A new study examining individual counseling for self-care in patients with diabetes vs group education has found that the latter is associated with better outcomes. The research was carried out in a real-world situation in Ontario, with more than 75,000 patients.
"We were pleased to find that not only is group education more efficient in terms of resource utilization, it actually leads to better care and better patient outcomes, so it's a win-win situation: you can save money and improve care," senior author Baiju Shah, MD, PhD, of the Institute for Clinical Evaluative Sciences, Toronto, Ontario, told Medscape Medical News.
"There's been a little bit of clinical-trial data that compare different ways of delivering diabetes education, but there really hasn't been very much literature published in this area," Dr. Shah explained.
"So we wanted to investigate in our population cohort what the differences were, based on individual appointments vs the group-class approach, recognizing that the ministry of health and payers are pushing toward group programs because they're cheaper — you can treat more people with the same staff. We wanted to look at whether there was a clinical justification for that."
Compared with those attending individual counseling, patients who went to group classes were less likely to visit the emergency room, be hospitalized for hypo- or hyperglycemia, or develop foot ulcers/cellulitis. Group-therapy recipients were also more likely to have adequate HbA1c and lipid testing and to receive statins than those getting one-on-one care.
The research is published by Jeremiah Hwee, MSc, also of the Institute for Clinical Evaluative Sciences, and colleagues in the May/June issue of the Canadian Journal of Public Health.
Most Patients Getting Individual Care
To conduct the study, the researchers identified all patients in Ontario who attended diabetes education programs in 2006 who were grouped according to the type of program they attended. They found the vast majority of people were seen on an individual-appointment basis (n = 55,761), with fewer attending group classes (n = 12,234), and some getting a mixture of both (n = 9829).
In the following year, they compared acute complications and quality of care between the groups.
They note they were unable to distinguish type 1 from type 2 diabetes, so the analyses could not be stratified by diabetes type. "However, the overwhelming majority of patients with diabetes in the population have type 2," they observe.
Diabetes self-education is primarily provided by nurses and dieticians in Ontario, Dr. Shah explained. He said that the size of group classes "was very variable" across the population studied, although most would contain, on average, 5 to 10 patients plus family members.
"But there were some centers in smaller towns, for example, where a group program would only be run once a month, and all 50 patients in the town with diabetes would attend," he noted.
Group Education Halves Rate of Hypo-, Hyperglycemia
Compared with those attending individual counseling, patients who attended group classes were significantly less likely to have emergency-department visits for hypo-/hyperglycemia (odds ratio [OR], 0.54), hypo-/hyperglycemia hospitalizations (OR, 0.49), or foot ulcers/cellulitis (OR, 0.64) (all P < .001).
They were also more likely to receive adequate HbA1c testing (OR, 1.10; P < .001) and lipid testing (OR, 1.25; P < .001) and to get statin therapy (OR, 1.22; P = .004).
"This is the first study able to evaluate the effectiveness, not just efficacy, of group diabetes self-management education in actual clinical practice," the researchers say, noting that the benefits they observed in real-world heterogeneous clinical care "mirror those of randomized efficacy trials."
Group classes are a more efficient use of self-management education resources, because providers can deliver care to multiple patients simultaneously, Dr. Shah noted.
Asked if he had theories as to why the group classes had better clinical outcomes, he said: "We were using secondary data, so we didn't have direct access to patients, but other studies that have been published suggest visits tend to be longer — a full day or a half day compared with 20 minutes or half an hour [for individual counseling] — so there is certainly more time spent."
Previous research has also shown that information received from group classes is rated as more "useful" by patients than that received at individual counseling, he said. This likely includes the importance of discussing feelings with others with diabetes.
"Developing that sense of community and talking to others with the same experience and being able to share stories does have some value," he said.
Yet fewer than 1 in 7 self-management education program attendees in Ontario went to group classes, Dr. Shah noted.
"In a time of increasing pressure to find efficiencies in healthcare delivery…the finding that [group classes] reduce acute complications and improve quality of care suggests that they should be the preferred method of delivering self-management [diabetes] education support where it is feasible to do so," he and his colleagues conclude.
