Normal weight at diabetes diagnosis associated with higher mortality among adults.


Patients who develop diabetes at a normal weight may be at higher risk for mortality compared with those who are overweight or obese at diagnosis, according to data from a pooled longitudinal analysis of five cohort studies.

The study included 2,625 patients (aged >40 years, 50% women) from the Atherosclerosis Risk in Communities (ARIC) study, Cardiovascular Health Study (CHS), Coronary Artery Risk Development in Young Adults (CARDIA) study, Framingham Offspring Study (FOS), and the Multi-Ethnic Study of Atherosclerosis (MESA) who developed incident diabetes.

Researchers chose the studies based on repeated measures of body weight, fasting glucose level and medication use. Other factors included demographic characteristics, health behaviors and clinical factors, as well as follow-up for events and mortality, researchers wrote.

Mercedes R. Carnethon, PhD, from the department of preventive medicine at Feinberg School of Medicine at Northwestern University, and colleagues found that the portion of patients who were normal weight at the time of incident diabetes ranged from 9% to 21% (overall 12%). Additional data found that 449 patients died during follow-up, including 178 from cardiovascular causes, 253 from noncardiovascular causes and 18 causes not classified.

Within the pooled patient sample, total (284.8 per 10,000 person-years); CV (99.8 per 10,000 person-years); and non-CV mortality (198.1 per 10,000 person-years) were higher in normal-weight patients, compared with rates among overweight or obese patients.

“These patterns are consistent for total and non-CV mortality within each cohort and present for CV mortality in CHS and FOS,” researchers wrote. “Mortality rates were markedly higher in CHS cohort participants who were older, on average, than other cohort participants.”

Once adjustments were made for demographic characteristics and BP, lipid levels, waist circumference and smoking status, HRs compared normal-weight patients with overweight/obese patients for total (HR=2.08; 95% CI, 1.52-2.85); CV (HR=1.52; 95% CI, 0.89-2.58); and noncardiovascular mortality (HR=2.32; 95% CI, 1.55-3.48).

Researchers concluded that the mechanisms to explain their findings remain unknown. They recommend further studies research normal-weight patients with diabetes as they apply to other mechanisms, such as inflammation, distribution and action of adipose tissue, atherosclerosis and position of fatty plaques and pancreatic beta-cell function.

  • Source: Endocrine Today.

 

 

 

Diabetes educators review 2012 National Standards.


Last revised in 2007, the National Standards for Diabetes Self-Management Education have served as the acceptable guide for providing consistency and quality through the delivery of diabetes education. At the American Association for Diabetes Educators annual meeting, certified diabetes educators discussed the recently updated standards, emphasizing support and a continuum of self-management, as well as a widened criterion for eligible instructors.

One obvious revision includes a change in the standard’s title. Formerly known as the National Standard for Diabetes Self-Management Education, the guide is now known as the National Standard for Diabetes Self-Management Education and Support (DSMES).

Donna Tomky, MSN, RN, C-NP, CDE, FAADE, immediate past president of AADE and nurse practitioner and diabetes educator from ABQ Health Partners in Albuquerque, NM, said support is a very important part of the change.

 

Donna Tomky

“It really defines those activities that assist the person with prediabetes or diabetes in implementing and sustaining the behaviors needed to manage his or her condition on an ongoing basis. It really looks at the continuum instead of just a one-time effort,” Tomky said during a presentation.

Tomky said there are misunderstandings surrounding the standards. For example, an RN, RD, pharmacist, medical director or CDE are not needed for a diabetes education program. The revisions will be published in the October issue of Diabetes Care, she said.

Co-presenter, Melinda Maryniuk, RD, Med, CDE, director of clinical education programs for the Joslin Diabetes Center in Boston, Mass., said the revisions are aimed to ensure wide applicability and to ensure quality care.

“There aren’t revolutionary new things that have come out, but we have more research to support the information,” Maryniuk said.

In a survey of 225 public comment reviewers consisting of RNs, RDs, pharmacists, MD/DO/Endo, mental health professionals, and other providers, 82% said the standards were applicable to them, Tomky and Maryniuk said. Additionally, 74% agreed the document was clear. Many of the comments received mentioned satisfaction with a wider focus on support and prevention, while looking for more information.

Other revisions include increased clarity to ensure broad-based relevance in institutional and solo-based providers, an increased attention to behavior change and added examples of who can offer diabetes education, including occupational therapists and certified health education specialists. – By Samantha Costa

For more infromation:

Tomky D. #F03. Presented at: The American Association of Diabetes Educators 2012 Annual Meeting & Exhibition. August 1-4, 2012; Indianapolis.

Disclosure: Ms. Tomky and Ms. Maryniuk report no relevant financial disclosures.

Perspective

  • I attended this session so I could be as current and up-to-date with what the new standards will be forthcoming. I thought it was a great overview with realistic discussions in regard to the different organizations that I work with, and what challenges they might potentially have when it comes to interpreting the standards.

