NewsMakers
Health disparities among patients with diabetes can be improved by new approaches, insights
Patient- and clinician-focused mobile technology improves outcomes; patient support programs utilizing community health workers had positive impact on care; and new insights indicate racial/ethnic differences that impact the development of type 1 diabetes.
Health disparities in the U.S., including inequalities in the delivery of care and access to care across various racial, ethnic and socioeconomic groups, are of widespread concern, particularly in people with diabetes who require continuous, regular health care to effectively manage their disease.
Such disparities can greatly impact patients’ overall well-being and may lead to serious complications. Three studies that assessed ways to potentially decrease health disparities among people with diabetes were presented today at the American Diabetes Association’s 77th Scientific Sessions at the San Diego Convention Center.
Mobile health technology and Community Health Workers (CHWs) are two emerging strategies increasingly being used throughout the U.S. by health care teams. In the study, “Community Health Workers, Mobile Health, or Both for Management of Medicaid Patients with Diabetes” (365-OR), these approaches were evaluated to determine potential methods to improve diabetes management outcomes among minority patients. CHWs and the use of a mobile health technology app (mHealth) were tested both separately and together among 166 Medicaid patients with type 2 diabetes who receive care in Internal Medicine practices or diabetes clinics at three medical centers in Washington, D.C. At baseline, the patients had an average HbA1c level of 10.5 percent, and they were not meeting three or more of 13 wellness goals established by the study.
Patients in the 12-month study were randomly assigned to three different groups. Group 1 consisted of 56 patients who used an app—the Voxiva Care4Life (C4L) mHealth system. The C4L app helped patients manage their health with features that kept track of frequent measurements of blood sugar and blood pressure levels; provided alerts to remind them to take medications and keep doctor appointments; and offered tips on nutrition and exercise. Group 2 included 56 patients who were assigned CHWs. The CHWs were either educators or lay people who were integrated with the medical teams at each center and helped patients by providing services such as connecting them with primary care doctors and visits to see them; making home visits to help coordinate care and access to food resources and medications; providing language interpretation; helping to identify and address barriers to care; and advocating to ensure the patients received appropriate and culturally tailored health care services. Group 3 had 54 patients who were assigned both a CHW and the use of the C4L mHealth system/app.
Study endpoints included wellness/clinical goals, HbA1c levels, self-care behavior and diabetes distress. Prior to completion of the study, just 6 percent (n=11) of patients withdrew from the program.
Results indicated that within the 12 months, patients in all three groups had achieved on average 1.3 additional wellness/clinical goals from when they enrolled in the study. Additionally, HbA1c levels improved across all of the groups, and data showed that patients decreased their HbA1c levels by an average of 1.3 percent (p<0.0001). Overall, 30 percent of the patients achieved HbA1c levels of less than 8 percent—17 percent of Group 1 patients met that goal; 29 percent of the Group 2 patients; and 43 percent of the Group 3 patients; (p=0.02 vs. C4L alone). Significant improvements were also observed in all three groups of patients for numbers of hospitalizations (p=0.02); and numbers of urgent care visits (p=0.03). Diabetes distress also decreased in all groups (p<0.0001; NS between groups).
“Diabetes self-care is complex and can be a burden for many patients,” said study author Michelle Magee, MD, associate professor of medicine at Georgetown University, and the Director of the MedStar Diabetes Institute. “When we provided the support of a CHW or a mobile health application, patients with type 2 diabetes experiencing challenges with their self-care were able to achieve important improvement in health measures and a reduction in distress secondary to living with this chronic condition. Evidence to show both the potential impact of CHWs and the potential use of mobile health applications to improve health outcomes, as detailed in this study, are needed in order for health care systems to comfortably invest dollars to these new patient support approaches. Our study shows that these two strategies can significantly improve patient health. In fact, the reduction in A1C levels in our study was as positive a change as what we typically see with the addition of another antihyperglycemic medication to patients’ treatment regimens. Additionally, the resulting increase in meeting wellness goals is important for patients’ daily health and for preventing long-term diabetes complications. And, reducing hospital admissions and acute care visits are important outcomes from both the patient and health economics perspectives.”
While the approach of combining a community health worker and mobile health technology was successful in this population of Medicaid patients, the strategies developed were designed to be adaptable for use by health care teams and the patients they care for at multiple locations. The study team recommends additional research into which programs are most successful and how best to expand them for broad implementation.
Teaching clinicians how best to assist patients with diabetes and their caregivers is an important aspect of continuing medical education. While many research studies and courses explain how clinical factors influence glycemic control, translating that knowledge into a patient care setting is often challenging. This study, “A Social Media Learning Collaborative Approach to Competency-Based Training in Diabetes” (368-OR), emphasized personalizing therapeutic options to fit the individual needs of patients by developing an online, case-based, interactive training toolkit. The study aimed to facilitate the interpretation of research results and to determine how patient-centered factors such as age, gender, socio-economic status, education, race and ethnicity, body weight and current glycemic control can impact the effectiveness of various diabetes treatments.
