Diabetes Update

Diabetes Update

A collection of interview-based diabetes articles by leading experts.

Read some of our top articles on diabetic neuropathy, bariatric surgery, controlling glucose, and more.

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Table of Contents 15 New Guidelines for Diabetic Neuropathy

— John D. England, MD, FAAN

18 Individualizing Comprehensive Diabetes Care — Yehuda Handelsman, MD, FACP, FACE, FNLA

13 Diabetes-Related LEAs: The Impact of Location — David J. Margolis, MD, PhD

16 Bariatric Surgery for Diabetes: Significant Benefits Observed — Jon C. Gould, MD

20 Controlling Glucose: Mobile Apps to the Rescue — Michael L. Terrin, MD, CM, MPH

22 Meauring the Quality of Diabetes Care — Patrick J. O’Connor, MD, MPH

Management

President Clay Romweber

VP, Product Marketing & Development Tom Richards

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Sales

Business Dev. Managers Dave Dempsey Mark Elms Dennis Turner Luke Williams

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Editorial Director Keith D’Oria

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Mngr Hospital Relations Jacquie Jacovino

Physician’s Weekly™ (ISSN 1047-3793) is published by Physician’s Weekly, LLC, a division of M/C Holding Corp. The service is free for qualifying institutions. Please contact us at [email protected] for more information. Offices: Physician’s Weekly, LLC, 5 Commerce Way, Suite 202, Hamilton, NJ 08691; and 180 Mount Airy Road, Suite 102, Basking Ridge, NJ 07920. Reproduction without written permission from the publisher is prohibited. Copyright 2012, Physician’s Weekly, LLC.

Publication of an advertisement or other product mention in Physician’s Weekly should not be construed as an endorsement of the product or the manufacturer’s claims. The appearance of or reference to any person or entity in this publication (including images) does not constitute an expressed or implied endorsement of the product mentioned. The reader is advised to consult appropriate medical literature and the product information currently provided by the manufacturer of each drug to verify indications, dosage, method, duration of administration, and contraindications. All editorial is developed independent of influence from advertising brands/companies.

A Message From the EditorWe at Physician’s Weekly are excited to present you with an eBook dedicated to feature stories we’ve covered on diabetes-related topics. In recent months, our publication has published a variety of news items in this field, focusing on clinical and evidence-based research. The content in these articles relies on the expertise of our contributing physician authors. Physician’s Weekly will continue to feature diabetes news in the coming months, and we hope that you find this information useful in your practice. Please let us know your thoughts at the Contact Us page here.

Sincerely,

Keith D’Oria Editorial Director, Physician’s Weekly

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The prevalence of neuropathy among those with diabetes has been estimated to be as high as 50%. Painful diabetic neuropathy (PDN),

which tends to affect the feet and legs, has been esti-mated to affect roughly 16% to 20% of the more than 25 million people in the United States who are living with diabetes. The condition often goes unre-ported and even more are untreated, with an esti-mated 40% of patients not receiving care for PDN.

A Need for Guidance“Painful diabetic neuropathy is a big problem for all healthcare providers who treat patients with dia-betes,” says John D. England, MD, FAAN. “There are increasingly more drugs being developed and brought to market that can be used for treating dia-betic neuropathy. For a busy practitioner, it’s often difficult to keep up with all of the new evidence and to decide what a rational, tiered approach should be to treatment.” Part of the issue is the volume of lit-erature on the topic. In 2007, when members of the American Academy of Neurology (AAN) felt there was a need to update guidelines for the treatment of PDN, the process started with more than 2,200 papers. Of them, 463 were deemed relevant and 79 were highly pertinent to the guidelines. Since then, many more studies have emerged.

John D. England, MD, FAANThe Grace Benson Professor and Head of

NeurologyLouisiana State University Health Sciences

Center School of MedicineFellow

American Academy of Neurology

New Guidelines for

Diabetic NeuropathyThe American Academy of Neurology has released new

guidelines on the management of painful diabetic neuropathy that provide evidence-based information

on use of a range of treatment strategies.



In the May 17, 2011 issue of Neurology, the AAN published its first evidence-based guidelines on use of a range of pharmacologic and non-pharmaco-logic treatments for diabetic neuropathy. “There is no ‘cookbook’ approach to treatment for PDN,” explains Dr. England, who co-chaired the AAN panel that developed the guidelines. “We can, however, use the scientific evidence in the literature and make sure that it conforms to our clinical judg-ment and patient preferences. What one patient may respond to may be very different from that of another. The evidence provides some guidance on how we should treat this complication of diabetes.” Dr. England adds that it is important to explain to patients that it is not common for patients to

achieve complete pain relief even though medica-tions are available to help relieve some of their pain.

