our professional practice committee works as hard as they do to identify new data that have significant impact on patient outcomes and we present that" on a yearly basis, ADA chief scientific and medical officer Robert E Ratner, MD, told Medscape Medical News.

The Whole Patient

For 2017, the ADA advises assessment of nonmedical factors that influence patients' abilities to self-manage their diabetes, including issues around access to care, financial barriers, and food insecurity, along with psychological or psychiatric disorders.

A new chapter called "Promoting Health and Reducing Disparities in Populations" provides guidance for promoting patient-centered care aligned with the Chronic Care Model, team-based care, and referral to local community resources for further support.

"You need to be aware of issues that impact self-management.…It doesn't do the patient or clinician any good if the clinician writes a prescription for an expensive branded medication and the patient can't afford it," Dr Ratner noted.

New recommendations for psychosocial assessment and intervention were published in a separate document November 22 in Diabetes Care.

We're not just managing glucose, we're managing a human being who's trying to live a normal life.

These include evaluation for symptoms of diabetes distress, depression, anxiety, and disordered eating and of cognitive capacities, using appropriate standardized tools at initial visits, periodic intervals, or if the patient experiences any changes that merit concern, with the inclusion of family members when appropriate. Any problems found should be addressed via follow-up visit or referral.

In particular, depression is extremely common in both type 1 and type 2 diabetes and doubles the cost of care if left untreated, Dr Ratner said.

"The idea is that we're not just managing glucose, we're managing a human being who's trying to live a normal life, and it's hard.…Ultimately, the person with diabetes is their own primary caregiver, and we need to be able to support them in doing that very difficult job," he said.

Diagnosing Type 1 Diabetes Earlier

The standards now also recommend that first-degree relatives of people with type 1 diabetes be screened for islet autoantibodies and classified based on a previously described three-stage model.

Those positive for two or more antibodies on two separate occasions have a greater than 95% probability of developing type 1 diabetes and need to be monitored closely.

The evidence for this is included in a paper published December 15 in Diabetes that summarizes findings from a research symposium held in October 2015 entitled, "The Differentiation of Diabetes by Pathophysiology, Natural History, and Prognosis," cosponsored by the ADA, European Association for the Study of Diabetes (EASD), JDRF, and American Association of Clinical Endocrinologists.

"To identify type 1 diabetes even before glucose levels go up is absolutely critical. Far too many individuals present in diabetic ketoacidosis, which is a potentially lethal complication," Dr Ratner said.

"By identifying individuals at the stage of persistent positive antibodies, we have the research opportunity to intervene and prevent the progression, but more important, we know who's at risk and can begin therapy before DKA.…This is a huge and fundamental change in our understanding of T1D."

Defining Hypoglycemia Without Symptoms

Another new recommendation, initially published in a separate position statement on November 21, calls for "serious, clinically significant" hypoglycemia to be officially defined as a value less than 54 mg/dL (< 3.0 mmol/L), with a "glucose-alert value" designating need for action set at 70 mg/dL (3.9 mmol/L) or lower. Symptoms have been removed from the definition.

The recommendation, made in conjunction with the EASD, is aimed at standardizing reported hypoglycemia in studies and for regulatory purposes but has clinical implications as well, Dr Ratner said.

"It recognizes the fact that a lot of people have hypoglycemic unawareness.…If you have a [confirmed] value of 50, that's serious hypoglycemia even without symptoms.…What we're saying is individuals and their caregivers should strive to never have a glucose value less than 54."

The 70-mg/dL value is not considered hypoglycemia but rather a level suggesting that a therapeutic adjustment be made, such as adjusting insulin dose, eating, or suspending the patient's insulin pump.

"Our therapeutics aren't that good, so we need a buffer zone between a potentially dangerous level and where we're going to intervene," Dr Ratner explained.

The Endocrine Society has also just issued a new blueprint that sets out a framework for reducing the incidence of hypoglycemia.

Revisions to Pharmacologic Guidelines

A new separate chapter in the ADA standards is devoted to pharmacologic approaches to glycemic treatment (the previous ADA guidelines had included nonpharmacologic approaches in the same chapter).

In this, a statement has been added that "in patients with long-standing suboptimally controlled type 2 diabetes and established atherosclerotic cardiovascular disease, empagliflozin or liraglutide should be considered, as they have been shown to reduce cardiovascular and all-cause mortality when added to standard care."

Some had expected a stronger recommendation following the results of the EMPA-REG OUTCOME and Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results (LEADER) trials, but the evidence doesn't support use beyond the particular types of patients studied, Dr Ratner stressed.

"EMPA-REG and LEADER were very important studies, and we discuss them extensively and their potential value in patients with underlying CVD, because those were [the patients] studied.…Over half of the patients in both trials were already on insulin. [Empagliflozin and liraglutide] were used very late in the disease. So absolutely consider their use in patients with established CVD, because that's who benefited."

Also included in the pharmacologic chapter is a new evidence-based recommendation to consider periodic measurement of vitamin B12 levels in patients on long-term metformin use and use supplementation as needed, following reports regarding an association between metformin use and vitamin B12 deficiency.

And, in light of the overall emphasis on real-life circumstances, for the first time this year the standards provide median cost information for glucose-lowering medications, including insulins.

Dr Ratner is an ADA employee and has no relevant financial relationships. Disclosures for the practice committee are listed in the standards.

Diabetes Care. Published online December 15, 2016. Standards of Care

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