The study investigators pooled data from 19 clinical trials with a total of 6,954 patients on 38 diabetes regimens from 1,002 clinics, in addition to using Electronic Health Records from 233,627 diabetes patients, to estimate the odds that a particular patient would achieve good glycemic control with different treatment regimens, based upon individual personal characteristics.
Subsequently, eight of the 19 randomized clinical trials contained full quality-of-life and patient satisfaction data from 2,927 patients from 413 clinics. Researchers modeled the probability of achieving HbA1c levels of less than 8 percent and less than 7 percent using 12 regimens of insulin and oral agents alone or in combination during a 24 to 52 week period. Of the 2,927 patients analyzed, 22.6 percent had type 1 diabetes and an average HbA1c level of 8.0; and 77.4 percent of the patients had type 2 diabetes and an average HbA1C level of 9.2 percent.
The primary endpoint at 52 weeks (one year) was HbA1c levels of 7.7 percent. Patients’ socio-demographic information was assessed, and treatment satisfaction questionnaires and quality of life assessments were completed throughout the study. Outcomes of HbA1c levels of less than 8 percent and less than 7 percent were modeled with logistic regression, and resulting estimators were used to develop benchmarking calculators using WebOS, Android, iOS and Windows compatible WordPress software. Calculators were then tested and optimized within case-based learning exercises. During the exercises, the clinician could simultaneously modify patient characteristics to explore and visualize how individual patient profiles might influence the probability of reaching target glycemic goals.
The study determined that the interactive learning collaboratives tested could be beneficial in translating diabetes research findings into clinical practice, while providing a novel approach to competency-based training that meets both the American Diabetes Association’s and the American Association of Clinical Endocrinologists’ clinical care guidelines.
“Relying on the published literature and more passive online courses to translate research findings into concepts that can be applied in practice is not sufficient, and often does not result in knowledge retention or a change in behavior,” said study author Donald C. Simonson, MD, MPH, ScD of the Division of Endocrinology, Diabetes and Hypertension at Brigham and Women’s Hospital and Harvard Medical School in Boston. “Additionally, data on the effectiveness of various diabetes treatments are typically based upon the average effect estimated for a specific group of individuals in randomized clinical trials. However, there is large variability in treatment response that is not well quantified. Some patients respond very well to particular therapies, while others patient do not; and much of this variability can be explained by the personal characteristics of the patients. Our research emphasizes personalizing therapeutic options to fit the individual needs of patients so that clinicians can be made aware of how patients differ in their response to the same treatment based on various patient-centered demographic, socio-economic, behavioral and quality-of-life characteristics.”
The study group plans to continue refining the predictive models and intends to help communicate, disseminate and implement their findings and toolkit into practice by extending the social media learning collaborative to additional practitioners.
Type 1 diabetes (T1D) is now recognized by scientists to be heterogeneous, meaning it can be caused by varying factors and different genes. Understanding the differences in its causes among individuals of different racial/ethnic groups can help researchers and clinicians design improved prevention strategies and treatments. The study, “Ethnic Differences in Progression to Type 1 Diabetes in Relatives at Risk,” (285-OR) examined if there are racial/ethnic differences in how T1D develops by comparing the progression of islet autoimmunity and T1D among races/ethnicities in at-risk individuals.
Researchers used data from TrialNet’s Pathway to Prevention Study screening program, which offers screening for relatives of patients with T1D in the hopes of identifying the risk for type 1 diabetes up to 10 years before symptoms actually appear.
The trial evaluated data of 4,227 TrialNet Pathway to Prevention participants between 1 and 49 years old who did not have diabetes and were autoantibody [Ab] positive relatives of patients with T1D, and followed them prospectively. The trial participants consisted of the following racial/ethnic groups: 12 percent were Hispanic/Latino; 3 percent were African American of non-Hispanic origin; 1.4 percent were Asian/Pacific Islanders of non-Hispanic origin; 79.3 percent were white of non-Hispanic origin; and 4.3 percent were “other,” non-Hispanic origin.
The analysis indicates that race and ethnicity play a role in how T1D develops, and the study specifically demonstrated that the detrimental effect of obesity on T1D risk may differ by race/ethnicity. T1D develops in stages, where individuals first progress from having a single autoantibody (i.e. marker of T1D) to having multiple autoantibodies, and later develop symptoms of T1D. The participants of Hispanic/Latino origin had a 40 percent lower risk of progressing from single to multiple diabetes autoantibodies, compared to the non-Hispanic white participants (HR=0.59, 95% CI=0.40-0.88, p=0.01). Among lean children younger than 12 years of age with multiple positive autoantibodies, the Hispanic/Latino group had half the risk of developing T1D compared to the non-Hispanic white group (HR=0.50, 95% CI=0.27-0.93, p=0.028). However, in this age group, Hispanic/Latino children were more susceptible to the effect of overweight and obesity, which increased the risk of developing T1D by 34 percent among non-Hispanic whites (HR=1.34, 95% CI=1.01-1.79, p=0.046), but quadrupled the risk in the Hispanic/Latino (HR=2.03, 95% CI: 1.25-3.31, p=0.004).
