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FDA to Roll Out New Food Labels Focused on Caloric Intake, Sugar, and Serving Size
February 27, 2014. The US Food and Drug Administration (FDA) has announced a plan to update the Nutrition Facts label for packaged foods to reflect the latest scientific information, including the link between diet and chronic diseases such as obesity and heart disease. The proposed label will also be required to include information on the amount of added sugars and will feature a new design to highlight key parts of the label such as calories and serving sizes. The FDA is accepting public comment on the proposed changes for the next 90 days. Click here to read the full FDA press release regarding the new labeling.
FDA and European Medicines Agency Release Assessment Regarding Pancreatic Risk of GLP-1 Drugs
February 27, 2014. In an editorial in the latest issue of The New England Journal of Medicine, the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) summarize their recent collaborative effort reviewing nonclinical toxicology studies, clinical trial data, and epidemiologic data related to incretin therapies for the treatment of type 2 diabetes and pancreatic safety. The two agencies agree that a causal relationship is not consistent with currently available data, although no final conclusion can be reached at this time. Click here to read the full editorial.
Diabetes Prevention Bill Would Cut Medicare Costs, Improve Patient Health, Study Says
February 12, 2014. According to a study commissioned by the American Diabetes Association (ADA), American Medical Association (AMA), and the National Council of Young Men's Christian Association (YMCA), the proposed Medicare Diabetes Prevention Act could decrease the rate of diabetes among Medicare patients by more than one-third, as well as cut federal spending by $1.3 billion between 2015 and 2024. The bill would provide reimbursement for a group-based 16-session lifestyle intervention program, the National Diabetes Prevention Program (DPP), for Medicare recipients diagnosed with prediabetes. Click here to read the full ADA/AMA/YMCA statement.
The Health and Retirement Study 1998-2010: Association of Functional Decline With Subsequent Diabetes Incidence in US Adults Aged 51 Years and Older
February 18, 2014. This nationally representative observational follow-up study was designed to determine whether functional decline and physical disability increase diabetes risk. It included 22,878 adults tracked for an average of 8.7 years. Results suggested that individuals with any level of functional decline are at increased risk of developing diabetes (28% to 95% elevated risk). The researchers suggest that preventing disability in older adults might also reduce diabetes incidence. Follow this link to read the study abstract.
Impact of Improved Beta-Cell Function on Glycemic Variability in Patients With Early Type 2 Diabetes
February 18, 2014. The objective of this study was to determine whether short-term intensive insulin therapy (IIT), administered to improve beta-cell function in patients with early type 2 diabetes (T2DM), would also improve glycemic variability. Sixty-one patients with T2DM of 3 years’ mean duration received 4 weeks of IIT (consisting of basal insulin detemir, and premeal insulin aspart). Between the first and last week of IIT, 55.7% of patients experienced a reduction in glycemic variability. Click here to read the study abstract.
AACE/ACE to Hold International Obesity Consensus Conference
February 18, 2014. In March 2014, the American Association of Clinical Endocrinologists and American College of Endocrinology (AACE/ACE) will hold a 2-day conference in an effort to curtail and reduce the prevalence of obesity. During this conference, representatives from the physician community, public health, government, health care companies, medical research and educational communities, related medical societies and associations, and pharmaceutical companies will address the following 5 questions: 1) What is obesity? 2) What options are available for obesity management? 3) What is the optimal use of therapeutic modalities? 4) Can the optimal framework be cost effective? 5) What are the knowledge gaps and how can they be filled? Click here to read the AACE/ACE press release about this meeting.
More Than 180 Diabetes Treatments Are in the Pipeline
February 12, 2014. According to America’s biopharmaceutical research companies, more than 180 medicines are currently being developed to treat diabetes. These include 30 drugs for type 1 diabetes, 100 for type 2 diabetes, and 52 for diabetes-related conditions. Click here to read a media summary of this research.
FDA to Review Saxagliptin Heart Failure Risk
February 11, 2014. To investigate a possible association between treatment with saxagliptin and heart failure, the US Food and Drug Administration (FDA) has requested clinical trial data from the SAVOR-TIMI 53 study, published recently in the New England Journal of Medicine.
This study reported an increased heart failure–related hospitalization rate in patients treated with saxagliptin. The manufacturer is expected to submit its data to FDA by early March, after which the FDA will conduct a thorough analysis and report its findings publicly. Follow this link to read the full FDA press release and/or to submit an adverse event report for saxagliptin.
Treatment of Type 2 Diabetes in the Older Adult: A Review
February 11, 2014. A review article in this month’s issue of Endocrine Practice discusses the needs of older patients with type 2 diabetes. The authors note that older patients are a heterogeneous population with substantial comorbidities. Barriers to effective management include the lack of consensus regarding “optimal” glucose targets for older patients and elevated hypoglycemia risk (which can contribute to increased morbidity and reduced quality of life and can limit treatment decision making). Follow this link to download the full article.