Key RecommendationsPhysicians need to be particularly careful with pain measurements because pain is a subjective com-plaint, says Dr. England. “Pain is measured with standardized scales, but what level of pain relief is actually experienced by patients is a subjective response. That is why well-studied research popula-tions are needed. We want to exclude any potential confounding factors. Over the past couple decades, the AAN has developed a robust system for classify-ing evidence from the therapeutic trials that study this patient population.”

Table 1 Summarizing Treatment Recommendations

Level A

Level B

Recommended Drug and Dose

Pregabalin, 300–600 mg/day

Gabapentin, 900–3600 mg/day

Sodium valproate, 500–1200 mg/day

Venlafaxine, 75–225 mg/day

Duloxetine, 60–120 mg/day

Amitriptyline, 25–100 mg/day

Dextromethorphan, 400 mg/day

Morphine sulphate, titrated to 120 mg/day

Tramadol, 210 mg/day

Oxycodone, mean 37 mg/day, max 120 mg/day

Capsaicin, 0.075% qid

Isosorbide dinitrate spray

Electrical stimulation, percutaneous nerve stimulation x 3–4 weeks

Not Recommended

Oxcarbazepine

Lamotrigine

Lacosamide

Clonidine

Pentoxifylline

Mexiletine

Magnetic field treatment

Low-intensity laser therapy

Reiki therapy

Source: Adapted from: Bril V, et al. Neurology, 2011;76:1758-1765. Available at www.neurology.org/content/early/2011/04/08/WNL.0b013e3182166ebe.

Physicians should refer to the AAN guidelines to learn which drugs have the best scientific evidence supporting their use to treat PDN.

— John D. England, MD, FAAN


Using this system, Dr. England and colleagues rated the level of evidence for several therapeutic modali-ties that can be used to treat patients with PDN. “It should be noted that many of these patients have severe enough pain that they require multiple modalities to help them,” noted Dr. England. He adds that most of the agents listed in Table 1 reduce pain by 30% to 50%, on average. Therefore, mixing and matching agents and other therapies is often

required to help patients feel as comfortable as pos-sible. “In addition, several agents are still being used to treat this population when there is either insuf-ficient evidence to support or even evidence against their use,” says Dr. England. “Physicians should refer to the AAN guidelines to learn which drugs have the best scientific evidence supporting their use to treat PDN.”

A Need for ChangeDr. England says special attention should be paid to the medications indicated for PDN that have level B recommendations. “Unfortunately, the paucity of data makes it challenging for physicians to truly know which therapeutic interventions are better and the ideal candidates for each option,” he says. “We need comparative effectiveness trials to determine which drugs in the treatment of PDN are superior.”

Among other changes Dr. England would like to see made in research is the selection of a single pain rating scale (Table 2). “Using such a scale in all trials would enable investigators to compare trials against each other with greater accuracy. Also, aside from a few recent studies, most analyses only measure pain relief. They should also measure quality of life and function. Patients could have some pain relief but still experience deteriorated quality of life and function, depending on adverse events from medi-cations. We have come a long way in improving the management of diabetic neuropathy, but we still have a long way to go. The only way that we’re going to get better is to fund more research.”

John D. England, MD, FAAN, has indicated to Physician’s Weekly that he serves on the speakers’ bureau for and has received funding for travel or speaker honoraria from Talecris Biotherapeutics

and Teva Pharmaceutical Industries. He also receives research support from the NIH/NINDS, AstraZeneca, and Pfizer, and holds stock/stock options in Pfizer and Talecris Biotherapeutics. For more information on this article, including references, visit www.physiciansweekly.com.

Table 2 Recommendations for Future Research

• A formalized process for rating pain scales for use in all clinical trials should be developed.

• Clinical trials should be expanded to include effects on quality of life and physical function when evaluating efficacy of new interventions for painful diabetic neu-ropathy (PDN); the measures should be standardized.

• Future clinical trials should include head-to-head comparisons of different medications and combinations of medications.

• Because PDN is a chronic disease, trials of longer duration should be done.

• Standard metrics for side effects to qualify effect sizes of interventions need to be developed.

• Cost-effectiveness studies of different treatments should be done.