“The differences in type 1 diabetes development among races/ethnicities discovered in this study are striking,” said Mustafa Tosur, MD, a fellow in the pediatric diabetes and endocrinology division of Texas Children’s Hospital at Baylor College of Medicine. “Especially of interest is the dramatic differential effect of being overweight/obese for Hispanic/Latino children younger than 12 years of age, compared to non-Hispanic white children in the same age group. The research demonstrates that racial and ethnic differences should be taken into consideration when counseling family members who are at-risk of developing type 1 diabetes, and when designing preventive care and treatment options. Considering the obesity epidemic in children, which is more prevalent among minorities, and the frequency of type 1 diabetes is growing most in Hispanics in the U.S., these findings have important public health implications.”
Tosur noted that because the study participants were autoantibody-positive relatives of patients, the results of the study are not necessarily representative of the general population. The study team plans to conduct further research on possible reasons for the differences among the various racial/ethnic groups.
NewsMakers
Common drug class may increase risk of heart disease
The risk of cardiovascular disease increased in line with how much anticholinergic medication the participants used each year. Those with the highest exposure had a 71 per cent higher risk of a cardiovascular event than people who did not use anticholinergic medication at all.
People who use drugs with anticholinergic effects, including certain antidepressants, drugs for urinary incontinence and common antihistamines, are at higher risk of developing cardiovascular disease.
This is shown in a study from Karolinska Institutet published in BMC Medicine.
Anticholinergic drugs reduce the effect of the neurotransmitter acetylcholine and are commonly prescribed to middle-aged and older people. This large group of drugs includes antihistamines used for allergic conditions, anxiety or insomnia, drugs for urinary incontinence, and certain antidepressants, where tricyclic antidepressants have a strong anticholinergic effect, whereas SSRIs have a weaker effect. A high cumulative use of these drugs, referred to as anticholinergic burden (see fact box), has previously been linked to impaired cognitive ability.
May affect heart regulation
The new study suggests that the drugs may also affect the parasympathetic nervous system and thereby the regulation of the cardiovascular system. The results show that it may be important to monitor the total drug burden in everyday clinical practice.
The study included more than 500,000 people in Stockholm, Sweden, who were 45 years of age or older and had no prior cardiovascular disease, except for hypertension, at the start of the study. The researchers followed the participants for up to 14 years and analysed how the use of anticholinergic drugs was associated with the development of cardiovascular disease.
“Many of these drugs are used by older people and by people with multiple medical conditions. We wanted to investigate whether the total exposure had any significance for the risk of developing cardiovascular disease over time,” says Nanbo Zhu, postdoctoral researcher at the Department of Neurobiology, Care Sciences and Society, Karolinska Institutet.
71 per cent higher cardiac risk
The study showed that the risk of cardiovascular disease increased in line with how much anticholinergic medication the participants used each year. Those with the highest exposure had a 71 per cent higher risk of a cardiovascular event than people who did not use anticholinergic medication at all. The association was seen for all types of cardiovascular disease but was particularly clear for heart failure and various forms of arrhythmia.
“Our results indicate that the cumulative drug burden can affect heart regulation, not only in the short term but also over the long term. This does not mean that the drugs should always be avoided, but that exposure should be monitored carefully,” says Hong Xu, assistant professor at the Department of Neurobiology, Care Sciences and Society.
The researchers point out that the study is observational, meaning it cannot establish a causal relationship. Other factors, such as underlying diseases, may also influence the associations.
The work was carried out within the Stockholm CREAtinine Measurements project in collaboration between several research groups at Karolinska Institutet and Region Stockholm. The study was funded by the Swedish Research Council, the Center for Innovative Medicine Foundation, and other foundations. Some researchers report assignments for the pharmaceutical industry, which are disclosed in the scientific publication.
NewsMakers
Mindfulness practices found to significantly reduce depression symptoms, especially for those with early-life adversity
Mindfulness interventions help by regulating our emotions better when different challenges come up. For someone who has experienced childhood neglect or abuse, mindfulness training can help us make sense of that and respond skillfully to this moment in time.
A new study reveals that mindfulness practices may significantly reduce depression symptoms, particularly in people who have experienced early-life adversity, such as childhood abuse and neglect.
