American College of Physicians: Internal Medicine — Doctors for Adults ®

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ACP DiabetesMonthly



In the News for the month of October 2012




Highlights

Screening for diabetes may not reduce mortality

One round of screening for type 2 diabetes in high-risk patients was not associated with a reduction in all-cause, cardiovascular, or diabetes-related mortality within 10 years, researchers in the U.K. reported. More...

Task force releases new standards for diabetes self-management education, support

A task force from the American Diabetes Association (ADA) and American Association of Diabetes Educators (AADE) has released new standards for diabetes self-management education and support. More...

Physician empathy associated with outcomes for diabetes patients

Diabetes patients who have highly empathic primary care doctors have better clinical outcomes than those whose doctors are less empathic, a new study found. More...


Test yourself

MKSAP Quiz: inpatient glycemic control

This month's quiz asks readers to evaluate a 78-year-old man with poor glycemic control admitted for femoral-popliteal bypass surgery. More...


From ACP InternistWeekly

EHRs may improve diabetes management and achievement of treatment goals, particularly among those with worst disease control

Use of a commercially available electronic health record (EHR) was associated with improved care processes and better achievement of intermediate treatment outcomes for outpatients with diabetes, a study found. More...


From ACP HospitalistWeekly

Moderate or severe hypoglycemia associated with mortality risk in the ICU

Moderate or severe hypoglycemia in the intensive care unit (ICU) was significantly associated with mortality, according to a new analysis of the NICE-SUGAR trial. More...


From ACP Journal Club

Telemonitoring was associated with greater mortality and did not reduce hospitalizations or ED visits in high-risk elderly patients

A trial in four Minnesota primary care clinics randomized high-risk elderly patients to home telemonitoring or usual care. More...

Neither n-3 fatty acid supplements nor glargine reduced CV events in patients with dysglycemia

The Outcome Reduction with an Initial Glargine Intervention trial randomized about 12,000 patients with cardiovascular risk factors and dysglycemia to basal insulin glargine or usual care and daily n-3 fatty acid supplementation or olive oil placebo. More...


Tool of the month

Admitting a patient with diabetes to the hospital

Persons with diabetes have a two- to four-fold higher hospitalization rate than do those without diabetes. Pre-established goals and a good admission history can improve their care. More...


FDA update

Another weight loss drug approved

A combination of phentermine and topiramate extended-release (Qsymia) was recently approved by the FDA as an addition to a reduced-calorie diet and exercise for chronic weight management. More...


Keeping tabs

Spotlight on the state of diabetes

From the ancient Egyptians to current pilot projects, two recent articles in the New England Journal of Medicine reviewed the history and current state of diabetes care. More...


Education

Global diabetes summit to be held

The 2012 Global Diabetes Summit will be held Nov. 14-17, 2012, in Columbus, Ohio. More...


Physician editor: David V. O'Dell, MD, FACP



Highlights


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Screening for diabetes may not reduce mortality

One round of screening for type 2 diabetes in high-risk patients was not associated with a reduction in all-cause, cardiovascular, or diabetes-related mortality within 10 years, researchers in the U.K. reported.

Researchers conducted a pragmatic parallel group, cluster-randomized trial that recruited more than 20,000 people age 40 to 69 on the basis of a previously validated risk score from among 33 general practices in England. Practices were randomly assigned to three groups: 15 practices conducting screening followed by intensive treatment for diabetics, 13 practices conducting screening plus routine care of diabetes according to national guidelines, and five practices that did not screen and acted as a control group.

Results appeared Oct. 4 in The Lancet.

During more than 184,000 person-years of follow-up, there were 1,532 deaths in the screening practices and 377 in control practices (mortality hazard ratio [HR], 1.06; 95% CI, 0.90 to 1.25). Results were analyzed by intention-to-screen (73% of screening group were screened). There was no significant reduction in mortality from cardiovascular causes (HR, 1.02; 95% CI, 0.75 to 1.38), cancer (HR, 1.08; 95% CI, 0.90 to 1.30), or diabetes (HR, 1.26, 95% CI, 0.75 to 2.10) associated with invitation to screening.

The benefits of screening were smaller than found in modeling studies. The authors noted, however, that the mortality rates found in their study were also lower than expected. They concluded that screening might be beneficial only to individuals with detectable disease, rather than the population as a whole.

