ACP Calls for Moderate Glycemic Control in Type 2 Diabetes

March 09, 2018, 08:39 am Chris Crawford – On March 6, the American College of Physicians (ACP) published new evidence-based guidance statements in Annals of Internal Medicine that focus on loosening glycemic control targets.

AAFP’s Stance

According to Jennifer Frost, M.D., medical director for the AAFP Health of the Public and Science Division, the Academy has endorsed a 2016 ACP clinical practice guideline on oral pharmacologic treatment of type 2 diabetes mellitus that emphasized “individualized assessment of risk for complications from diabetes, comorbidity, life expectancy and patient preferences.”

That guideline said, “An HbA1c level less than 7 percent based on individualized assessment is a reasonable goal for many but not all patients.”

“The AAFP strongly supports individualized treatment and shared decision-making based on a balance of potential benefits and harms,” Frost told AAFP News.  “Rather than targeting a specific number, family physicians should consider patients’ goals and preferences along with their comorbidities. Treatment of diabetes, or any chronic illness, is not ‘one size fits all.'”

It also should be noted that representatives from the American Diabetes Association (ADA) and American Association of Clinical Endocrinologists (AACE) have said they do not agree with the higher glycemic control targets outlined in the newly released ACP guidance statements.

Guidance Statements

The ACP released the following four guidance statements on selecting appropriate targets for pharmacologic treatment of type 2 diabetes:

Guidance Statement 1: Clinicians should personalize goals for glycemic control in patients with type 2 diabetes based on a discussion of benefits and harms of pharmacotherapy, patients’ preferences, patients’ general health and life expectancy, treatment burden, and costs of care.

Guidance Statement 2: Clinicians should aim to achieve an HbA1c level between 7 percent and 8 percent in most patients with type 2 diabetes.

Guidance Statement 3: Clinicians should consider deintensifying pharmacologic therapy in patients with type 2 diabetes who achieve HbA1c levels less than 6.5 percent.

Guidance 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 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.

Evidence Reviewed

The ACP explained that its guidance statements were based on a review and methodological critique of existing and sometimes conflicting guidelines rather than a systematic review of all available evidence.

The group reviewed and rated six guidelines, focusing specifically on sections that addressed HbA1c in nonpregnant patients with type 2 diabetes. They included four commonly used guidelines from the AACE and American College of Endocrinology, the ADA, the Scottish Intercollegiate Guidelines Network, and the U.S. Department of Veterans Affairs and Department of Defense. The AGREE II (Appraisal of Guidelines for Research and Evaluation II) instrument was used to evaluate the guidelines.

In performing that review, the ACP found five large, long-term randomized controlled trials that investigated intensive (achieved HbA1c levels of 6.3 percent to 7.4 percent) versus less intensive (achieved HbA1c levels of 7.3 percent to 8.4 percent) treatment target strategies in adults, with average baseline ages between 53 and 66.

“They found that the main effect of more intensive glycemic control is small absolute reductions in risk for microvascular surrogate events, such as retinopathy detected on ophthalmologic screening or nephropathy defined by development or progression of albuminuria,” the guideline said.

Studies haven’t consistently shown, however, that intensive glycemic control to HbA1c levels below 7 percent reduced clinical microvascular events — such as loss or impairment of vision, end-stage renal disease, or painful neuropathy — or reduced macrovascular events and death.

“No trials show that targeting HbA1c levels below 6.5 percent in diabetic patients improves clinical outcomes, and pharmacologic treatment to below this target has substantial harms,” the statement said.

For example, the ACCORD trial, which targeted an HbA1c level less than 6.5 percent and achieved the lowest level of the included studies (6.4 percent), was discontinued early because of increased overall and cardiovascular-related death and severe hypoglycemic events.

“Results from studies included in all the guidelines demonstrate that health outcomes are not improved by treating to A1c levels below 6.5 percent,” Ende said in the news release. “However, reducing drug interventions for patients with A1c levels persistently below 6.5 percent will reduce unnecessary medication harms, burdens and costs without negatively impacting the risk of death, heart attacks, strokes, kidney failure, amputations, visual impairment or painful neuropathy.”