Led by Eric Loucks, professor of medicine, epidemiology, and of behavioral and social sciences and director of the Mindfulness Center at Brown, the study enrolled 201 participants, 101 of whom were randomized into the Mindfulness-Based Blood Pressure Reduction Program, while 100 were randomized into an enhanced usual care control, which included home blood-pressure monitors, physician access and health-education materials. Researchers also had a measure of participants’ early-life adversity, particularly their exposure to abuse or neglect.
Loucks and his team followed participants for six months to assess changes in blood pressure, health behaviors and mental health, finding that those in the mindfulness program showed significant improvements in their depression symptoms. Additionally, participants who experienced childhood neglect showed greater improvements in depression symptoms than those who had not. A similar, though less pronounced, trend was observed among people with a history of childhood abuse.
“In this program, that was primarily designed to lower blood pressure while addressing whole-person health, we also saw that mental well-being, particularly around depression symptoms, improved in participants that went through the program,” Loucks said. “The findings suggest that cultivating mindful self-regulation skills–such such as self-awareness, attention control and emotion regulation–may help interrupt maladaptive patterns shaped by past experiences.”
Over the last 15 years, Loucks has been studying social determinants of health such as early-life adversity and its impacts on cardiovascular health, body mass index and blood pressure. “I came to a point where I wanted to not just document it, but do something about it, and I wondered if mindfulness training might help,” he said. “I’d gone through a lot of mindfulness training myself outside of work and started to get trained up in mindfulness programs that are specific to health contexts.”
Loucks began to study the Mindfulness-Based Stress Reduction program, running it through two clinical trials that were funded by the NIH and finding that it reduced blood pressure in both trials. He also wanted to look at the intervention from a whole-person perspective.
“If we look at everyday folks out in the world, those that had exposure to early life adversity, like abuse and neglect, tend to have worse mental health and also worse cardiovascular health,” Loucks said. “Mindfulness interventions help by regulating our emotions better when different challenges come up. For someone who has experienced childhood neglect or abuse, mindfulness training can help us make sense of that and respond skillfully to this moment in time.”
Loucks discussed this work during a keynote address at the U.S. DOHaD Society this year. “It felt like a coming-home moment to see that this intervention, originally developed to address psychosocial factors that influence health, had even stronger effects among people with early-life adversity, particularly on depression,” he said. “It’s been about a 15-year arc of research that culminated in these findings.”
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High-fiber diet linked to reduced risk of heart disease in night shift workers
A moderate intake of about 19 grams of fibre per day was linked to a lower risk for those who worked night shifts regularly. For those who worked night shifts sporadically, about 15 grams was enough. The current recommendation for adults is about 25 grams of dietary fibre per day.
People who work at night have a higher risk of coronary artery disease, a type of heart disease. A new study suggests that a higher fibre intake in the diet may help reduce this risk. The study included over 220,000 adults in the UK and is published in the European Journal of Epidemiology.
The human body is built to sleep at night. This means that working during the night goes against this natural pattern, and can place additional strain on the body, including the heart. Previous research has linked night work to an increased risk of coronary artery disease. Since night work is often unavoidable, the researchers wanted to investigate whether certain dietary habits might have a protective effect.
More fibre associated with lower risk
The researchers used data from 220,000 adults in the UK Biobank (2006–2010) and divided the participants into three groups:
- Day workers
- Shift workers who worked night shifts sporadically
- Regular night shift workers
The participants had completed a detailed questionnaire about their dietary habits. During a follow-up after about 12 years, it was found that night shift workers who consumed little fibre in their diet had a higher risk of coronary artery disease than those who consumed more fibre.
“A moderate intake of about 19 grams of fibre per day was linked to a lower risk for those who worked night shifts regularly. For those who worked night shifts sporadically, about 15 grams was enough. The current recommendation for adults is about 25 grams of dietary fibre per day,” says Diana Nôga, lead author and researcher at Uppsala University.
The researchers stress that the figures from the study are not official dietary recommendations. But they do show a pattern in this UK study: a higher dietary fibre intake was linked to a lower risk of heart disease among night shift workers.
“The link between fibre and a lower risk of heart disease is not just because those who eat more fibre generally have a healthier lifestyle. We know this because we adjusted for various lifestyle factors in the analysis. One possible explanation, supported by previous research, is that fibre in the diet can improve intestinal flora and also reduce lipids, which can be particularly good for the heart in people who work at night,” says Christian Benedict, senior author of the study and Professor of Pharmacology at Uppsala University.
Dietary fibre can support heart health
According to the researchers, an increased intake of fibre-rich foods such as whole grains, vegetables, fruit, legumes and lentils may be a simple way to improve heart health for night shift workers. However, this requires that you do not have any medical obstacles to doing this, such as chronic gastrointestinal diseases.
“Dietary changes should be seen as a complement to, not a substitute for, other heart health-promoting habits such as not smoking, remaining physically active, and getting enough sleep,” says Diana Nôga.
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