"If population-based screening for diabetes is to be implemented, it should be undertaken alongside assessment and management of risk factors for diabetes and cardiovascular disease and population level preventive strategies targeting underlying determinants of these diseases," researchers wrote.


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Task force releases new standards for diabetes self-management education, support

A task force from the American Diabetes Association (ADA) and American Association of Diabetes Educators (AADE) has released new standards for diabetes self-management education and support.

The standards are reviewed and revised roughly every five years by experts and stakeholders in the diabetes education community. The revised standards specify the following:

  • Clinicians who provide diabetes self-management education (DSME) will document an organizational structure, mission statement and goals. They will also seek ongoing input from stakeholders and experts to enhance program quality, and identify resources that can help support people with diabetes.
  • A coordinator will oversee the DSME and be responsible for planning, implementing and evaluating education services. One or more instructors will provide DSME—and diabetes self-management support (DSMS) when applicable—and at least one will be a registered nurse, dietitian or pharmacist with training and experience relevant to DSME, or have relevant certification.
  • After the participant is assessed, he or she will work with the instructor to develop an individualized plan for behavior change and a follow-up plan for ongoing self-management support, both of which will be communicated to other members of the health care team.
  • The framework for providing DSME will be a written curriculum that reflects current evidence and practice guidelines. DSME and DSMS clinicians will monitor goals and outcomes in order to evaluate program effectiveness, and look for ways to improve quality.

The task force emphasized the importance of regular communication among health care team members and of putting the individual with diabetes first. "It is the individuals with diabetes who do the hard work of managing their condition, day in and day out. The educator's role, first and foremost, is to make that work easier," they wrote.


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Physician empathy associated with outcomes for diabetes patients

Diabetes patients who have highly empathic primary care doctors have better clinical outcomes than those whose doctors are less empathic, a new study found.

Researchers retrospectively examined 2009 data from 20,961 type 1 or type 2 diabetes patients in Parma, Italy. These patients were enrolled with one of 242 primary care physicians, all of whom completed a Jefferson Scale of Empathy test. The physicians' scores were compared with their patients' occurrence of acute metabolic complications, including hyperosmolar state, diabetic ketoacidosis and coma, as identified by ICD-9-CM codes. Results were published in the September 2012 Academic Medicine.

Patients of physicians with high empathy scores had a significantly lower rate of acute metabolic complications (4.0 per 1,000 patients) than patients of doctors with low empathy scores (6.5 per 1,000 patients; P<0.05) and moderate empathy scores (7.1 per 1,000 patients; P<0.01). There was no significant difference in complication rate between patients of doctors with low and moderate empathy scores. Doctors with low empathy scores were associated with acute metabolic complications in logistic regression analysis compared to high-scoring physicians (odds ratio [OR], 0.59; 95% CI, 0.37 to 0.95). Older patients (at least 69 years old) were also more likely to have acute metabolic complications (OR, 1.7; 95% CI, 1.2 to 2.4). Factors that weren't associated with acute metabolic complications included physicians' gender and age, patients' gender, physicians' type of practice (solo or group), physicians' geographical location of practice, and the length of time a patient had been enrolled with a physician.

Patients whose physicians are more empathic may trust their doctors more, and thus may be more likely to communicate and comply with treatment plans, which could affect outcomes, the researchers noted. The study was limited by its correlational design, which prohibits making cause-effect assumptions, they wrote. Also, there were many potentially confounding variables for which the researchers were unable to control, they added. Still, the findings suggest empathy is an important part of patient care and physician competence that should receive more attention in medical education, they concluded.



Test yourself


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MKSAP Quiz: inpatient glycemic control

A 78-year-old man is evaluated in the hospital for poor glycemic control before undergoing femoral-popliteal bypass surgery. He has been on the vascular surgery ward for 3 weeks with a nonhealing foot ulcer.

mksap.jpg

The patient has an extensive history of arteriosclerotic cardiovascular disease, including peripheral vascular disease, and a 20-year history of type 2 diabetes mellitus. His most recent hemoglobin A1c value, obtained 2 months before admission, was 8.9%. His diabetes regimen consists of glipizide, 40 mg/d. During his hospitalization, his plasma glucose levels have generally been in the 200 to 250 mg/dL (11.1 to 13.9 mmol/L) range. He is eating well.