Family Physician Expert’s Perspective

John Boltri, M. D., of Rootstown, Ohio, represents the AAFP on the NIH’s National Diabetes Education Program. He told AAFP News that family physicians should use a patient-centered approach with patients who have type 2 diabetes when discussing the risks and benefits of HbA1c at different target levels.

Until now, said Boltri, most family physicians usually have set a target HbA1c at 7 percent, unless patients are older and their life expectancy is shorter. The new ACP guidance statements might allow family physicians to relax their goals, especially in patients for whom achieving 7 percent isn’t a reasonable goal, he noted.

“If a patient with type 2 diabetes’ A1c is starting out at 8 or 7.5 percent, less than 7 percent might be a good target,” Boltri explained. “If A1c is starting at 13 percent, getting to less than 7 percent is probably unreasonable; shooting for 7 percent to 8 percent is probably a lot more reasonable in those patients.”

Practicing family physicians also should consider factors such as patients’ goals, life expectancy and ability to tolerate medications in these discussions, Boltri said.

It’s also important to remember that there are many other factors that lead to morbidity in patients with diabetes, such as cardiovascular disease, being sedentary, hyperlipidemia and obesity, he added.

“So, a singular focus on a hemoglobin A1c without looking at the big picture is less beneficial to patients,” Boltri stated.

As for the guidance statement on deintensifying pharmacologic therapy if patients have HbA1c levels below 6.5 percent, Boltri agreed that aggressive control to less than 6.5 percent may increase mortality, and consideration should be given to mitigating those risks.

However, he added, “If I have a patient at 7.1 percent and they can get down to 6.4 percent with diet and lifestyle changes alone, I’m not going to back off on their treatment plan. So, this shouldn’t be a universal ‘We have them at 6.3 percent, so we need to get them back up to 7 percent.’

“On the other hand, if you’re having to use three drugs to get them to 6.3 percent and they are experiencing adverse effects, it might be safer for your patient to back off therapy. “

More From AAFP
American Family Physician: AFP by Topic: Diabetes: Type 2

Familydoctor.org: Diabetes

Type 2 Diabetes Mellitus: ACP Releases Updated Guidance Statement on A1C Targets for Pharmacologic Glycemic Control

LISA CROKE, AFP Senior Associate Editor

Am Fam Physician. 2018;98(9):613-614

Author disclosure: No relevant financial affiliations.

Key Points for Practice

• Goals of glycemic control should be individualized to each patient, after discussing harms and benefits, preferences, overall health status, treatment burden, and expense.

• An A1C target of 7% to 8% is recommended for most patients, because targets of 7% or less do not appear to result in reduced risk of mortality or macrovascular events.

• The medication regimen may be de-escalated in patients with an A1C level less than 6.5%, because there is no evidence of clinical benefit in patients at this level.

From the AFP Editors

More than 9% of persons in the United States have type 2 diabetes mellitus. Increased blood glucose levels in these patients can lead to polyuria, polydipsia, weight loss, and dehydration. Although lowering blood glucose levels can decrease the risk of these symptoms and the associated complications, there are still disadvantages to doing so, including adverse effects, increased treatment burden, and expense.

A1C measurement is one method for determining blood glucose levels, but it is inconsistent and can change based on a patient’s race and ethnicity. Previous guidelines have recommended the use of medications to reach A1C targets; however, an ideal target remains debatable. This guidance statement from the American College of Physicians (ACP) aims to help physicians achieve appropriate A1C targets via medication for nonpregnant patients with type 2 diabetes based on a review of six health care organization guidelines. In a review of these guidelines, the authors found no studies indicating that A1C targets less than 6.5% improve clinical outcomes. Moreover, using medication to achieve this level had associated harms.