• The mechanism of action of electrical stimulation is unknown; a better understanding of its role, mode of application, and other aspects of its use should be studied.

Source: Adapted from: Medical Care Criteria Committee. Hepatitis C. New York State Department of Health AIDS Institute. Available at: www.hivguidelines.org/clinical-guidelines.


Patients with diabetes suffer from multiple comorbidities and complications and fre-quently experience decreased quality of life,

as well as earlier mortality. About one-third of Americans have diabetes or prediabetes, accord-ing to the American Association of Clinical

Endocrinologists (AACE), based on data from the CDC. Through early recognition, patients with dia-betes can achieve a higher quality of life by being diagnosed appropriately (Table 1) and by receiving intensive interventions to get patients to treatment goals safely.

Several medical societies and associations have estab-lished clinical guidelines that address the prevention, diagnosis, and/or management of diabetes. Most offer a plethora of useful infor mation, but it can be challenging for clinicians to find specific informa-tion that they need easily and quickly. With this in mind, along with awareness that much has changed in diabetes care in recent years, AACE created the 2011 Medical Guidelines for Clinical Practice for Developing a Diabetes Mellitus Comprehensive Care Plan. “We decided to simplify the guidelines,” says

New clinical practice guidelines from the American Association of Clinical Endocrinologists emphasize the importance of individualized care when developing comprehensive care plans for patients with diabetes.

Individualizing Comprehensive Diabetes Care

Yehuda Handelsman, MD, FACP, FACE, FNLAPresident American Association of Clinical

EndocrinologistsMedical Director & Principal Investigator Metabolic Institute of AmericaChair and Founder International Committee for Insulin

Resistance Senior Scientific Consultant Metabolic Endocrine Education Foundation

8




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http://www.physiciansweekly.com/individualizing-comprehensive-diabetes-care/


co-chair Yehuda Handelsman, MD, FACP, FACE, FNLA. “We identified 20 important questions and chose 23 of the country’s top leaders in those areas to answer them.” The guidelines provide roughly five pages of answers per subject matter. A more in-depth executive summary provides specific answers to each of the 20 questions.

A Comprehensive ApproachPrevious guidelines from AACE and other groups have identified diabetes-related issues like blood pressure, heart disease, and lipids. However, Dr. Handelsman says these documents usually do not stress that clinicians should cover all of these domains when they see patients. “Only about 40% to 50% of the population with diabetes reaches reasonable blood glucose control,” he says. “For blood pressure goals, only about 50% to 60% reach goal, and the rate is about 50% for lipids. Importantly, control of all three of these factors is only about 10% to 12% among patients with diabetes. The hope is that the comprehensive care guidelines developed by AACE will encourage providers to treat patients beyond the achievement of appropriate glucose levels.”

Personalized CareAn important strategy that the AACE guidelines emphasize is that one size does not fit all when it comes to managing patients. “We do not believe

that there’s an average patient and that everyone’s like the average patient,” explains Dr. Handelsman. “That’s the equivalent of saying everyone has 2.3 kids or that everyone makes $60,000 per year. Greater efforts are needed by clinicians to spend extra time and individualize goals based on the patient’s unique

characteristics and risk factors. Developing a person-alized treatment plan based on individualized goals will ultimately enhance care and hopefully improve outcomes for this growing patient population.”

The AACE guidelines were developed with the belief that the majority of patients are able to reach a target

A1C level of 6.5% or less, provided this can be done safely. A1C levels may vary based on patients’ risk for developing hypoglycemia, liver disease, weight gain, or other diabetes-related issues. “We recognize that some patients with diabetes or prediabetes may be younger, have the disease for a shorter time, or do not

Table 1 Prediabetes Risk Factors Suggesting a Need for Screening

• Family history of diabetes.

• Cardiovascular disease.

• Being overweight or obese.

• Sedentary lifestyle.

• Non-Caucasian ancestry.

• Previously identified impaired glucose tolerance, impaired fasting glucose, and/or metabolic syndrome.

• Hypertension.

• Increased levels of triglycerides, low concentrations of HDL cholesterol, or both.

• History of gestational diabetes.

• Delivery of a baby weighing more than 4 kg (9 lb).

• Polycystic ovary syndrome.

• Antipsychotic therapy for schizophrenia and/or severe bipolar disease.

Source: Adapted from: Handelsman Y, et al. Endocr Pract. 2011;17(Suppl 2):1-53.

The hope is that the comprehensive care guidelines developed by AACE will encourage

providers to treat patients beyond the achievement of appropriate glucose levels.