The authors have reported no relevant financial relationships.
Can J Public Health. 2004;105: e192-e197. Abstract
Healthcare organizations turn to technology to reduce the far-reaching, costly impact of diabetes.
Written by Alison Diana
Healthcare providers, payers, and patients expect new technologies and shifts to patient engagement and population health will help the nation's 29.1 million diabetics manage their condition and reduce the costs associated with this dangerous and expensive disease.
In 2012, diagnosed diabetes cost the US $176 billion, and reduced productivity cost another $69 billion, according to the Centers for Disease Control. After adjusting for age and gender differences, average medical expenses for people with diabetes were 2.3 times higher than they would have been without diabetes, the American Diabetes Association reported.
More than 1.5 million Americans have Type 1 diabetes; the vast majority of cases are Type 2 diabetes, which typically is linked to obesity. In Type 2 cases, patients still produce insulin and may improve with lifestyle and diet changes. Unchecked, diabetes can lead to more medical complications and even death.
Without attention, US diabetes cases will increase, fueled by Americans' diet of sugar and processed food, Dr. Brett Osborn, author of Get Serious: A Neurosurgeon's Guide to Optimal Health and Fitness, told InformationWeek.
"More than 30% of Medicare dollars are spent on diabetics and/or related complications. Likely diabetes, or more specifically 'insulin resistance,' will be linked to many more disease processes -- i.e., Alzheimer's disease is also referred to as 'Type III diabetes,' as one of its underpinnings is insulin resistance," he says.
In an effort to improve health, reduce costs, and slow down future cases, healthcare providers are educating non-diabetics about how to avoid the condition and using new and long-established tools to help diabetics live healthier lives.
They're influenced by healthcare's transition to patient engagement -- with its growing reliance on patient portals, mobile apps, and the creation of health-focused communities -- plus population health, which considers the multiple factors that make up the population's individual and overall health.
In Cities for Life, a diabetes management program supported by Sanofi US and conducted by the American Academy of Family Physicians Foundation, patients were connected with community resources to help manage their condition. Partners at the University of Alabama researched resources at local churches, YMCAs, gyms, and other sites, then created a database and website -- MyDiabetesConnect.com -- where residents could locate farmers' markets, exercise programs, and other items conducive to health living.
"Obviously what happens in their doctors' offices is very important, but they need to carry out what they plan in their doctors' offices throughout the year," Dr. Edwin Fisher, global director of Peers for Progress at the American Academy of Family Physicians Foundation, tells us. "We really need comprehensive approaches that bring together clinical care, community care, social support, friends, and neighbors, to help people with diabetes live their lives well and take care of their diabetes well."
Increasingly, that care involves technology.
The information pouring in from glucose meters provides developers, researchers, payers, and other members of the healthcare world with a plethora of data for analysis that could provide insight into new treatments or devices. Tens of thousands of diabetics also use the more than 1,000 apps now available to monitor and manage the condition, further fueling both improved health and big-data solutions.
"Ultimately, more aggressive monitoring -- implantable, continuous -- will lead to tighter glucose control. This equates to reduced formation of advanced glycation products and lower bodily inflammation (the damaging, diabetes-associated epiphenomena)," says Osborn. "Google will likely be introducing a contact lens-based glucose monitor in the next several years. This will allow for real-time monitoring of blood glucose, essentially providing a number upon which people can rapidly act. Aggressive treatment early on is the key -- although prevention obviously is ideal."
Tech companies are venturing into the diagnostics and treatment market. Patients can use smartphones to monitor their condition. In addition to Google's under-development smart contact lens, other companies are creating a bionic pancreas and exploring genomes to control diabetes.
Take a look at some of the technologies currently in use, and let us know what your organization is doing to help diabetic patients control costs and improve their health.
Earlier this year, Google took the wraps off its smart contact lens project, "built to measure glucose levels in tears via a tiny wireless chip and miniaturized glucose sensor embedded between two layers of soft contact lens material." The developer also is investigating whether integrated LED lights could show when glucose levels have passed above or below particular thresholds.
