"Using blood glucose numbers or improved glycemic control as outcome measures is too limited," continued Fisher. "Patient quality of life can be a better predictor of mortality and morbidity than some biologic measures."
It is critical that a comprehensive HRQOL assessment is incorporated into the structure of trials—to measure at baseline and at intervals that correspond and complement the study's treatment protocol. "Patients provide a perspective that investigators can often miss. Early and continuous patient feedback is crucial for us to develop and employ the most effective strategies that can improve QOL and biologic outcome measures."
All outcomes will not be achieved at the same pace, noted Fisher. For example, changes in glycemic control, behavior and quality of life are unlikely to occur simultaneously. "The introduction of a continuous glucose monitor might lead in the short term to improvements in glycemic control. However, the initial data overload can be very distressing for patients, so changes in quality of life might not become apparent until far later in comparison to changes in blood glucose levels."
"We must consider patient experience feedback and quality of life data to be as important as biologic outcomes," Fisher concluded.
Questionnaires Measure Quality of Life for People with Type 1 Diabetes and Their Caregivers
"Questionnaires for people with type 1 diabetes and their caregivers should soon provide a better means of measuring quality of life across the course of their lives, from early childhood through late adulthood," said Marisa E. Hilliard, PhD, Assistant Professor of Pediatrics, Baylor College of Medicine, Texas Children's Hospital, in her presentation, "Developing a Measure of Diabetes Health-related Quality of Life Across the Lifespan—Preliminary Qualitative Findings."
Hilliard and her team are currently conducting a mixed-methods study—interviewing people with type 1 diabetes and their caregivers (parents and partners) in order to better understand the quality of life issues they experience at different points in life. The interviews have informed the research team's development of new patient-reported outcome measures of diabetes-related quality of life, which will be validated across the United States this year. The new measures will be able to inform and improve patient-centered research and care.
"People with diabetes are more than their glycemic control data," she said. "The day-to-day experiences of living with and managing type 1 diabetes need to be better understood and addressed in clinical research and practice. Developed from the personal stories of people with diabetes and their family members, we hope the new patient-reported outcome measures we are developing will advance our ability to prioritize quality of life in clinical research and care. It is equally as important as glycemic control to the overall health and well-being of people with diabetes and their families."
"Several themes have emerged from an analysis of the interviews conducted to-date," said Hilliard, such as "worries about life with diabetes, challenges of managing diabetes care expenses, and the importance of supportive communication among family members and health care providers. We have learned quite a bit from how people told their stories and what they emphasized. For example, we were pleased to hear so many of our participants talking about the 'silver linings' of life with diabetes, their strategies to manage the burdens of diabetes, and their gratitude for the pace of technology advances and for the strong support of the diabetes community."
"By creating a suite of QOL measures that extend across the lifespan and can be used with both people with diabetes and their caregivers, we anticipate the measures will allow for consistent, longitudinal and outcomes research that can more accurately evaluate the impact of treatments and therapies on everyday life," she said. "This will help bring to market new intervention approaches that meet more of the needs of people with and impacted by diabetes."
Look AHEAD: Modest Weight Loss Yields Long-Term Quality of Life Benefits
Modest weight loss can significantly improve quality of life for middle-aged and older adults with type 2 diabetes, yielding benefits such as greater ease in performing daily tasks, reduced pain, greater mobility and a better state of mind, according to a review of findings from the Look AHEAD study. The analysis, "Quality of Life Findings from the Look AHEAD Study," will be presented by Gareth R. Dutton, PhD, Associate Professor of Medicine, University of Alabama Division of Preventive Medicine.
The National Institute of Health-funded Look AHEAD (Action for Health in Diabetes) trial was designed to test whether intensive lifestyle intervention (ILI)—healthy eating and increased physical activity—for weight loss could reduce the occurrence of cardiovascular disease, stroke and cardiovascular-related deaths in obese and overweight patients with type 2 diabetes. While the intervention yielded no reduction in the rate of cardiovascular events, it did achieve other benefits including improved quality of life. The trial included 5,145 adults from 16 clinical centers across the country, ages 45 to 75, with type 2 diabetes and a body mass index (BMI) greater than 25. Patient accrual was terminated after 11 years, when conclusions indicated the study's primary outcome of reducing cardiovascular events would not be achieved. At that time, median follow-up for patients was 9.6 years.
Study participants were randomly assigned to ILI (n=2,570) or standard of care diabetes support and education (the control group, n=2,575). The ILI group achieved significantly greater weight loss than the control group, with a mean weight loss of 6 percent at the end of the study, compared to 3.5 percent in the control group. Patients in the ILI group experienced significant QOL improvements, such as improved physical function and mobility (defined as the ability to get around and perform daily functions without pain or other limitations).
