Day 2 highlights: Saturday 10th June
medwireNews: Symposia on the second day of the 2017 American Diabetes Association 77th Scientific Sessions focused on topics ranging from the mechanistic links between cancer, obesity, and diabetes to novel islet signaling pathways and dealing with the rising costs of insulin.
Hyperbaric oxygen therapy for diabetic foot ulcers: Fact or fiction?
In this session, William Tettelbach (Intermountain Healthcare, Salt Lake City, Utah, USA) and Andrew Boulton (University of Manchester, UK) debated the merits of hyperbaric oxygen (HBO2) treatment in diabetic foot ulcers (DFUs).
Arguing in favor, Tettelbach immediately discredited two trials that concluded that HBO does not work for DFUs, saying that they were flawed because they included Wagner type 2 DFUs, which are known not to benefit from HBO2 treatment. He also noted that the sham treatment groups still received around 27% oxygen at treatment pressure, versus 100% in the intervention group, meaning that the studies were looking at variable dosing rather than being placebo controlled. However, he said that studies that did not use sham comparators showed improved healing with HBO2.
Tettelbach added that the benefits of HBO2 therapy include direct suppression of anaerobes, promotion of angiogenesis, and restoration of oxygen tension to above 30 mmHg, which allows neutrophils and macrophages to undergo oxidative burst.
Nonetheless, he admitted that there is a need for a more sophisticated criteria base for selecting patients eligible for HBO2 therapy and said that the current practice of delaying treatment by 30 days should be reconsidered as it can negatively affect outcomes. In addition he suggested that treating wounds until closure may be ineffective and drive up costs when wound care specialists can take over after initial HBO2 treatment.
Boulton followed with a passionate and amusing presentation arguing strongly against the use of HBO2 in the treatment of DFUs. He said that he witnessed the same debate at ADA 10 years ago and not much has changed since then, adding that HBO2 treatment is “mired in a long history of quackery.”
His main argument was that there is not enough evidence to demonstrate the efficacy and justify the use of HBO2 in DFUs when more effective, less expensive treatments already exist.
He highlighted several clinical trials and reviews, including the Dutch DAMOCLES trial, which showed that HBO2 did not significantly improve wound healing.
Boulton concluded that although he would like to believe it is fact that HBO2 is effective in the treatment of DFUs, “to date there is little evidence to support [this].”
Overtreatment and individualized care in type 2 diabetes
There were four presentations in a session on overtreatment in type 2 diabetes, all of which reiterated the fact that frail elderly patients are particularly susceptible as discussed in yesterday’s highlights report.
However, Rozalina McCoy (Mayo Clinic, Rochester, Minnesota, USA) pointed out that we should not confuse overtreatment with intensive glucose control. She explained that overtreatment happens when the risks of treatment outweigh the benefits, whereas intensive control is doing what it takes to lower glycated hemoglobin (HbA1c).
McCoy added that the harms of overtreatment include cost, polypharmacy, increased burden, and side effects. She also highlighted that patients’ concerns about increased treatment burden are not being recorded in their clinical notes, which suggests that “we really underestimate the burden of treatment in patients,” she said.
Drivers of overtreatment include the perception that more is better, with clinicians overestimating the benefits of glycemic control and underestimating the risk for hypoglycemia. Pressures of performance measurement, clinical inertia, concerns about legal liability, and time limitations also play a part, and McCoy concluded: “No drug is safe when it’s a burden.”
Elbert Huang (The University of Chicago, Illinois, USA) pointed out that these drivers of overtreatment are also barriers to personalized, patient-centered diabetes care, and despite the numerous performance measures that clinicians must adhere to, he said there is no way to reward high-quality individualized care.
“Overall the failure to personalize care is real,” Huang remarked, adding that shared decision-making is one approach to encourage treatment personalization as it consistently reduces decisional conflict. But he cautioned that it may not direct decisions in specific ways.
Another way that personalized diabetes management can be affected is through the heterogeneity of treatment effects (HTE), reported Sanjeep Vijan, from the University of Michigan in Ann Arbor, USA. He explained that HTE refers to the fact that not all patients will benefit from a treatment judged beneficial in a trial because treatments are not universally effective.