"We're in discussions with the FDA, but there's still a lot more work to do to turn this technology into a system that people can use. We're not going to do this alone: we plan to look for partners who are experts in bringing products like this to market," wrote project co-founders Brian Otis and Babak Parviz on Google's blog. "These partners will use our technology for a smart contact lens and develop apps that would make the measurements available to the wearer and their doctor."
Engineers from Boston University created a closed-loop bionic pancreas system that uses continuous glucose monitoring and subcutaneous delivery of rapid-acting insulin and glucagen as directed by an algorithm. The system, currently being tested on people with Type 1 diabetes at Massachusetts General Hospital, could one day make automated blood glucose control a reality, according to the developers' blog.
The manmade pancreas makes a new decision about insulin and glucagen doses every five minutes. Previous bionic pancreases could not administer glucagen, which raises blood glucose in response to hypoglycemia.
"Achieving and maintaining near-normal blood glucose concentrations are critical for the long-term health of people with diabetes. Unfortunately, the therapy required to achieve this goal is extremely demanding, requiring frequent blood glucose checks and either multiple daily insulin injections or the use of an insulin pump," the researchers wrote. "Even with current state-of-the-art insulin replacement, it is almost impossible to completely avoid hyperglycemia and hypoglycemia."
Improving Medication Adherence
The Accountable Care Organization of Greater New York (ACCGNY) and AllazoHealth are partnering on a pilot aimed at improving medication adherence among ACCGNY's Medicare-eligible beneficiaries. Many people in this group are elderly and/or have intellectual and developmental disabilities, and many have multiple conditions, including diabetes, hypertension, epilepsy, and/or hyperlipidemia. The pilot, sponsored by a grant of $91,914 from 2014 Pilot Health Tech NYC, will use AllazoHealth's AllazoEngine to determine which patients are most at risk of not taking their prescribed medications and to predict which interventions are most likely to promote adherence.
Clinical staff will use the results from AllazoEngine to deliver patients' interventions via calls or in-person counseling. The analytics engine bases its results on ACCGNY's historical claims data. In addition to reducing medical costs, the pilot should improve care for IDD patients.
"Our goal is to provide affordable, high quality care to our Medicare beneficiaries. Partnering with AllazoHealth will give us the tools to improve our population's medication adherence and reduce medical costs," said Gabriel Luft, executive director of ACCGNY, in a statement
Former American Idol judge Randy Jackson teamed up with digital health and wellness company Everyday Health to create consumer-facing resources about diabetes on a platform dubbed "Diabetes Step by Step." Jackson will provide blogs, videos, and a diabetes awareness-screening program, slated to run live in a number of cities through November -- American Diabetes Month.
Jackson, who was diagnosed with Type 2 diabetes in 1999, wrote about his experiences in Body With Soul: Slash Sugar, Cut Cholesterol, and Get a Jump on Your Best Health Ever. He also has served as the spokesman for the American Heart Association's "Heart of Diabetes" campaign. "Diabetes is an issue that is near and dear to my heart, and this is a tremendous opportunity to educate people on diabetes prevention and control," Jackson said in a statement.
Once big, bulky machines, glucose monitors are now as sleek as an iPhone. Vendors like Gmate integrate an app and smart meter that connects to the iPhone headphone jack, then measures a patient's blood glucose reading.
The Gmate Smart is compatible with Apple's iPhone 3GS, 4, 4S, and 5; the iPod Touch 4th generation; plus iPad and iPad 2. Users download the app from iTunes, insert Gmate's smart device and test strip, apply the sample, and see their results on the Apple device screen.
Researchers, payers, and providers are exploring the connections between a host of potential causes and effects on diabetics thanks to powerful, lower-cost, and user-friendly big-data and analytics tools. The move to collapse silos and combine multiple research studies to seek trends from greater pools of subjects is generating pilot programs, reallocation of resources, and additional benefits.
Startup Databetes, founded by a person with Type 1 diabetes, uses a data-driven approach to diabetes management that combines apps and smartphones, as well as food and lifestyle data, to help patients manage the condition. Explorys and Accenture are collaborating on an initiative to improve population health approaches for diabetes care.