Guidance Statements

Goals of glycemic control via medication should be individualized to each patient, after talking about benefits and harms of more vs. less control, preferences, overall health status, treatment burden, and expense. Because targets of 7% or less vs. approximately 8% do not appear to result in reduced risk of mortality or macrovascular events, an A1C target of 7% to 8% is recommended for most patients. However, variability in A1C measurements should still be considered when making treatment decisions. Taking into account patient preference, a stricter A1C target can be considered in persons who are expected to live at least 15 more years. A lower target can be considered in patients who can achieve it with diet and lifestyle changes.

Because there is no evidence that an A1C level lower than 6.5% has clinical benefit, and evidence has shown associated harms, the medication regimen may be de-escalated (i.e., reduce dosage or decrease the number of medications prescribed) in patients who achieve an A1C level lower than 6.5%. Treatment in older persons and those with a shorter life expectancy should aim to reduce symptoms of hyperglycemia, rather than to achieve A1C targets. In addition, because achieving certain A1C targets is associated with more harm than good, these targets are not recommended in any patient expected to live fewer than 10 years because of older age (80 years and older), living in a long-term care facility, or with a chronic condition.

Other Considerations

All patients with type 2 diabetes should be supported in making healthy lifestyle choices, such as quitting smoking and achieving a healthy body weight. When making treatment decisions, individual patient factors, such as comorbid conditions, and patient preference should be taken into account. Because of the variability in A1C measurements, when selecting an A1C target, a range should be identified, rather than a single number.

Guideline source: American College of Physicians

Evidence rating system used? No

Systematic literature search described? Yes

Guideline developed by participants without relevant financial ties to industry? No

Recommendations based on patient-oriented outcomes? Yes

Published source:Ann Intern Med. April 17, 2018;168(8):569–576

Available at:http://annals.org/aim/fullarticle/2674121/hemoglobin-1c-targets-glycemic-control-pharmacologic-therapy-nonpregnant-adults-type

Editor’s Note: The “lower is better” drumbeat in the type 2 diabetes treatment community for almost 50 years is starting to fade away as the lack of benefit—and increased risk of harm—has been demonstrated in several studies. Although some endocrine societies are still holding out for lower A1C targets, the American Diabetes Association also has come to recognize the need to consider many factors other than glycemic control when making decisions about treatment goals. Shared decision making, based on a shared understanding of the possible risks and benefits of specific goals, should replace strict A1C targets.—Allen F. Shaughnessy, PharmD, AFP Assistant Medical Editor

What you need to know about diabetes

Diet
Diabetes
Endocrinology

Diabetes mellitus (DM) is one of the most common diseases on the planet, and is truly a non-communicable epidemic. To date, there are 463 million patients with diabetes in the world, which is about 6% of the total population of the globe, and the incidence is steadily increasing. In Russia, 4.5 million people suffer from DM. Every year, 200,000 people die from diabetes and its complications in Russia.

Diabetes mellitus is a chronic disease characterized by an increase in blood glucose and is accompanied by damage and dysfunction of various organs, especially the eyes, kidneys, heart, blood vessels and nerves.

To maintain life, our body needs a constant supply of energy. Glucose is the main, simplest and most accessible energy substrate. Glucose is the end product of the breakdown of carbohydrates found in bread, cereals, potatoes, and even milk, and enters the bloodstream from the digestive tract. Further, glucose must enter the cells through special “channels”, and here the hormone insulin is needed, without it these “channels” will not open. Glucose penetrates into some tissues (nervous tissue, erythrocytes, eye tissues, etc.) without the participation of insulin, therefore, with a high level in the blood, there is an increased intake, accumulation and damaging effect.

Insulin is synthesized by endocrine cells (beta cells), which are located in the pancreas in the form of clusters (islands). They constantly, throughout their lives, produce the necessary amount of insulin so that glucose from the blood can enter the cells and provide them with the necessary energy. Due to this, in a healthy person during the day, blood glucose ranges from 3.3 to 7.8 mmol / l. On an empty stomach, it usually ranges from 3.3 to 5.8 mmol / l, and 2 hours after a meal – from 3.3 to 7.8 mmol / l.