In addition to stopping glipizide, which of the following is the most appropriate treatment for this patient?

A. Basal insulin and rapid-acting insulin before meals
B. Insulin infusion
C. Neutral protamine Hagedorn (NPH) insulin twice daily
D. Sliding scale regular insulin

Click here or scroll to the bottom of the page for the answer and critique.


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From ACP InternistWeekly


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EHRs may improve diabetes management and achievement of treatment goals, particularly among those with worst disease control

Use of a commercially available electronic health record (EHR) was associated with improved care processes and better achievement of intermediate treatment outcomes for outpatients with diabetes, a study found.

annals.jpg

To examine the association between the EHR and disease control in diabetics, researchers looked at diabetes management and treatment outcomes sequentially across 17 medical centers from 2004 to 2009, adjusting for variables including patient characteristics, medical center, time trends and facility-level clustering. The staggered start of the EHR across the health system allowed the researchers to compare care before the EHR (control group) and after implementation.

Data were derived from a commercially available, certified EHR in place at Kaiser Permanente Northern California, an integrated delivery system that included nearly 170,000 patients with diabetes.

Results appeared in the Oct. 2 Annals of Internal Medicine.

Use of an EHR was associated with:

  • clear improvement in treatment intensification with a trend toward statistical significance at hemoglobin A1c (HbA1c) values of 9% or greater (odds ratio [OR], 1.10; 95% CI, 1.05 to 1.15) or low-density lipoprotein (LDL) cholesterol values of 100 to 129 mg/dL (OR, 1.06; 95% CI, 1.00 to 1.12);
  • increases in 1-year retesting for HbA1c and LDL cholesterol levels among all patients, with the most dramatic change among patients with the worst disease control (HbA1c levels ≥9% or LDL cholesterol levels 130 mg/dL); and
  • decreased 90-day retesting among patients with HbA1c levels less than 7% or LDL cholesterol levels less than 100 mg/dL.

EHR use was also associated with statistically significant reductions in HbA1c and LDL cholesterol levels, with the largest reductions among patients with the worst control (2.19-mg/dL reduction among patients with baseline LDL cholesterol levels ≥130 mg/dL; P<0.001).

Researchers concluded that use of the EHR was associated with improved drug treatment intensification, monitoring and physiologic control among patients with diabetes, with greater improvements among patients with worse control and less testing in patients already meeting guideline-recommended glycemic and lipid targets.

"Our findings, which are consistent across many steps in the care pathway and are proportional to clinical risk levels, suggest actual improvements in the clinical care of patients with diabetes," the researchers wrote. "These early effects on linked care processes and patient outcomes also suggest the potential for future downstream improvements in major clinical event rates and health. The lack of any measurable unintended harm in the outcomes for this study is also important because implementation of an EHR could worsen as well as improve care."



From ACP HospitalistWeekly


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Moderate or severe hypoglycemia associated with mortality risk in the ICU

Moderate or severe hypoglycemia in the intensive care unit (ICU) was significantly associated with mortality, according to a new analysis of the NICE-SUGAR trial.

The Normoglycemia in Intensive Care Evaluation-Survival Using Glucose Algorithm Regulation (NICE-SUGAR) trial randomly assigned intensive care patients to either intensive (mean blood glucose level, 115 mg/dL) or conventional (mean blood glucose level, 144 mg/dL) blood glucose control, and results were published in 2009. This new analysis provides more detail on the associations between intensive control and hypoglycemia and mortality found in the original study. The analysis appeared in the Sept. 20 New England Journal of Medicine.

Of the about 6,000 patients studied, 45% had moderate hypoglycemia, defined as a blood glucose level 41 to 70 mg/dL; 82% of them were in the intensive control group. Severe hypoglycemia (blood glucose level ≤40 mg/dL) occurred in 3.7% of patients (93% of them in the intensive group). Mortality was higher among the patients with severe hypoglycemia (35.4% mortality rate; adjusted hazard ratio [HR] for death, 2.10) and moderate hypoglycemia (28.5%; HR, 1.41) than in those with no hypoglycemia (23.5%; HR, 1). Patients also had an increased risk of dying if they had moderate hypoglycemia on more than one day or had severe hypoglycemia while not taking insulin.