ACCORD MIND Study: No Diabetes or Dementia Benefit From Blood Pressure Control or Fibrate Treatment
February 2014. This analysis of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Memory in Diabetes (MIND) trial evaluated high-risk type 2 diabetes mellitus (T2DM) patients (N=2977) with no evidence of dementia or cognitive impairment at baseline. Patients were randomized to intensive or conventional blood pressure (BP) control (<120 mm Hg or <140 mm Hg, respectively) or to treatment with fibrate vs placebo. Patient cognition was tested at baseline, 20, and 40 months. Neither BP control or fibrate therapy significantly impacted cognitive decline at 40 months, although a sub-study of total brain volume (TBV) found that intensive BP control was associated with a lower decline in TBV compared with standard treatment. Click here to read the study abstract.
Once-Weekly Albiglutide vs Once-Daily Liraglutide in Patients With Type 2 Diabetes Inadequately Controlled on Oral Drugs
February 6, 2014. This head-to-head, randomized, open-label, multicenter non-inferiority Phase 3 study compared 812 adults with inadequately controlled type 2 diabetes treated with the glucagon-like peptide-1 receptor agonists albiglutide (weekly administration) and liraglutide (daily administration). At 32 weeks, patients receiving liraglutide had greater A1C reductions than those taking albiglutide (0.99% vs 0.78%). Additionally, patients who received albiglutide had a higher rate of injection-site reactions and fewer gastrointestinal events than patients in the liraglutide group. You can review the study abstract here.
FDA Approves Pediatric Use of Dexcom’s G4 Platinum Continuous Glucose Monitoring System
February 3, 2014. The U.S. Food and Drug Administration (FDA) has approved the use of the Dexcom G4 Platinum Continuous Glucose Monitoring System for patients with diabetes aged 2 to 17 years. Previously, this device was approved only for patients aged 18 years or older. Click here to read the FDA press release.
Type 2 Diabetes Prevention: Which Approaches Work Best?
January 29, 2014. This systematic review and meta-analysis evaluated the effectiveness of different strategies to prevent type 2 diabetes mellitus (T2DM). Seventy-one controlled trials and 15 diabetes prevention strategies were included in the analysis. Evaluated interventions included diet and physical activity, specific antidiabetic and cardiovascular/lipid-lowering drugs, certain nutrients, estrogens, alcohol, and bariatric surgery. Investigators found that lifestyle and several drugs (with the exception of beta-cell stimulating drugs) were effective in preventing T2DM, with statistically significant odds ratios (ORs) ranging from 0.37 to 0.85. The most effective strategy was bariatric surgery (OR 0.16) in morbidly obese patients. Follow this link to read the study abstract.
Medicare’s Diabetes Testing Supply Program Is Limiting Patient Choice and Access
January 2014. A study conducted by the American Association of Diabetes Educators (AADE) suggests that Medicare's Competitive Bidding Program for mail-order diabetes testing supplies is limiting beneficiaries' access. Specifically, AADE contacted 23 eligible Medicare mail-order diabetes testing suppliers and found that only 3 suppliers carried each brand of diabetes testing supplies they reported having, while no suppliers had more than 50% of the product offerings listed on the Medicare website. AADE concluded that Medicare beneficiaries have reduced choice and access to diabetes testing supplies as a result of the Competitive Bidding Program. The full study report can be downloaded from the AADE website.
A1C Test Can Be Used Early to Detect Diabetes Risk
November 2013. This community-based historic cohort study followed 10,201 patients who were at high risk for, but not diagnosed with, type 2 diabetes mellitus (T2DM) at baseline. Patients’ A1C levels were measured at baseline and over the subsequent 5 to 8 years. Investigators found that A1C levels ≥5.5% were associated with increased T2DM risk and noted that these data support the use of A1C testing as a screening tool in high-risk populations. Follow this link to read the study abstract on PubMed.
Reversal of Early Abnormalities in Glucose Metabolism in Obese Youth: Results of an Intensive Lifestyle Randomized Controlled Trial
February 2014. This parallel-group, randomized controlled trial compared the impact of the Bright Bodies (BB) lifestyle program vs standard care on 2-hour oral glucose tolerance (OGTT) in adolescents with elevated OGTT at baseline. Investigators found that youth who participated in the BB program experienced significantly decreased OGTT levels (−27.2 mg/dL for BB vs −10.1 mg/dL for standard care; P = 0.005), as well as significant improvement on other markers of insulin resistance. Click here to read the full study abstract.