— Yehuda Handelsman, MD, FACP, FACE, FNLA


have any other comorbid conditions,” Dr. Handels-man says. “There is also a group of people who are very sick and have many diabetes-related comorbidi-ties. They’re frail, are prone to low blood sugars, and have short longevity. For these patients, clinicians need to be guided more by clinical sense, expertise, and knowledge rather than defined one-size-fits-all goals. The important thing to remember is there isn’t a cookie-cutter approach to this disease. By thor-oughly and comprehensively seeking to get patients to target levels of diabetes-related comorbidities, the likelihood of long-term benefits increases.”

Teamwork Matters The new AACE guidelines include an entire sec-tion on the utilization of multidisciplinary team approaches to diabetes care, placing much stress on the need for diabetes education and the use of dieti-cians, physiologists, podiatrists, and others as patients with diabetes receive care (Table 2). This may require that physicians take extra steps to create and establish these teams. “Physicians should be prepared with other team members so that patients with diabetes have immediate access to cardiologists, eye doctors, neuropathy and kidney specialists, diabetes self-man-agement educators, dieticians, and fitness centers or gyms. Expecting patients to seek out these physicians on their own after a diabetes diagnosis is unrealistic. By being prepared with this multidisciplinary team, the chances of improving quality of life and diabetes-related outcomes increase substantially.”

Yehuda Handelsman, MD, FACP, FACE, FNLA, has indi cated to Physician’s Weekly that he worked

as a consultant for Daiichi Sankyo, Gilead, Genentech, GlaxoSmithKline, Merck, XOMA,

and Tolerx. He has worked as a paid speaker for AstraZeneca, Boehringer Ingelheim, Bristol-Myers

Squibb, Daiichi Sankyo, GlaxoSmithKline, Merck, and Novo Nordisk. He has also received grants/research aid from Boehringer Ingelheim,

Daiichi Sankyo, GlaxoSmithKline, Novo Nordisk, Takeda, sanofi-aventis, XOMA, and Tolerx.

For more infor mation on this article, including references, visit www.physiciansweekly.com.

Table 2 Education and Team Approaches in Diabetes Management Guidelines from the American Association of Clinical Endo-crinologists recommend that a team be involved in diabetes care to help patients learn in-depth information about a variety of topics related to their health concerns. The roles of the diabetes care team are as follows:

Certified Diabetes Educators

• Teach in a variety of inpatient and outpatient settings.

• Educate patients on all topics related to diabetes management.

• Often have more time than physicians to devote to each patient.

Registered Dietitians

• Develop healthful eating plans and can relate diabetes education.

• Document problems (eg, disordered meal patterns, timing of meals, eating disorders, lack of money for food, or other physiological and psychosocial problems).

• Identify issues that may not be identified during physician office visits.

Registered Nurses

• Provide an assessment before physicians see patients, allowing for better focus on any identified problems.

• Teach patients about medication administration, assessment of medication tolerability, and other diabetes-related management issues.

Nurse Practitioners and Physician Assistants

• Can set up treatment plans and set goals that other team members will implement in patient care, allow-ing physicians to focus on specific treatment issues.

• Often take over some treatment decisions, thus freeing physicians to concentrate on other healthcare issues.

Primary Care Physicians

• Address diabetes and other aspects of care beyond diabetes alone.

• Relieve the role of specialists (eg, cardiologists, nephrologists, etc).

• Can recommend when it is important for patients to see specialists as part of their care.

Source: Adapted from: Handelsman Y, et al. Endocr Pract. 2011;17(Suppl 2):1-53.



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A bout 80,000 lower-extremity amputations (LEAs) are performed each year on patients with diabetes in the United States. Statistical

analyses have shown that the annual incidence of LEA in older patients with diabetes was 5.0 per 1,000 in 2006-2007, but decreased to 4.0 per 1,000 in 2008. “While the downward trend is encour-aging, it’s important to also analyze variations in the rates of LEAs throughout the country,” says David J. Margolis, MD, PhD.

Previous studies have shown that there appears to be geographic variation in the incidence of LEAs among Medicare beneficiaries with diabetes. Furthermore, about $52,000 is reimbursed annually for a Medicare beneficiary with diabetes and an LEA. “By learning more about geographic variation in LEA, we can then identify causes and develop targeted interventions for prevention,” Dr. Margolis says.