There are more than 1,100 iOS and Android apps designed expressly to help people manage diabetes. They include cookbooks and a wide array of management apps that help diabetics track their insulin, exercise, and sugar intake.
Glooko, for example, allows patients to download blood glucose readings to their smartphones, integrate food and lifestyle data, then share that information with health providers. Glooko also makes available diabetes-related data and analytics to healthcare providers and payers to support research into the condition. Diabetes Pilot records glucose, insulin, and other measurements; tracks food nutrients; includes a food database; and allows patients to share data with healthcare providers. And GlucoseBuddy, for iOS, lets users record meals, exercise, insulin levels, and share records with physicians.
As part of the 2013 Data Design Diabetes Sanofi US Innovation Challenge, Common Sensing developed GoCap, a pen cap that tracks insulin and wirelessly connects with a smartphone. A replacement cap for insulin pens, the GoCap reads insulin amounts and times, then communicates via Bluetooth with a phone or connected glucometer, HIT Consultant reported.
Developers offer several tools for people who look after individuals with diabetes, as well as patients themselves. Developers such as Dexcom, Medtronic, Glucose Buddy, and American Association of Diabetes Educators offer apps filled with training, education, and other items of use for caregivers.
Telemedicine can help diabetics save time and money, and can help healthcare systems improve population health and profitability.
For example, the University of Mississippi Medical Center, North Sunflower Medical Center, GE Healthcare, Intel-GE Care Innovations, and C-Spire formed the Diabetes Telehealth Network -- an 18-month remote care management program to serve the region's high percentage of diabetic patients. Harvard's Joslin Diabetes Center and American Well teamed up to provide telehealth services to diabetics nationwide
Diabetes breakthrough drug can work for two days from a single jab
By Andrew Gregory
Scientists say the two-day diabetes jab will help millions and tests have found no side
A jab that can reverse diabetes for up to two days has been developed by scientists.
One injection of the groundbreaking drug brings blood sugar levels back to normal and restores sensitivity to insulin.
More than three million people suffer from the condition in the UK.
US researchers tested the drug – FGF1 – on mice and were stunned by the “dramatic” results.
The next stage will be clinical trials on patients.
At the moment diabetes can only be managed through diet, exercise and conventional drugs, which work by reversing insulin resistance.
But these drugs can cause sugar levels to dip and spark potentially life-threatening hypoglycaemia.
They also carry risks of weight gain, and heart or liver problems.
But even at high doses, researchers found that FGF1 does not trigger these side effects.
Dr Michael Downes, co-author of the study published in the US medical journal Nature, said: “Many previous studies that injected FGF1 showed no effect on healthy mice. However, when we injected it into a diabetic mouse, we saw a dramatic improvement in glucose.”
Diabetes is a growing problem in the UK, with 163,000 new cases diagnosed last year – the biggest annual increase since 2008.
It means 6% of UK adults are registered as diabetic. Experts believe another 850,000 may have the condition but don’t know it.
Diabetes UK says the rise is largely fuelled by type 2 diabetes, linked to obesity and a unhealthy lifestyle.
Being overweight raises the risk of not producing enough insulin, or cells failing to react to insulin, which controls the amount of energy-giving glucose in the blood.
Dr Ronald Evans, professor at the Salk Institute in La Jolla, California, said: “Controlling glucose is a major problem in our society. FGF1 offers a new method of controlling it in a powerful and unexpected way.”
By Naomi Kresge
Older Germans who took Takeda Pharmaceutical Co. (4502)’s diabetes medicine Actos were slightly less likely to develop dementia, according to a study that may do little to resolve questions about the drug’s usefulness.
The German Center for Neurodegenerative Diseases followed 145,717 people of age 60 or older who were members of the country’s biggest public insurer from 2004 to 2010, tracking whether they developed dementia and also whether they took Actos, once the world’s best-selling diabetes medicine. Those on the drug were 6 percent less likely to develop dementia, according to results presented today at the Alzheimer’s Association International Conference in Copenhagen.