The fact that a credentialed CDE person who isn’t a nurse, dietician, or pharmacist can be in solo practice is really great. I have a lot of exercise physiology friends and I can’t wait to share that information with them. They will be so excited. They, too, are potentially masters-prepared and certified.

 

  • Source: Endocrine Today.

 

 

JUPITER trial: Benefits of statin therapy outweigh risk for diabetes.


On March 1, 2012, after experts revealed that statin therapy may increase the risk for diabetes, the FDA added a warning to all statin labels. However, new data from the JUPITER trial suggest that the benefits of statin therapy outweigh the risk for diabetes.

The Justification for Use of statins in Prevention: an Intervention Trial Evaluating Rosuvastatin (JUPITER) trial was a randomized, double-blind, placebo-controlled study of 17,603 men and women without previous cardiovascular disease (CVD) or diabetes.

Paul M. Ridker, MD, MPH, the Eugene Braunwald professor of medicine at the Harvard Medical School and director of the Center for Cardiovascular Disease Prevention, a translational research unit at the Brigham and Women’s Hospital, and colleagues sought to determine whether rosuvastatin 20 mg (Crestor, AstraZeneca) compared with placebo could decrease the rate of first-ever cardiovascular events in patients with LDL ,130 mg/dL and high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L. Focus was also emphasized on the effects of rosuvastatin on incident type 2 diabetes.

Patients were randomly assigned to rosuvastatin 20 mg or placebo and were followed for up to 5 years for the primary endpoint (MI, stroke, admission to hospital for unstable angina, arterial revascularisation or cardiovascular death), in addition to the protocol-prespecified secondary endpoints of venous thromboembolism, all-cause mortality and incident physician-reported diabetes.

According to data, patients with one or more major diabetes risk factors (n=11,508) were more likely to be female, have higher baseline BP, HbA1c, glucose, and triglycerides and lower baseline HDL cholesterol compared with those who did not have diabetes risk factors (n=6,095).

“As expected, trial participants with one or more major diabetes risk factor had an increased risk of developing diabetes during trial follow-up,” researchers wrote.

They found that, overall, incident diabetes was more apparent in the rosuvastatin group (270 reports of diabetes vs. 216 in the placebo group; HR=1.25; 95% CI, 1.05-1.49). Additional data showed that for individuals with one or more risk factors, rosuvastatin was linked to a 39% reduction in the primary endpoint (P=.0001), a 36% reduction in venous thromboembolism (P=0.15) and a 28% increase in diabetes (P=.01).

In patients with diabetes risk factors, 134 vascular events or deaths were avoided for every 54 new cases of diabetes diagnosed, researchers wrote. Those without risk factors accounted for 86 vascular events or deaths and no new cases of diabetes were diagnosed, they added.

Among patients assigned to rosuvastatin, CV benefits came with the risk for new-onset diabetes approximately 5 to 6 weeks earlier compared with those in the placebo group, researchers said. It is for this reason that Ridker and colleagues suggest further research.

In an accompanying editorial by Gerald F. Watts, DSc, PhD, DM, FRACP, FRCP, and Esther M. Ooi, PhD, from the Cardiometabolic Research Centre and Clinical Services of Royal Perth Hospital School of Medicine and Pharmacology at the University of Western Australia, said the study was intuitive and based on new evidence. However, Watts and Ooi suggest that independent data from other studies are needed to strengthen a recommendation to the FDA.

“Additionally, the question of whether or not long-term use of statins impairs glycemic control in established diabetes merits investigation, as do the precise macrovascular and microvascular consequences of statin-induced diabetes. Only robust, longer-term cohort data can address these questions,” Watts and Ooi wrote.

Disclosures: The JUPITER trial was funded by AstraZeneca. Dr. Ridker has served as a consultant for various entities, receives additional research grant support from Novartis, and holds patents held by the Brigham and Women’s Hospital which have been licensed to Siemens and AstraZeneca. Several researchers received grant support from AstraZeneca. Dr. Libby was an unpaid consultant involved in clinical trials for various pharmaceutical companies and is a member on several advisory boards. Dr. Watts has received honoraria or lecture fees from AstraZeneca and other pharmaceutical companies. All other researchers report no relevant financial disclosures.

For more information:

  • Ridker PM. Lancet. 2012; 380:565-571.
  • Watts GF, Ooi EM. Lancet. 2012; 380:541-543.
  • ClinicalTrials.gov, NCT00239681.

 

  • Source: Endocrine Today.

 

FDA approves intravitreal ranibizumab for treatment of diabetic macular edema.


The U.S. Food and Drug Administration has approved the use of once-monthly 0.3-mg intravitreal ranibizumab for the treatment of diabetic macular edema, according to a press release.

Ranibizumab (Lucentis, Genentech) is the only medicine approved by the FDA for diabetic macular edema (DME), the release said.

The 0.3-mg dose of ranibizumab was unanimously recommended for approval on July 26 by the FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee. Intravitreal ranibizumab has already been approved by the FDA for the treatment of wet age-related macular degeneration and macular edema following retinal vein occlusion.