Intensive glucose control leads to hypoglycemia, which in turn is associated with increased risk of death in critically ill patients, the researchers concluded. They noted the existence of a dose-response relationship but cautioned that the data cannot establish a causal relationship. However, a causal relationship would be "plausible," according to the researchers, and is consistent with the finding that hypoglycemic patients were significantly more likely to die of distributive (vasodilated) shock.

It is also possible that the hypoglycemia was a marker rather than a cause of death, at least in some cases, such as the patients not taking insulin whose hypoglycemia likely resulted from underlying disease processes. Still, the authors concluded that critical care clinicians should work to avoid hyperglycemia and hypoglycemia in their patients, and follow current guidelines for a blood glucose target of 144 to 180 mg/dL. An accompanying editorial noted that the study showed the difficulty of implementing insulin protocols and accurately monitoring glucose. The editorialist expressed hope that new technologies for continuous glucose monitoring will help clarify the results of the NICE-SUGAR.



From ACP Journal Club


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Telemonitoring was associated with greater mortality and did not reduce hospitalizations or ED visits in high-risk elderly patients

A trial in four Minnesota primary care clinics randomized 200 elderly patients who were deemed high-risk due to their past hospitalizations and comorbid conditions (including diabetes) to home telemonitoring (using peripheral scales, blood pressure cuff, glucometer, pulse oximeter, and peak flow meter) or usual care.

They found that the telemonitoring group had a higher mortality (14.7%) compared with usual care (3.8%) and did not have fewer hospitalizations or ED visits.

The study was published in Archives of Internal Medicine on May 28. The following commentary by William J. Hall, MD, MACP, was published in the ACP Journal Club section of the Sept. 18 Annals of Internal Medicine.

The results of the study by Takahashi and colleagues will probably curb the enthusiasm of many health care systems considering investing in home-monitoring systems to reduce costly ED visits and acute hospitalizations. Why have innovative telemonitoring interventions not proven to be of more value for "bending the cost curve"? This may be an indictment of misalignments in current health care systems rather than inadequacy of the technology. Telemonitoring of health status in community-living, older adults at high risk for hospitalization is an example of a sustaining innovation—that is, it replaces costly ambulatory visits with potentially more cost-effective, remote visual communication with patients and uses ancillary technology to assess vital signs and some laboratory studies. Where telemonitoring seems to fail is that the responsibility for follow-up is left to busy primary care offices that do not have provisions or incentives to act other than the customary referral to EDs or hospitals. However, better alignment of incentives for all participants is being proposed in medical home models and accountable care organizations. Health systems that have aligned incentives among their entire health care workforce may embrace telemonitoring as a key strategy for providing care and reducing costs. At that point, any technology that facilitates more human communication with patients with chronic illness and, most important, has resources to ensure appropriate follow-up will be considered a disruptive innovation and will probably enhance health delivery for both patients and providers. Meanwhile, the study of Takahashi and colleagues does provide evidence that technology cannot substitute for sound health care delivery design and function—and may even accentuate delivery deficiencies. Future proposals for telemonitoring will need to be developed, realized, and tested before they can be recommended and should not ignore the lessons learned along the way.


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Neither n-3 fatty acid supplements nor glargine reduced CV events in patients with dysglycemia

The Outcome Reduction with an Initial Glargine Intervention (ORIGIN) trial randomized about 12,000 patients with cardiovascular (CV) risk factors and dysglycemia to basal insulin glargine or usual care and daily n-3 fatty acid supplementation or olive oil placebo. Patients in the glargine and usual care groups had similar rates of cardiovascular events and mortality, and the fatty acid supplements provided no benefits over placebo.

The glargine and fatty acid studies were published in the New England Journal of Medicine on July 26. The following commentary by Ellis Lader, MD, was published in the ACP Journal Club section of the Sept. 18 Annals of Internal Medicine.