Assessing Geographic VariationIn the November 2011 issue of Diabetes Care, Dr. Margolis and colleagues conducted a study to explore geographic variation of incident LEAs among Medi-care beneficiaries with diabetes. The investigators performed a study of the full population of Medi-care beneficiaries because it is, in essence, the largest healthcare insurance provider in the U.S. and the largest government-funded medical entitlement pro-

David J. Margolis, MD, PhD Professor of Biostatistics and Epidemiology Professor of DermatologyCenter for Clinical Epidemiology

and Biostatistics University of Pennsylvania

Perelman School of Medicine

Diabetes- Related LEAs: The Impact of Location

A new study has found that rates of foot and leg amputations among Americans with diabetes may vary widely according to where they live.



gram. The geo graphic unit of analysis was hospital referral regions (HRRs). The study then evaluated the incidence of LEA by HRRs as a function of geo-graphic location throughout the country. Other items analyzed in the study included sociodemographic fac-tors, risk factors for LEA, diabetes severity, provider access, and cost of care.

“Our findings showed that rates of amputation varied greatly according to where patients lived, but questions remain as to why this occurs,” says Dr. Margolis. “While previous studies have suggested that rates of amputation may be declining among Americans with diabetes, our analysis suggests that LEA rates can be almost double the national average among older Americans in some parts of the U.S.”

The incidence of LEA was highly concentrated in neighboring HRRs. In 2008, disproportionately high rates of LEA existed in certain pockets of southeast Texas, southern Oklahoma, Louisiana, Arkansas, and Mississippi (Figures 1 & 2). For these locations, the LEA rate ranged from 7.0 to 8.0 per 1,000. “These findings are important, considering the national rate that same year was 4.5 per 1,000,” Dr. Margolis adds. “On the other hand, we observed disproportionately low rates of LEA throughout southern Florida as well as parts of New Mexico, Arizona, and eastern Michigan. In these spots, Medicare beneficiaries with diabetes had amputa-tions at a rate of 2.4 to 3.5 per 1,000.”

Dr. Margolis notes that accounting for geographic location greatly improved the researchers’ ability to understand the variability in LEA. Additionally, covariates associated with LEA per HRR included:

Interpreting FindingsDr. Margolis and colleagues were able to account for the prevalence of diabetes in a given area, the number of people diagnosed with diabetic foot ulcers, and an area’s socioeconomic status. However, these factors accounted for some of the geographic variation, but not all of it. It is also important to note that the relatively high rates of LEA in certain

Figure 1 LEA: Mapping the Overall IncidenceThe map below is of LEA incidence per 1,000 people on Medicare with diabetes. The legend depicts the hospital referral regions in 2008.

Abbreviation: LEA, lower extremity amputation.

Source: Adapted from: Margolis DJ, et al. Diabetes Care. 2011; 34:2363-2367.

2.4-3.5

3.6-4.6

4.7-5.7

5.8-6.8

6.9-7.9

• Socioeconomic status.

• Prevalence of African Americans.

• Age.

• Diabetes.

• Mortality rate associated with having a foot ulcer.

By learning more about geographic variation in LEA, we can then identify causes and

develop targeted interventions for prevention.— David J. Margolis, MD, PhD


regions do not necessarily mean that the rates are too high, Dr. Margolis says.

“It’s possible that physicians in areas of high rates of LEA see more people with severe diabetes complica-tions,” explains Dr. Margolis. “Based on their experi-

ences, they may believe that an earlier amputation correlates with better outcomes. Currently, the deci-sion to perform LEA is not clear-cut. Furthermore, there are no general guidelines on when amputations should be performed in individuals with severe dia-betic ulcers. This means the decision for LEA relies on physician judgment and patient preference.”

More Research NeededConsidering the results of the investigation, Dr. Margolis believes more research is needed to better understand the reasons for geographic vari-ations with LEA in Medicare beneficiaries with diabetes. “Ideally, we want to look more closely at the areas of high and low LEA rates in an effort to determine the causal factors. Doing so will enable researchers to target interventions to further reduce the rate of LEAs. This will require gather-ing data on clinician education in LEA, the role of patient preferences, and information on genetic risk factors that predispose patients to LEA. Until these data emerge, clinicians should strive to help people with diabetes take the necessary steps to protect their limbs.”

David J. Margolis, MD, PhD, has indicated to Physician’s Weekly that he has or has had no financial interests to report. For more information on this article,

including references, visit www.physiciansweekly.com.