Doctors have long wondered whether Actos, known generically as pioglitazone, and another similar diabetes drug, Avandia, or rosiglitazone, might also work in the brain to stave off dementia. An Alzheimer’s study of Avandia failed, and problems with side effects plagued both drugs. Now Takeda is trying again with Alzheimer’s, in a five-year trial that started last August. Today’s data may not provide much encouragement, said Ben Wolozin, a professor at the Boston University Alzheimer’s Disease Center.
“It was very important to do this study,” Wolozin said in a telephone interview. “However, it’s actually almost surprising to me that the lowering of relative risk was so weak.” The 6 percent reduction seen in the study is such a small effect that it’s unlikely to translate into an observable difference in everyday practice, Wolozin said.
Even so, he said, Takeda is probably right to continue the study begun last year. Takeda’s study, dubbed Tommorrow, will compare pioglitazone with placebo tablets and will also see whether a genetic test can predict which patients are at risk of developing mild cognitive impairment due to Alzheimer’s.
“The benefits of a success are huge,” Wolozin said.
Takeda said its trial will probably keep enrolling patients for the next several months before it hits a target of 5,800 people. It’s on schedule, Stephan Brannan, the Osaka-based company’s head of central nervous system development, said by e-mail before today’s research was released.
The German research team declined to comment in advance of the study’s publication.
To contact the reporter on this story: Naomi Kresge in Berlin at email@example.com
To contact the editors responsible for this story: Phil Serafino at firstname.lastname@example.org
Diabetes is a disease cause due to metabolic disorders in human body. Inadequate insulin production in human body may be the cause of this disease. Secondly, Human body cells may not respond properly to insulin. A diabetic patient can have both the problems. Obesity is a major risk factor for everyone. Obese people are among the first liners for diabetes risk.
Diabetes can be under control or may be prevented with the aid of Few Exercises at Home combine with proper clinical guidance.
A new study suggests that the most effective way for people with type 2 diabetes to control their blood sugar levels with exercise is by combining aerobic exercises with resistance training.
Previous studies have shown the benefits of aerobic exercises, such as jogging and swimming, and resistance training (muscle strengthening or toning exercises) for people with or at high risk of type 2 diabetes.
Experts from the University of Vienna studied the effect of aerobic exercise, resistance exercise and combination of both to a human’s blood sugar control, blood pressure and blood fats.Aerobic exercise include swimming and jogging while resistance or strength exercises are mainly weight lifting and using other gym weight machines.
Published on July 2 in the journal Diabetologia, the research contains data from 14 studies that include 915 people with type 2 Diabetes and looked into the role of aerobic and strength exercises in enhancing the health of diabetics.
Findings indicate that combining the two types of exercise was more effective in controlling blood sugar, blood fats, blood pressure and weight, and even helped more people attain higher levels of good cholesterol.
Exercise is always a good choice for people battling type 2 diabetes.
“Both aerobic and resistance activity are capable of reducing blood glucose,” Dr. Gerald Bernstein, director of the Diabetes Management Program at the Friedman Diabetes Institute, part of Beth Israel Medical Center in New York City, explained.
He further added that different modes of exercise have different effects.
To date, no systematic review has compared the direct and indirect effects of these three different training modalities on the outcomes of blood sugar control and blood fats in patients with type 2 diabetes. The aim of the present study was to assess the efficacy of aerobic exercise training (AET), resistance training (RT) and combined training (CT) on blood sugar control, blood pressure and blood fats in patients with type 2 diabetes in a systematic review and meta-analysis.
A total of 14 trials enrolling 915 participants were included. The results showed that, in patients with established diabetes, AET might be more effective in reducing HbA1c (a measure of blood sugar control) and fasting glucose when compared with RT. CT was more powerful in reducing HbA1c compared with AET, and more effective in reducing HbA1c, fasting blood glucose and blood fats when compared with RT. However, these results could not be confirmed when only low risk of bias studies were included. Pooling both direct and indirect evidence on AET, RT and CT via meta-analysis demonstrated that CT was the most efficacious exercise intervention regarding its impact on HbA1c, fasting glucose, good cholesterol, blood fats, diastolic blood pressure and bodyweight.