The first of this pair of interesting studies by the Population Health Research Institute asks: Are fasting glucose levels tightly controlled with insulin beneficial in patients with or at high risk for vascular disease early in the course of diabetes? This is asked in the context of several recent trials that bring into question the benefit of tight glycemic control. Only one trial has shown a reduction in events with aggressive glycemic control in patients with type 1 diabetes. In contrast, the ACCORD trial found an increase in mortality with aggressive glycemic control in patients with type 2 diabetes; two other trials found no reduction in event rates. The ORIGIN trial also did not find any CV benefit with aggressive fasting glucose control. Is tight glycemic control no longer a valid goal? Given epidemiologic evidence for the association of higher glucose levels with increased CV risk and support for the biologic plausibility from in vivo and in vitro studies, clinicians can still support good glycemic control as a therapeutic target. However, which hemoglobin A1c (HbA1c) targets to aim for and which predictors identify patients at risk for hypoglycemia remain priority questions. In the first ORIGIN trial, the end-of-study, between-group difference in HbA1c levels was not large (median 6.2% vs 6.5%), yet the absolute increase in severe hypoglycemia was nearly 4%. One wonders whether outcomes would have been different if metformin had been used instead of insulin, given recent data from the BARI-2D trial. Finally, would this cohort of patients have been better served by a weight loss and exercise program, which might have reduced the incidence of diabetes by 58% with no risk for hypoglycemia?

The second study assessed the effects of supplemental n-3 fatty acids in the same population. n-3 or omega(ω)-3 both refer to the location of the first double bond in the fatty acid molecule. There is considerable, mainly observational, evidence that fish consumption, particularly fatty fish, can reduce CV disease and stroke, hence the interest in EPA and DHA (ω-3) supplementation, both of which are found in fish and fish oil. α-linolenic acid is found in nuts and is incompletely and undependably converted to EPA and DHA, so it is not usually considered in supplementation trials. ω-6 fatty acids may feed into biosynthetic pathways of inflammatory mediators and are also not generally supplemented. The ORIGIN investigators used a prescription-strength supplement that contained more ω-3 fatty acids than over-the-counter fish oil products. No benefit was shown other than a small reduction in triglycerides, which have never been associated with reductions in CV risk. Again, we have a good dietary observation proven ineffective when translated into a pill or capsule. Perhaps dietary fish sources contain other substances (not available in fish oil supplements) that improve CV health; fish consumption may be a marker for heart-healthy habits that improve outcomes or may displace other less healthy food from the diet; or the complex associations of ω-3 fatty acids with other substances in intact fish may deliver nutrients in ways that make them function differently from when they are provided in a purified form.

The take-home message seems to be that, at least in this population, there is no benefit to fish oil supplementation. But maybe we should all eat more fish!



Tool of the month


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Admitting a patient with diabetes to the hospital

Persons with diabetes have a two- to four-fold higher hospitalization rate than do those without diabetes. Poorly controlled diabetes has been associated with increased infectious complications, delayed wound healing, increased medical costs, increased length of stay and increased mortality.

The general goals for patients with diabetes in the acute care setting are:

  • avoiding hypoglycemia or hyperglycemia;
  • avoiding metabolic abnormalities, such as volume depletion or electrolyte abnormalities;
  • meeting nutritional needs and
  • assessing educational needs.

The initial history of the patient with diabetes who is admitted to the hospital should include the following information:

  • preadmission medications for diabetes,
  • home glucose monitoring results,
  • outpatient diet,
  • hemoglobin A1c values (if available) and
  • history or presence of complications from diabetes.

From the ACP Diabetes Care Guide.



FDA update


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Another weight loss drug approved

A combination of phentermine and topiramate extended-release (Qsymia) was recently approved by the FDA as an addition to a reduced-calorie diet and exercise for chronic weight management.

It is approved for adults with a body mass index (BMI) of 30 kg/m2 or greater or adults with a BMI of 27 kg/m2 or greater who have at least one weight-related condition such as diabetes. The drug must not be used during pregnancy or in patients with glaucoma or hyperthyroidism. The recommended daily dose contains 7.5 mg of phentermine and 46 mg of topiramate extended-release, but a higher dose (15 mg phentermine and 92 mg of topiramate extended-release) is available for select patients. It can increase heart rate, so regular monitoring of heart rate is recommended for all patients, especially when starting or increasing the dose.



Keeping tabs


.
Spotlight on the state of diabetes

From the ancient Egyptians to current pilot projects, two recent articles in the New England Journal of Medicine reviewed the history and current state of diabetes care.

In "The Past 200 Years of Diabetes," the author described progress in diabetes treatment from the development of insulin to modern advances such as home glucose monitoring, team-based care and bariatric surgery. However, he noted that there have been negative developments in the field as well, specifically the vast increase in type 2 diabetes incidence. "In fact, if one views diabetes from a public health and overall societal standpoint, little progress has been made toward conquering the disease during the past 200 years, and we are arguably worse off now than we were in 1812," he wrote.