Figure 2 LEA: Mapping the Highest & Lowest IncidenceThe map below is a local index of spatial autocorrelation of LEA incidence. It shows spatially correlated HRRs of highest and lowest incidence of LEA in 2008.

Abbreviation: LEA, lower extremity amputation. HRRs, hospital referral regions.

Source: Adapted from: Margolis DJ, et al. Diabetes Care. 2011; 34:2363-2367.

Low Low

High High


In the United States, more than 90% of 25.8 million adults with diabetes have type 2 disease, according to the CDC. More than 1.9 million

cases were diagnosed in 2010 alone among adults aged 20 and older. Approximately 90% of type 2 diabetes has been attributable to excess weight and obesity. “The results of noninvasive interventions for type 2 diabetes and obesity, such as lifestyle changes and pharmacotherapy, have been disappointing,” says Jon C. Gould, MD. “Bariatric surgery appears to be one of the most effective, long-lasting treatments

for obesity. In many clinical trials, these procedures have been quite effective for individuals who are obese and have type 2 diabetes.”

Riveting New DataIn the June 2011 Archives of Surgery, a systematic review was published demon-strating that bariatric surgery leads to marked and long-lasting weight reduction, and may be capable of improving or even curing type 2 dia betes. The analysis reviewed findings from nine studies that followed obese patients with diabetes who underwent either gastric bypass or gastric band-ing for 1 year. Rick Meijer, MD, and colleagues from Amsterdam found that Roux-en-Y gastric bypass led to a reversal rate of type 2 diabetes of 83%. Adjustable gastric banding led to a reversal rate of 62%, and this effect was achieved later after surgery (Figure 1).

Jon C. Gould, MD Associate Professor and ChiefAlonzo P. Walker Chair in Surgery Medical College of WisconsinSenior Medical Director of Clinical

Operations Froedtert Hospital

16

Bariatric Surgery for Diabetes: Significant

Benefits ObservedMany studies have shown various benefits with bariatric

surgery in patients who have diabetes, but results from a new systematic review suggest that most of these individuals could actually be cured of their disease following these procedures.




http://www.physiciansweekly.com/bariatric-surgery-for-diabetes/


“The presence of diabetes is a compelling argument to perform bariatric surgery in eligible patients according to nationally recognized criteria for the procedure,” says Dr. Gould. “Dr. Meijer’s study showed that glycemic control improved in the months after laparoscopic adjustable gastric banding, but it improved more

rapidly and completely after laparoscopic Roux-en-Y gastric bypass surgery. In the end, both types of surgery were capable of improving or even curing type 2 diabetes, but the mechanisms may be different. It appears that surgeons should consider bariatric surgery earlier in the treatment of obese patients with diabetes to improve long-term outcomes.”

According to the study by Dr. Meijer and colleagues, the underlying mechanisms leading to improved

glycemic control after bariatric surgery only have been partly elucidated. There are several mechanisms that should be considered responsible for the resolution of diabetes after bariatric surgery (Figure 2). “Hopefully, more data will emerge on the mechanisms of the resolution of diabetes related to which bariatric procedures are performed in obese patients with diabetes,” adds Dr. Gould.

In addition to the beneficial effects on type 2 diabetes, improvements in other important risk factors partly explain the reduced mortality rates that have been observed after bariatric surgery. For example, hypertension improves in about 80% of patients after they receive their operation. Other studies have shown that hyper cholesterolemia and hypertriglyceridemia improve after surgery. Furthermore, cardiac function appears to improve, and obstructive sleep apnea appears to lessen postoperatively.

Weigh the Pros & ConsDr. Gould believes that the high upfront costs of bariatric surgery can be recouped within 18 months to 2 years when compared with the extended costs of managing diabetes and other obesity-related health issues. The study by Meijer et al found that the average medical expenditures among those

with diabetes were 2.3 times higher than those among non-diabetic patients. “Eventually, people with diabetes develop serious complications that are very costly to manage,” says Dr. Gould. “Early intervention with bariatric surgery may help alleviate these costs.”

Like any operation, bariatric surgery has potential complications that should be considered. “That said,” Dr. Gould says, “bariatric surgery is continually

Surgeons should consider bariatric surgery earlier in the treatment of obese patients with

diabetes to improve long-term outcomes.— Jon C. Gould, MD

Reve

rsal

Rat

e of

DM

2, %

100

80

60

40

20

0RYGB

InterventionLAGB/AGB Control

Figure 1 Diabetes Reversal Rates After Bariatric SurgeryThe figure above describes the reversal rates of Roux-en-Y gastric bypass (RYGB) and adjustable gastric banding (AGB) and laparoscopic AGB (LAGB) for conventionally but intensively treated patients with type 2 diabetes mellitus (DM2).