In addition, the ILI group experienced a 48 percent lower risk of loss of mobility, with 12.3 percent (308 of 2,514 patients) of those in the ILI group experiencing severe mobility-related disability after one year, compared to 18.9 percent (474 of 2,502 patients) in the control group. After four years, 20.6 percent (n=517) of the ILI group experienced severe mobility-related disability, compared to 26.2 percent (n=656) of those in the control group. Participants in the ILI group were also 15 percent less likely to experience elevated symptoms of depression eight years following the initiation of treatment.
Both groups experienced decreased physical function over time. The ILI group, however, demonstrated an initial significant improvement in functioning during the first year of treatment and continued to report better physical function during the following 8 years of the trial. This suggests that modest weight loss may help to mitigate deteriorations in physical function and QOL that typically occur with aging.
"It is notable that some of the quality of life benefits—physical functioning and depressive symptoms—were still present nearly a decade after individuals began treatment for weight loss," said Dutton. "These long-term benefits were also preserved even when there was some degree of weight regain."
"The results highlight the need to consider a variety of benefits for patients with type 2 diabetes who are able to lose a modest amount of weight," said Dutton. "Many of the outcomes we measured, including physical functioning, mobility and depressive symptoms, are very important to patients who are understandably interested in maximizing their quality of life and maintaining their independence for as long as possible."
Dutton's review includes data previously published in Diabetes Care, the New England Journal of Medicine, and the Archives of Internal Medicine.
The American Diabetes Association's 76th Scientific Sessions, to be held June 10-14, 2016, at the Ernest N. Morial Convention Center in New Orleans, is the world's largest scientific meeting focused on diabetes. The 2016 Scientific Sessions is expected to attract more than 16,000 attendees and offers researchers and health care professionals from around the world the opportunity to share ideas and learn about the significant advances in diabetes research, treatment and care. During the five-day meeting, attendees receive exclusive access to more than 2,500 original research presentations, participate in provocative and engaging exchanges with leading diabetes experts, and can earn Continuing Medical Education (CME) or Continuing Education (CE) credits for educational sessions. The program is grouped into eight theme areas: Acute and Chronic Complications; Behavioral Medicine, Clinical Nutrition, Education and Exercise; Clinical Diabetes/Therapeutics; Epidemiology/Genetics; Immunology/Transplantation; Insulin Action/Molecular Metabolism; Integrated Physiology/Obesity; and Islet Biology/Insulin Secretion. Margaret A. Powers, PhD, RD, CDE, President, Health Care & Education, will deliver her address on Saturday, June 11, and Desmond Schatz, MD, President, Medicine & Science, will present his address on Sunday, June 12. The top eight abstracts of this year's Scientific Sessions will be presented on Tuesday, June 14, in the Presidents Oral Session. In total, the 2016 Scientific Sessions includes 378 abstracts in 50 oral sessions, 2,021 poster presentations including 59 moderated poster discussions, and 335 published-only abstracts. The Association's 2016 Scientific Achievement Awards and Lectures are:
- Barbara B. Kahn, MD, Banting Medal for Scientific Achievement, the Association's highest honor. Kahn will deliver the Banting Medal Lecture, "Adipose Tissue, Inter-organ Communication, and the Path to T2D," on Sunday, June 12.
- Tamas L. Horvath, DVM, PhD, Outstanding Scientific Achievement Award (OSAA), will present his OSAA Lecture, "Hunger-promoting Hypothalamic Neurons Control System Metabolism and Drive Complex Behaviors and Longevity," on Monday, June 13.
- Sheri R. Colberg-Ochs, PhD, FACSM, Outstanding Diabetes Educator, will present her Lecture, "From Froot Loops® to Fitness—My Journey as an Educator and PWD," on Saturday, June 11.
- Edward W. Gregg, PhD, Kelly West Award for Outstanding Achievement in Epidemiology, will deliver his Lecture, "The Changing Tides of the Diabetes Epidemic—Smooth Sailing or Troubled Waters Ahead?," on Sunday, June 12.
Additional scientific research will be presented during 110 Symposia and nine Professional Interest Group sessions. The 76th Scientific Sessions also includes presence from more than 130 corporate and organizational exhibitors in nearly 100,000 square feet of exhibit space. Join the Scientific Sessions conversation on Twitter, #2016ADA.
About the American Diabetes Association
The American Diabetes Association is leading the fight to Stop Diabetes® and its deadly consequences and fighting for those affected by diabetes. The Association funds research to prevent, cure and manage diabetes; delivers services to hundreds of communities; provides objective and credible information; and gives voice to those denied their rights because of diabetes. Founded in 1940, the Association's mission is to prevent and cure diabetes, and to improve the lives of all people affected by diabetes. For more information, please call the American Diabetes Association at 1-800-DIABETES (1-800-342-2383) or visit diabetes.org. Information from both of these sources is available in English and Spanish. Find us on Facebook (American Diabetes Association), Twitter (@AmDiabetesAssn) and Instagram (@AmDiabetesAssn).
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SOURCE American Diabetes Association