Vijan also advocated the shared decision-making approach– asking patients how much benefit is enough for them and looking at how to design a treatment regimen that maximizes benefits and minimizes burdens – is important for the prevention of overtreatment, he said.
Also speaking in the session was Deborah Wexler from Massachusetts General Hospital in Boston, USA. She talked about four specific patient groups that can benefit from individualized treatment: those with cardiovascular disease; non-alcoholic fatty liver disease; patients with high insulin requirements; and those at risk for hypoglycemia.
This last group was particularly interesting because, as well as including frailty and cognitive impairment, which are well-known risk factors for hypoglycemia, Wexler also mentioned food insecurity as a risk. She explained that it is very common for people to run out of money at the end of the month and therefore have inadequate food intake without adjusting their sulfonylurea dose, which can result in hospital admissions for hypoglycemia.
Wexler concluded that the ADA Standards of Care is a useful framework to use when individualizing treatment.
Expansion of the Diabetes Prevention Program – perspectives from early adopters
One of the last sessions on day 2 focused on the implementation of the US National Diabetes Prevention Program (NDPP), which is currently undergoing expansion to cover the whole of the United States of America by January 2018.
Nina Brown-Ashford, from the US Centers for Medicare and Medicaid Services in Baltimore, Maryland, who administer the program, explained that the NDPP offers 16 core diet and exercise sessions to all Medicare part B beneficiaries with a body mass index above 25 kg/m2, a laboratory-confirmed raised fasting blood glucose level, and no history of type 1 or 2 diabetes.
The sessions take place over 6 months and are followed by monthly maintenance sessions for a further 6 months, which can continue up to 2 years for patients who maintain their weight loss.
Brown-Ashford went on to discuss the criteria that organizations, including virtual service providers, will need to meet in order to enroll as NDPP suppliers and urged them to begin the process now so that they are ready when the national expansion goes live.
In response to a question from an audience member concerned about the future of the Affordable Care Act (ACA), Brown-Ashford said that reimbursement for the NDPP comes from a different funding source not tied to the ACA, and will therefore be unaffected.
In the next presentation, Nicole Johnson, from the University of South Florida in Tampa, USA, offered advice on how to identify and overcome barriers to patient enrollment in the NDPP. She said that a good “social marketing” approach was key, but stressed that before you can enroll patients, organizations must be on board.
Once they are, they will need help in recruiting and retaining users and Johnson made a number of suggestions, including:
- Tapping in to community champions and natural connectors
- Using local celebrities to increase social acceptance
- Hosting local events to raise awareness
- Celebrating success with a party to increase social engagement
Following on from Johnson, Dorothy Ghodes (Montana Department of Public Health and Human Services, Helena, USA) and Linda Weiss (The New York Academy of Medicine, USA) discussed their experiences of rolling out the NDPP in Montana and New York, respectively.
Ghodes said her team found that group size did not affect participation or outcome; their weekly education and exercise classes had between eight and 34 participants, but outcomes were similar regardless. By contrast, age was an important determinant of participation, with over 65s attending more sessions than younger patients.
Ghodes also reported that telehealth played a key role in the success of the NDPP in Montana as it allowed individuals in remote communities who would not normally have access to the program to benefit.
The biggest problem that Weiss and her team in New York faced was the recruitment of men. Despite developing a male-led tailor-made program, just 29 men signed up, even with large-scale promotion.
By contrast, she found that offering programs “where people are,” such as at work or in a faith-based environment had excellent engagement, with an attendance rate of 95% and average weight loss of 5.4% reported in one work-based program.
Weiss also said that scheduling and logistics, ie, not wanting to drive to a class at night in winter, illness and comorbidity, dissatisfaction with the curriculum, and having other priorities and potential problems, are common reasons for dropping out of the NDPP. The users reporting these problems suggested that increased outreach from coaches to encourage reengagement and practical tools to facilitate change, such as recipe cards, might improve attendance.
By Laura Cowen
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