Source: Adapted from: Meiger R, et al. Arch Surg. 2011;146:744-750.


becoming safer, with fewer complications following these procedures. Weight regain is another possibil-ity for patients who undergo bariatric surgery, and there may be several reasons as to why this occurs. In order to avoid these problems, physicians must spend time up front with patients to ensure that they overcome any issues that may impact their ability to keep the weight off.”

Dr. Gould also stresses the importance of post-operative care. Follow-up programs should go beyond simply ensuring that incisions have healed appropriately to achieve positive long-term results by addressing dietary, psychologic, and other ongoing issues. “The benefits of bariatric surgery can wear off

if the proper postoperative care isn’t addressed,” he says. “Fortunately, the establishment of Centers of Excellence programs can enhance outcomes so that bariatric surgery is safer than ever before.”

Gaining AcceptanceAccording to Dr. Gould, bariatric terminology puts the focus on weight, which is why he prefers the term metabolic surgery. He says “bariatric surgeons have battled biases about these operations and about obesity in particular. The perception in the community is that bariatric surgery is an elective, cosmetic procedure. Referring to this surgery as a metabolic procedure may improve the perception of these procedures in the future.”

Jon C. Gould, MD has indicated to Physician’s Weekly that he has or has had no financial interests to report. For more information on this article, including references, visit www.physiciansweekly.com.

Reve

rsal

Rat

e of

DM

2, %

40

20

0RYGB

InterventionLAGB/AGB

Increased adiponectin,

decreased leptin, decreased TNF, decreased IL-6

Increased insulin sensitivity

Increased insulin sensitivity

Decreased ghrelin

Decreased glycemic load

Decreased caloric intake

Decreased liver fat

Duodenal bypass

Decreased FFA

Increased GLP-1

Increased glycemic control

Increased insulin

secretion

Decreased hepatic glucose

production

Decreased peripheral

adipose tissue

Malabsorption

LAGBRYGB

Figure 2 Mechanisms of Bariatric Surgery on Glucose Metabolism

Abbreviations: FFA, free fatty acids; GLP-1, glucagon-like peptide; IL-6, interleukin 6; LAGB, laparoscopic adjustable gastric banding; RYGB, Roux-en-Y gastric bypass; TNF, tumor necrosis factor

Source: Adapted from: Meiger R, et al. Arch Surg. 2011;146:744-750.


In the United States, diabetes affects 25.8 million people, for whom the costs of care exceed $100 bil-lion annually. Clinical trials suggest that improved

self-care and lifestyle changes can lead to better dia-betes-related outcomes. Unfortunately, other studies indicate that just 55% of patients with type 2 diabe-tes receive diabetes education, and only 16% report adhering to recommended self-care practices. Part of

the problem behind the poor dissemination of and adherence to behavioral interventions is that patients with diabetes are generally limited to 15-minute office visits with their primary care providers. In that short period, it’s often challenging for physicians and healthcare providers to thoroughly educate patients on their disease. Further complicating the issue is that many patients do not have access to one-on-one or group interventions that can enhance adherence to important self-care practices.

Testing a New InterventionIn a study published in the September 2011 issue of Diabetes Care, my colleagues and I tested a diabetes coaching system for patients with type 2 diabetes. The system uses mobile phone applications and patient/provider portals to provide feedback on self-

Michael L. Terrin, MD, CM, MPHProfessor of Epidemiology and Public

Health University of Maryland School of Medicine

Controlling Glucose: Mobile Apps to

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management and blood glucose results. It also collects data on lifestyle behaviors and clinical man-agement. The hope was that this program could reduce A1C levels over 1 year.

In our analysis, three intervention groups consisting of patients and physicians received different amounts of information. Maximal treatment consisted of auto-mated, real-time education and behavioral messaging in response to individually analyzed blood glucose values, diabetes medications, and lifestyle behaviors communicated by cell phone. Quarterly reports were given to providers that summarized patients’ glycemic control, medication management, lifestyle behaviors, and evidence-based treatment options.

For patients who participated in the maximal inter-vention group, we found an average decline in A1C of 1.9%, compared with a 0.7% decline for those receiv-ing usual care. Although no differences were seen between groups in blood pressure, lipid levels, diabetes distress, or depression, these areas were not specifically addressed by the intervention. In order to influence these other important aspects of diabetes care, it’s clear that smartphone apps and/or website portals need to be created specifically to address known behavioral interventions that are effective for each condition.