Diagnosis criteria for diabetes mellitus are established by the World Health Organization (WHO). They are the SAME for people of ALL ages and are: 7 or more mmol / l on an empty stomach and 11 or more mmol / l 2 hours after a food load (or glucose load when conducting a special test). Blood glucose levels that fall in the range between normal and diabetic are referred to as prediabetes. The blood glucose levels for diagnosing diabetes mellitus associated with pregnancy are somewhat different. This is gestational diabetes that occurs during pregnancy and resolves after childbirth.

In the complete absence of insulin, which is associated with the destruction of pancreatic islets, glucose cannot pass through the cell membrane into the cytoplasm and accumulates in large quantities in the blood. This situation is typical for type 1 diabetes. This type often develops in children, adolescents and young people, although it sometimes occurs after 40 years.

Diabetes mellitus type 1 is characterized by an acute onset and severe complaints: a person develops frequent profuse urination, thirst, dry mouth, weakness, weight loss. In the absence of timely assistance, severe metabolic complications that threaten life quickly set in. In this case, only one treatment is possible – insulin therapy.
The proportion of type 1 diabetes is about 10%. The remaining 90% in the incidence structure is occupied by type 2 diabetes mellitus.

In type 2 diabetes, the mechanism for increasing blood sugar is different. Beta cells produce insulin, but this insulin cannot adequately perform its function due to impaired susceptibility of the body to it. As a result, in the presence of insulin (often even an excess amount), glucose cannot enter the cells and remains elevated in the blood. This condition is called insulin resistance (insulin insensitivity) and in order to overcome this, beta cells must produce more insulin.

Type 2 diabetes develops gradually. Such characteristic symptoms as dry mouth, thirst, frequent urination, nocturia (nighttime urination), itchy skin may be subtle and go unnoticed. In this regard, despite all the achievements of modern medicine, type 2 diabetes mellitus is very often not detected in a timely manner, and at the time of diagnosis, the patient has complications, such as damage to the eyes, kidneys, lower extremities, and cardiovascular diseases.

Every modern person can and should be aware of the risk factors for developing type 2 diabetes, which can be divided into two groups. The first group is non-modifiable risk factors, that is, those that we cannot influence in any way. These are age, heredity, the presence of certain diseases, including endocrine ones. The second group is modifiable risk factors. These are the factors, the change of which is in our hands, which we must eliminate or at least reduce. These include, first of all, OVERWEIGHT, improper unbalanced nutrition, low physical activity.

People with risk factors should have their blood glucose checked regularly. To do this, you can use a glucometer (a portable device for rapid analysis) or once every three to six months to control the level of blood glucose in the laboratory. Particularly informative is the definition of such an indicator as glycated (glycosylated) hemoglobin (HbA1C), which allows you to judge the average damage to glycemia over the previous 3 months.

If even minor deviations are found in the analyzes, it is necessary to contact an endocrinologist. Only a specialist, having carried out all the necessary tests and analyzes, will be able to identify the onset of diabetes mellitus, as well as hidden disorders of carbohydrate metabolism.

Early detection of both diabetes and pre-diabetes will allow you to start a timely fight against the disease and help prevent the development of complications. Prolonged lack of treatment leads to irreversible consequences for the whole organism. Therefore, timely diagnosis and the appointment of adequate individually selected therapy is vital.

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Author of article

Elizaveta Chihun
Vladimirovna

Endocrinologist

Work experience: since 1999

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Diabetes mellitus type 2. Answers to the main questions from the endocrinologists of the Ilyinsky hospital.

Type 2 diabetes most
a common form of diabetes mellitus – both throughout the world and in our country.

It used to be called “diabetes of the elderly”, “diabetes of the obese”,
“insulin independent”. In typical cases, he
develops against the background of excess weight, and usually – over the age of 40 years (although
in recent years, its prevalence has been increasing in younger people
age and even children). The disease occurs because, against the background of excessive
cells of the body become insensitive to the action of insulin
(which “sends” nutrients to the cells after eating). As a result
these nutrients (primarily glucose) in too much
quantities remain in the blood, and this has a damaging effect on the body.