The authors note that only studies where the training was supervised (and thus objectively validated) were included in the analysis. There is evidence that supervised exercise is more effective than unsupervised training, but in practice it seems unlikely that most patients would have access to supervised exercise regimens of this intensity.
The authors say, “It is possible that either AET, RT or CT may be easier to perform effectively without supervision, thus affecting the external validity of these results since only studies with supervised training were included
By Kathryn Doyle
(Reuters Health) - Black and Asian adults may be at risk for developing diabetes at a lower weight than whites, according to a new study.
Based on the findings, researchers suggest the definition of obesity should be different for different populations, in order to trigger diabetes interventions in a timely manner.
Body mass index (BMI) is a measure of weight in relation to height used to assess health risks. The Centers for Disease Control and Prevention (CDC) defines overweight as a BMI of 25 to 29.9 and obesity as a BMI of 30 and above.
However, those cutoffs are primarily applicable to white people, which has been noted by the World Health Organization (WHO), Dr. Naveed Sattar told Reuters Health.
“But few people really recognize this,” he said. Institutions like the WHO and CDC have yet to adopt ethnicity-specific BMI cutoffs for overweight and obesity.
Sattar worked on the study at the Institute of Cardiovascular and Medical Sciences at the University of Glasgow in the UK.
He and his team analyzed data on almost 500,000 middle-aged UK adults, 96 percent of whom were white. The remaining four percent included South Asian, black and Chinese adults.
Five percent of the total group, or about 25,000 people, had diabetes, according to findings published in Diabetes Care.
Compared to whites, nonwhite adults were at least twice as likely to have diabetes. Diabetes rates for white people with a BMI of 30, the lower threshold for obesity, were equal to diabetes rates for South Asians with a BMI of 22, black people with a BMI of 24, Chinese women with a BMI of 24 and Chinese men with a BMI of 26.
Results were similar when the researchers looked at waist circumference: nonwhite people were at risk for diabetes at smaller waist sizes than white people.
In 2013, the National Institute for Health and Care Excellence (NICE) in the UK recommended new BMI thresholds for intervening to prevent ill health among ethnic minorities including people of African, Caribbean and Asian descent. The group indicated an increased risk of chronic conditions at a BMI of 23 or higher and a high risk of chronic conditions starting at a BMI of 27 for those people.
“The guidance and briefing documents make recommendations for health services and local government to take action,” Dr. Tonya Gillis, media relations manager for NICE, told Reuters Health by email. She noted that NICE public health guidance only applies to England and not to international standards.
Researchers have suggested that a combination of genetic and environmental factors play a role in different body fat patterns by ethnicity, but questions remain.
The new study and others suggest that the obesity cutoff for Asians in particular might need to be reevaluated, Sattar said.
The report included many people but only addressed one point in time, he noted. These findings need to be verified by another study that follows a group of people over time, he said.
Establishing ethnicity-specific cutoffs for obesity is important partly to make doctors aware that diabetes risk can be heightened at much lower BMIs for some ethnicities, which should prompt them to give lifestyle advice and screen for diabetes at lower weights, Sattar said.
“If any population of people are at an increased risk of developing a range of serious conditions, then it’s vital to highlight any relevant risk factors that can help professionals and the individuals affected to take action at the earliest opportunity,” Gillis said.
7/9/2014 4:15 PM ET
Those who are extremely obese, i.e. with a BMI above 40, die much earlier than their less obese counterparts, according to research conducted at the National Cancer Institute. The meta-study, published in the journal PLOS Medicine, found that those carrying at least 100 pounds over their ideal weight die 6.5 to 13.7 years sooner than those with healthy weights.
BMI is calculated by dividing weight in kilograms divided by the square of height in meters. Obesity is a BMI of 30 or higher (180 lbs at 5 feet 5 inches), while extreme obesity is 40 or higher, i.e. 241 lbs at the same height. Those who are extremely obese typically need to lose 100 lbs or more to attain a healthy weight. About six percent of American adults are extremely overweight.
"If current global trends in obesity continue, we must expect to see substantially increased rates of mortality due to these major causes of death, as well as increasing healthcare costs," the authors of the study said.