Addressing ApplicabilityPracticing physicians can apply our results to patients with diabetes who are well managed with the excep-tion of their A1C levels. However, smartphone apps and website portals that emerge in the future will need to address other important behavioral interven-tions to maximize their potential in the care of patients with diabetes.

A Promising FutureIn the U.S., the number of mobile phone users increased from 34 million in 1995 to 290 million in 2010. Mobile phone and internet users are also becoming more diverse in age and race. The wide-spread distribution of electronic communications like smartphone apps and web portals is making it easier to process and share data in real time, making these modalities ideal for the development of simple, effec-tive, diabetes management platforms and programs. The mobile phone and web portal communication strategy we used in our study is likely to be one of many that will be developed, tested, and used as we strive to improve how we manage patients with diabe-tes in the future.

The widespread distribution of electronic communications like smartphone apps

and web portals is making it easier to process and share data in real time.

Michael L. Terrin, MD, CM, MPH, has indicated to Physician’s Weekly that he has no financial disclosures to report. For more information on this article, including references, visit www.physiciansweekly.com.



In 1995, the National Committee for Quality Assurance began the process of developing quality performance measures for diabetes care, which have

become more sophisticated with time. Diabetes was one of the first conditions for which quality measures were developed because many disease-related factors can be quantified.

Impact of Quality MeasuresIn the July 2011 issue of Diabetes Care, my colleagues and I published a consensus statement sponsored by the American Diabetes Association on the impor-tance of diabetes quality measures. In our analysis, we found that diabetes care has improved dramatically since 1995. For example, the median national A1C goal was 8.6% in 1995, but it is now around 7.0%. Median systolic blood pressure and LDL cholesterol measurements have also dropped substantially. Physi-cians, most notably primary care physicians but also diabetes educators and endocrinologists, should be largely credited for these improvements because they

Patrick J. O’Connor, MD, MPHSenior Clinical Investigator HealthPartners Research Foundation


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Measuring the Quality of Diabetes Care

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have changed their approaches to managing the dis-ease. It’s clear that quality measures for diabetes are here to stay and have contributed to at least some of the momentum toward improved care in recent years.

The potential unintended consequences of diabetes quality measures are a cause of concern. Standards of care proposed by the American Diabetes Association indicate that an A1C of less than 7.0% is appropriate for some patients while 8.0% is appropriate for others. The simplest solution would be to set the A1C target at less than 8.0% for quality measures, giving provid-ers flexibility to tailor A1C goals based on individual patients.

Financial incentives for clinicians who reach quality targets for nearly all patients are another concern. We must adjust quality measures based on patient charac-teristics or we could inadvertently incentivize doctors to stop working in low–income, safety-net clinics. This may erode our care delivery system for the most challenging and needy populations.

Future Quality MeasuresPatient preferences are critically important in the care of diabetes, but understanding the risks and benefits of different treatment goals can be a complicated issue. Patients need to be educated so that they understand risks and benefits of different A1C targets and treat-

ments, and then weigh in on their treatment prefer-ences. Attention to patient preferences should be incorporated into quality measures.

Large employers and CMS are interested in applying diabetes quality measures at the individual physician level. We will likely see movement in this direction in coming years. Another big push is to include measures of resource use to diabetes quality measures. The hope is that resource use measures will encourage clinicians to use the most cost-effective treatment strategies to get their patients to agreed upon and appropriate qual-ity targets.

Key elements of the diabetes outpatient cost equations are frequency of office visits and choice of glucose-lowering and hypertension medications. Telephone and social media-related clinical encounters may substitute some office visits at lower cost if these novel “clinical encounters” can maintain quality of care. Widespread use of outpatient electronic medical records will also accelerate measurement of quality and open the door to new quality measures, such as patient-reported satisfaction, provision of lifestyle advice or education, and identification of depression or smoking status. In the end, such information will collectively help providers improve their treatment of patients and may reduce the burden of diabetes and its complications in many of our patients.

Quality measures for diabetes are here to stay and have contributed to at least some of the momentum

toward improved care in recent years.

Patrick J. O’Connor, MD, MPH, has indicated to Physician’s Weekly that he has no financial disclosures to report. For more information on this article, including references, visit www.physiciansweekly.com.


Documents

Diabetes Update