Severe Hypoglycemia and Cognitive Decline in Older People With Type 2 Diabetes: The Edinburgh Type 2 Diabetes Study
February 2014. Hypoglycemia may be a risk factor for age-related cognitive decline in patients with type 2 diabetes; however, the direction of this relationship is not clear. This study evaluated cognitive function in 831 adult patients (60 to 75 years of age) from the Edinburgh Type 2 Diabetes Study for self-reported historical and incident hypoglycemia, respectively, at baseline and 4 years. The authors noted that the “relationship between cognitive impairment and hypoglycemia appeared complex, with severe hypoglycemia associated with both poorer initial cognitive ability and accelerated cognitive decline.” To read the study abstract, click here.
Caffeinated and Decaffeinated Coffee Consumption and Type 2 Diabetes Risk
February 2014. This systematic review/dose-response meta-analysis included 28 prospective studies, with follow-up durations ranging from 10 months to 20 years. Investigators found that coffee consumption (caffeinated or decaffeinated) was inversely associated with type 2 diabetes risk in a dose-response manner. Click here to read the full study abstract.
Insulin Stacking vs Therapeutic Accumulation—What’s the Difference?
January-February 2014. This review clarifies the difference between inappropriate insulin stacking (wherein shorter-acting insulin formulations are used repeatedly to correct hyperglycemia, a practice that can lead to hypoglycemia) vs the appropriate accumulation of long-acting insulins dosed to steady-state pharmacokinetic profiles. To read the abstract or download the full article from Endocrine Practice, click here.
Real-World Treatment Persistence to Insulin in Type 2 Diabetes
January-February 2014. This study of 4804 patients with type 2 diabetes mellitus (T2DM; insulin glargine: 4,172, insulin detemir: 632) used pooled patient data from 3 published retrospective, observational studies to evaluate treatment persistence with initial insulin therapy. Over 1 year of follow-up, the average persistence rate was 65%. Significantly higher persistence was associated with older age, insulin glargine, and/or baseline exenatide or sitagliptin use. In addition, patients who had lower A1C levels at follow-up, greater A1C reductions from baseline, and/or less healthcare utilization had higher persistence rates. To read the abstract or download the full article from Endocrine Practice, click here.
US Preventive Services Task Force Issues Recommendations on Gestational Diabetes Testing
January 2014. The US Preventive Services Task Force (USPSTF) has released new, B-evidence level guidelines regarding screening for gestational diabetes mellitus (GDM). According to the USPSTF, all pregnant women should be screened for gestational diabetes at 24 weeks of pregnancy. These GDM recommendations align with those of the American Association of Clinical Endocrinologists, as well as several other major medical organizations. To review the current recommendations, click here; for a media summary of the USPSTF recommendations, follow this link.
FDA Approves Dapagliflozin for Type 2 Diabetes
January 8, 2014. The U.S. Food and Drug Administration (FDA) approved the sodium-glucose co-transporter 2 drug dapagliflozin (trade name Farxiga) for patients with type 2 diabetes. As part of this agreement, 5 post-marketing studies will be required to assess the impact of dapagliflozin on cardiovascular outcomes and bladder tumor risk and in pediatric patients. Additionally, a pharmacovigilance program will be established to monitor the drug’s effects on liver abnormalities and pregnancy outcomes. Click here to read the FDA press release.
FDA Issues Draft Guidance Documents for Over-the-Counter vs. Point-of-Care Glucose Monitoring
January 7, 2014. The U.S. Food and Drug Administration (FDA) released 2 draft guidance documents distinguishing between over-the-counter (OTC) and prescription point-of-care (POC) blood glucose monitoring. This represents a departure for the FDA, which previously did not distinguish between consumer and professional blood glucose monitor use. The OTC glucose monitor guidance can be downloaded here from the FDA web site, and the POC guidance is available here. In addition, this link from MedPageToday provides a brief summary of the draft guidance documents. Both documents are open for comments for 90 days.
American Diabetes Association 2014 Standards of Care Emphasize Individualized Treatment
December 31, 2013. The American Diabetes Association (ADA) released its annual Standards of Medical Care in Diabetes for 2014, with an emphasis on individualized diabetes treatment. Use this link to download the full guidelines. You can follow this link to download a slide kit summarizing the new guidelines. Additionally, a summary of revisions made to the 2014 guidelines is available at this link.
Extreme Cases of Obesity Are Up in United States
December 24, 2013. According to the U.S. Centers for Disease Control and Prevention (CDC), obesity rates among Americans overall have remained flat, but the percentage of people who are extremely obese (also known as Class 3 obesity, representing individuals with a body mass index of 40 kg/m2 or more) has increased. Specifically, the percentage of the extremely obese U.S. adult population rose from 2.8% in 1994 to 6.3% in 2010. The updated CDC weight charts can be viewed and downloaded here. You can follow this link to a media summary of this story, published by USA Today.