The Food and Drug Administration on Friday approved a long-delayed inhalable diabetes medication to help patients control their blood sugar levels during meals.
The FDA cleared MannKind Corp.'s Afrezza, a fast-acting form of insulin, for adults with the most common form of diabetes, which affects more than 25 million Americans. The approval decision comes more than three years after the agency first asked MannKind to run additional clinical studies on the drug.
Demand for diabetes treatments is surging globally as the prevalence of obesity explodes. According to the World Health Organization, roughly 347 million people worldwide have the disease, a chronic condition in which the body either does not make enough insulin to break down the sugar in foods or uses insulin inefficiently. It can lead to blindness, strokes, heart disease or death. In type 2 diabetes, the most common form of the disease, the body does not use insulin properly. Type 1 diabetes is usually diagnosed in children and young adults. In those cases, the body does not produce insulin.
Afrezza, an insulin powder, comes in a single-use cartridge and is designed to be inhaled at the start of a meal or within 20 minutes. MannKind has said that patients using the drug can achieve peak insulin levels within 12 to 15 minutes. That compares to a wait time of an hour and a half or more after patients inject insulin.
The FDA said in its approval announcement that Afrezza is not a substitute for long-acting insulin and is a new option for controlling insulin levels during meals. The agency approved Afrezza with a boxed warning — the strongest type — indicating that the drug should not be used in patients with chronic lung diseases, such as asthma and smoker's cough, due to reports of breathing spasms. The agency is also requiring several follow-up studies looking at the drug's long-term safety, including its impact on the heart and lungs.
Mannkind first submitted the drug to FDA in March 2009. The Valencia, California-based company has no other products on the market and lost more than $191 million last year.
Several other companies have failed to make inhaled insulin work commercially. In 2007, Pfizer Inc. discontinued its inhaled insulin Exubera after it failed to gain ground on the market. In 2008, Eli Lilly & Co. ended its development program, citing regulatory uncertainty.
MannKind shares fell 5.5 percent in regular trading after the FDA's approval announcement but rebounded 70 cents, or 7 percent, to $10.70 in after-hours trading Friday.
Researcher wants gender-based treatment; failure of women to lower LDL cholesterol means more risk for cardiovascular death
June 24, 2014 – A study of senior men and women with Type 2 diabetes, who were fighting to lower their cholesterol with statins, has found that women are much less likely to lower their bad cholesterol, or low-density lipoprotein (LDL) cholesterol. The research leader is calling for gender-based treatment to lower the risk of cardiovascular death in women.
With treatment, only 64 per cent of women lowered their LDL cholesterol to the recommended level compared with 81 per cent of men, the investigators reported.
“The findings suggest the need for gender-based evaluation and treatment of cardiovascular risk factors in these patients,” says Dr. Pendar Farahani.
“We need further study into the gender disparities to tailor drug interventions and we need to increase the inclusion of women in clinical trials.”
Dr. Farahani is an assistant professor in the Department of Medicine and Department of Public Health Sciences at Queen’s University in Kingston, Ontario, Canada.
This study demonstrated women with diabetes are more likely than men to have a LDL-C above treatment goals, according to the study. However, this pattern of gender gap was not observed for HgbA1c goal attainment. It did conclude that the concept of gender gap is useful for identifying at-risk groups for prevention and treatment efforts.
Research has also shown women have poorer adherence to taking their statin medication to treat high cholesterol, perhaps due to somewhat dissimilar pharmacological properties in a woman’s body than a man’s. For example, women often have more side effects such as muscle pain, explains Dr. Farahani.
“The finding that women were not able to lower their so-called bad cholesterol sufficiently is a concern,” he says. “Women with diabetes have a considerably higher rate of cardiovascular-related illness and death than men with diabetes. This pattern is likely related to poorer control of cardiovascular risk factors.”
Dr. Farahani’s research also discovered access to medication is not responsible for this difference. All patients, who were in a database from pharmacies in four Canadian provinces, had social insurance and were able to afford their medications.
To evaluate whether biological sex influenced the results of cholesterol-lowering drug treatment, Dr. Farahani included nearly equal numbers of men and women (101 and 97) in the study.