To deal with this situation, more preventive efforts need to be evaluated and implemented, according to the article. Research should be conducted on the effectiveness of trans fat elimination, restaurant calorie posting, school cafeteria menu changes and soda taxes. "Lifestyle modification will undoubtedly play a key role in the ultimate solution to the problem of diabetes, but the necessary modifications have not been easy to implement," he added.

The other article, "What's Preventing Us from Preventing Type 2 Diabetes?", dealt specifically with the challenge of prevention. The authors, from the National Institute of Diabetes and Digestive and Kidney Diseases, discussed why the interventions of the Diabetes Prevention Program (DPP) have not been widely implemented despite evidence that they safely and cost-effectively prevent or delay onset of type 2 diabetes.

Some progress has been made to implement the program's diet and exercise lifestyle intervention, with more than 100 sites in 25 states now providing group-based programs. However, the spread of these programs is limited because most payers, including the Centers for Medicare and Medicaid Services, do not cover such services. Improving payment for certified providers of these lifestyle interventions could prevent some cases of diabetes and improve public health, the authors concluded.

The DPP's other finding, that metformin reduced development of diabetes in overweight or obese patients with prediabetes, has not been widely implemented either. This is likely due to lack of FDA approval for this indication, and because the drug is generic, no manufacturer is likely to apply for approval unless some incentive or alternate pathway is provided, the authors said. The costs and benefits of preventing diabetes need to be assessed over a long timeline, they urged.



Education


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Global diabetes summit to be held

The 2012 Global Diabetes Summit will be held Nov. 14-17, 2012, in Columbus, Ohio.

Sponsored by the The Ohio State University Wexner Medical Center's Diabetes Research Center, the summit will focus on the theme "New Horizons in Diabetes: Genetics to Personalized Health Care." International diabetes experts will present new research and focus on diabetes prevention, detection and treatment.

More information is available online.


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MKSAP Answer and Critique



The correct answer is A. Basal insulin and rapid-acting insulin before meals. This item is available to MKSAP 15 subscribers as item 26 in the Endocrinology section. Part A of MKSAP 16 was released on July 31. More information is available online.

This patient has uncontrolled diabetes mellitus during an acute medical illness requiring hospitalization. Although there are no data demonstrating improved clinical outcomes with better glycemic control in patients on general hospital wards, such treatment likely improves outcomes in the intensive care unit. Accordingly, national consensus guidelines recommend attempting to improve glycemic control in all hospitalized patients (premeal glucose level <140 mg/dL [7.8 mmol/L] and random glucose level <180 mg/dL [10.0 mmol/L]). Thus, a basal-bolus insulin regimen consisting of a long- or intermediate-acting insulin and a rapid-acting insulin analogue before meals is recommended for this hospitalized patient with diabetes mellitus. Such an approach allows for a more easily titratable regimen and can conveniently be held during diagnostic testing or procedures when nutritional intake is interrupted.

Insulin infusions are difficult to administer outside the intensive care unit in most hospitals; therefore, initiating one is not the best treatment for this patient and may not even be necessary to obtain good glycemic control.

A regimen of neutral protamine Hagedorn (NPH) insulin twice daily will likely improve glycemic control but is not as easily titratable as a basal-bolus correction and does not provide for premeal coverage to prevent postprandial glucose spikes.

Sliding scale regular insulin has been associated with increased hyperglycemic and hypoglycemic excursions and has been found to result in inferior glycemic control compared with a basal-bolus correction regimen in hospitalized patients. Initiating this approach is therefore inappropriate.

Key Point

  • There are no data demonstrating improved clinical outcomes after treatment to achieve better glycemic control in patients on general hospital wards, but such treatment has been shown to improve outcomes in critically ill patients in the intensive care unit.

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Test yourself

A 69-year-old woman is evaluated for a lump under her arm found on self-examination. She is otherwise healthy and has no other symptoms. Medical and family histories are unremarkable, and she takes no medications. A needle aspirate of the right axillary mass reveals adenocarcinoma. Bilateral mammography and breast MRI are normal. CT scan of the chest, abdomen, and pelvis demonstrates the enlarged axillary lymph node and no other abnormalities. What is the most appropriate initial treatment?

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