Type 2 diabetes is treated with a diet
weight loss and antidiabetic drugs in tablets (which are currently
day there are 7 different classes). But approximately 20-30% of patients require
the use of insulin (therefore, from the name “insulin-independent” to denote
This form of diabetes was decided to be abandoned). Moreover, in the last 10 years,
practice also included non-insulin injectables.

There are some wrong approaches to the treatment of diabetes,
due to which the disease can manifest its cunning in the form of secretive development
complications. Let’s discuss some of them.

• I was diagnosed
  “diabetes” but I don’t feel any signs of high sugar, oh
  which are usually written. Does this mean I don’t have diabetes? I just have a little
  increased sugar?

Diagnosis of diabetes mellitus is based on
stable excess of blood sugar over a certain limit (for glucose
blood on an empty stomach “diabetic” level – above 7 mmol / l). At the same time, approximately
half of people with type 2 diabetes have no symptoms of high
Sahara. Unfortunately, this does not change the diagnosis of diabetes, because the damaging
The effect of sugar on the body depends on its level, and not on the presence of symptoms.

Again – in order to prevent complications. Before
the second half of the 1990s, they thought that the main thing in diabetes is to prevent
diabetic coma and remove the unpleasant symptoms of high sugar. But then
Numerous long-term studies have shown that
that the closer to normal sugar becomes during treatment, the slower
complications of diabetes develop.

• I had sugar
  type 2 diabetes, but then I was put on insulin. Now I have type 1 diabetes?

No. The type of disease is determined by the mechanism of its development, and
not what treatment is used. Yes, some patients with type 2 diabetes need insulin injections to normalize blood sugar, but type 2 diabetes
this does not change. In this situation, we speak of “type 2 diabetes,
insulin-requiring.”

Required. The fact is that the ability of your pancreas to secrete insulin in diabetes is depleted over the years. Therefore, over time, the effect of hypoglycemic drugs weakens, and therapy has to be intensified. Proper nutrition (especially if it is aimed at losing weight) is the best way to prolong the life of pancreatic cells that secrete insulin. In this case, sugar will be at a good level not only today, but also in many years to come.

• I bought tablets from
  diabetes, and sugar became normal. Why should I go to the doctor?

Doctor’s tasks in the outpatient care of a patient with diabetes
consist not only in the appointment of hypoglycemic drugs, but also in regular
monitoring the result of their action, as well as in periodic (usually annual)
screening to detect complications of diabetes in the early stages. In particular,
to make sure that hypoglycemic drugs are doing their job,
it is necessary to measure not only the level of sugar (which is usually controlled
before meals, when this indicator decreases). A very important parameter is the level
glycated hemoglobin (HbA1c). Only if this
the indicator is in the so-called target range (in fact, slightly
different from the norm), we can say that the treatment is chosen correctly. IN
in general, monitoring the health status and effectiveness of therapy in diabetes –
It’s a complicated process and you can’t manage everything on your own.

• Treatment
  diabetes mellitus in the Ilinskaya hospital ?

Type 2 diabetes mellitus is treated in the Ilyinskaya hospital by experienced endocrinologists who strictly follow modern international
recommendations. When necessary, we use portable devices for
continuous blood glucose monitoring and insulin pumps,
self-injecting insulin (including pumps with feedback, automatically
corrective drug delivery). Of particular importance are special professional
the skills of our endocrinologists are the ability to motivate the patient, to form
correct attitude towards one’s chronic disease, to educate the patient sometimes
rather complicated but necessary steps in order to keep diabetes in
subordination. Regular outpatient follow-up of patients reveals
fluctuations in sugar levels, which are often not recorded by a glucometer at home
conditions, notice and stop the developing complications of diabetes in time, and
also change the drug in time if it loses its
efficiency.

Diabetes is insidious
a disease capable of “hidden harm”. Constant surveillance
highly qualified doctors, regular laboratory control, application
the most modern drugs and treatments – all this allows you to keep
diabetes under control and avoid its dangerous consequences.

BagelEvgeniyaViktorovna


Endocrinologist

Candidate of Medical Sciences.

ZilovAlexeyVadimovich


Endocrinologist

Candidate of Medical Sciences.