The average age of participants was 65 years for men and 63 years for women. All patients had Type 2 diabetes and had filled prescriptions for statin medication to treat high cholesterol between 2003 and 2004.
The results were presented on Saturday at the joint meeting of the International Society of Endocrinology and The Endocrine Society: ICE/ENDO 2014 in Chicago.
Original report by Anne Craig, Communications Officer, Queen’s University
Researchers have long understood there is a strong association between diabetes and depression. But new research presented at the American Diabetes Association's 74th Scientific Sessions shows that symptoms of depression in people with type 2 diabetes can be significantly reduced through interventions for "diabetes distress," suggesting that much of what is being labeled as depression may not be a co-morbid psychiatric disorder after all, but rather a reaction to living with a stressful, complex disease that is often difficult to manage.
A second study, of patients with type 1 diabetes, emphasizes the potential importance of treating depressive symptoms regardless of their cause: It found that the greater depressive symptoms a patient reported, the higher that person's mortality risk.
Diabetes distress v. depression
"Because depression is measured with scales that are symptom-based and not tied to cause, in many cases these symptoms may actually reflect the distress that people are having about their diabetes, and not a clinical diagnosis of depression," said lead author Lawrence Fisher, PhD, ABPP, Professor of Family and Community Medicine at the University of California, San Francisco.
Fisher and his team developed measures of diabetes-specific distress that reflect whether a person had been feeling worried about a variety of problems associated with living with their diabetes, such as hypoglycemia. They also asked patients to fill out the Patient Health Questionnaire to measure depressive symptoms. Those who reported high levels of distress and high levels of depressive symptoms were assigned one of three interventions, all of which were designed to reduce the distress associated with managing diabetes, rather than symptoms of depression.
One group took part in an online diabetes self-management program. A second participated in the online program, and received individual assistance to problem solve issues related to their diabetes distress. A third was provided with personalized health risk information and then sent educational material about diabetes through the mail. All groups received personal phone calls during the course of the project.
All three interventions significantly reduced distress as well as depressive symptoms over a 12-month period, and patients maintained those reductions over the course of the study. Overall, 84 percent of those scoring above 10 on the PHQ8 (maximum 27, with 10 being moderate depression) reduced their levels of depression to below 10 following the interventions, Fisher said. Reductions were evenly distributed for all three interventions.
"What's important about this," said Fisher, "is that many of the depressive symptoms reported by people with type 2 diabetes are really related to their diabetes, and don't have to be considered psychopathology. So they can be addressed as part of the spectrum of the experience of diabetes and dealt with by their diabetes care team."
Depressive symptoms associated with higher mortality
A second, unrelated study that analyzed data from a cohort of people with type 1 diabetes in the Pittsburgh area, the Pittsburgh Epidemiology of Diabetes Complications study (EDC), showed why it is so important to recognize depressive symptoms in people living with diabetes: Those who exhibit the highest level of depressive symptoms are most likely to die prematurely.
In this study, the Beck Depression Inventory was used to measure depressive symptoms such as low mood, losing interest in doing things, loss of appetite, feeling worthless and having suicidal tendencies. Participants in the study had been diagnosed with diabetes as children between 1950 and 1980, and were first studied in 1986. They are now in their 25th year of follow-up as part of a large, prospective cohort study.
"For every 1-point increase on the Beck Depression Inventory scale, participants showed a 4-percent increase in risk for mortality – after controlling for other factors that might increase the risk of death," said Cassie Fickley, the lead author who analyzed these data as part of her PhD degree.
"These data are very consistent with earlier findings from EDC which showed that greater depressive symptomatology predicted the incidence of heart disease in this cohort," said Trevor Orchard, MD, M.Med.Sci., FAHA, FACE, Professor of Epidemiology, Medicine and Pediatrics at the Graduate School of Public Health, University of Pittsburgh, and the EDC study principal investigator.
The earlier analysis was conducted by Cathy Lloyd, PhD, a co-author on the current paper, and currently a senior lecturer at the Open University in the UK. Lloyd noted that "the data are relatively unique as the consequences of depression in type 1 diabetes are an understudied area of research."