In clinical trials, 759 patients were given a 0.3-mg dose of ranibizumab, a 0.5-mg dose of ranibizumab or a sham injection.

Patients who received the 0.3-mg dose demonstrated significant improvements in vision as soon as 7 days after treatment, with more ranibizumab-treated patients than control subjects experiencing an increase in vision of three lines or more by month 24, according to the release. Patients also experienced sustained visual acuity from baseline through 24 months, with continued treatment through 36 months.

The most common ocular adverse events associated with the 0.3-mg injection vs. the sham injection were conjunctival hemorrhage, eye pain, foreign body sensation in the eye, vitreous floaters and increased IOP.

“Diabetes is a major public health issue in our country, and all patients with diabetes are at risk of developing diabetic macular edema,” Renata Albrecht, MD, director of the Division of Transplant and Ophthalmology Products in the FDA’s Center for Drug Evaluation and Research, said in an FDA press release. “Today’s approval represents a major development for the treatment of people whose vision is impaired by DME as a complication of their disease.”

Source: Endocrine Today.

Diabetes management enhanced through successful home health care.


According to Karen A. McKnight, RD, LD, CDE, and Mary Teipen, RN, CDE, from the Indiana HomeCare Network, home health care is an effective and cost-effective option for patients with diabetes.

Using their personal experiences as home health providers, McKnight and Teipen shared insight on their home health care company, and made suggestions on how others can successfully handle the sometimes challenging feat of managing diabetes and other chronic illnesses in a home care setting.

“We all know that patients do better in their home setting, it’s a lot safer for them, there’s less risk for infection and it’s more cost-effective,” Teipen said during a presentation.

While the benefits seem obvious, Teipen said many patients and physicians aren’t even aware this form of health care is available.

“A lot of our elder Americans don’t take advantage of their home health benefit in Medicare because medical providers don’t refer them. Providers are so confused about that terminology – being ‘homebound,’” Teipen said. “Homebound doesn’t mean that you’re bedridden or that you can never leave your home. It basically means that they (patients) need assistance to leave the home, or when they do leave the home it’s a very taxing effort.”

McKnight said that one of the biggest challenges of home care is not getting patients interested in the opportunity, but reimbursement. Since 2006, McKnight said, home health reimbursement has declined by 8.5%.

“It seems each year Medicare cuts the amount that they’re paying home health, little by little. Some agencies are seeing as much as a 10% decrease, and some are seeing less, depending on certain factors. The National Association for Hospice and Home Care has estimated that this year 53% of the nation’s home care agencies will be operating at break-even or at a loss. It’s a huge issue and a big concern for those of us in this room who work in home care, in terms of what the future holds there,” McKnight said.

When coupled with deductibles and copayments that are beyond the aging patient’s budget, the impact is greater, she said.

McKnight said other issues have plagued the home health arena, despite its benefit. She and Teipen’s home health company has managed to pull through this complex area of disease management by focusing on four main specialties, one of which is diabetes due to its current trend.

“Our diabetes program is customized to meet the specialty needs of home health patients and it is very self-management education-focused for the patient and for the caregiver. In addition to that patient and caregiver focus, we have been advancing in developing the staff training component,” McKnight said.

All of their clinical staff is trained in basic diabetes patient care, Certified Diabetes Educators (CDEs) attend case conferences to discuss ever-changing complex needs of patients, and the RNs and CDEs visit the most challenging patients to develop a team approach.

Looking to the future, McKnight and Teipen said they will utilize technology at the highest level; with tele-health monitoring, video conferencing, web-based resources, physician portals, transitional care through electronic medical records and telephone patient follow-up time.

Their advice to physicians, nurses and other diabetes educators is to “just get started,” and make staff education a priority from orientation to ongoing training. Additionally, they said each home health company needs a champion with leadership and support to influence the process. Communication is the key, they said. – By Samantha Costa

Disclosure: Ms. McKnight and Teipen report no relevant financial disclosures.

For more information:

McKnight KA, Teipen M. #W20. Presented at: The American Association of Diabetes Educators 2012 Annual Meeting & Exhibition. August 1-4; Indianapolis, IN.

Perspective

  • I got into diabetes education through home care. My goal was to provide home care services to the homebound; it’s always been my first love. I really do agree with what they said – people get better when they’re in their own environment. That’s when you’re going to find out what they really have in their cupboards. Do they have the Rice Krispies or the whole wheat cereal, and so on?

With the new health care reform, I think that home care is going to become an entity that needs to be incorporated because it is cost-effective. Monies are going to have to be spent to facilitate the transition from acute care to home care, and yet still have some sort of follow-up.

So, ACOs or whatever we’re going to call them, medical homes, it’s all going to have to be related. They’re going to have to include the home care perspective. Patients appreciate it. I think the expertise that the nurses are going to have to develop is only going to increase. The diabetes field is just exploding with new products and new technologies.

    • Anne Cannon, BSN, RN, CDE
    • Senior Medical Liaison for Novo Nordisk

 

  • Source: Endocrine Today.