Advancing
diabetes research and care

When it comes to effective diabetes patient care, health experts must look beyond the clinics and clinical trials.

It’s a revelation from research conducted by endocrinologist Dr. Kristin Clemens, which identified the socio-economic challenges confronting patients while managing their diabetes and advanced kidney disease.

“Many patients in our study came from lower-income backgrounds, so it can be difficult for them to pay transportation and parking costs for medical appointments,” says Clemens, a clinician-researcher at St. Joseph’s Health Care in London, Ont. “It can also be challenging to take time out of their workday to see specialists for their various health conditions.”

Researchers have made significant strides in improving quality of life for people with diabetes. New medications and technologies—like insulin pens that connect directly to smartphones—have made self-guided disease management easier for these patients. But research has historically focused on treatments for patients in the earlier stages of diabetes, and fewer studies address best practices for those with later-stage diabetes living with multiple health complications. These comorbidities typically exclude patients from clinical trials and research studies, limiting foundational research for this patient population.

Aiming to change that dynamic, Clemens has focused her research on diabetes patients with comorbidities, or additional medical conditions, including advanced kidney diseases.

Clemens recently examined diabetes care in a population-based study of more than 4,000 Ontarians withdiabetes undergoing dialysis treatment for kidney disease. Over a two-year period, the study found 40 per cent of patients experienced a gap in their diabetes care, a disconnect between best practices and their actual quality of care.

Her team then conducted a qualitative, patient-oriented study to uncover the factors contributing to those gaps. This work revealed several unique challenges patients faced while managing diabetes and advanced kidney disease. The cost of transportation and parking, and taking time away from work are factors that are preventing patients from accessing diabetes care. Many patients also voiced a desire for professional help in coordinating their diabetes care.

Building on these insights, Clemens’ team implemented a diabetes outreach program in the dialysis unit at London Health Sciences Kidney Care Centre, with financial support from the St. Joseph’s Health Care Foundation. Led by a diabetes educator, the program offers health management assistance to patients with diabetes while they receive dialysis treatment. The educator helps patients stay on schedule with insulin shots and other medications. They also remind patients to have screenings conducted in optometry and podiatrist units to help prevent impaired vision and foot ulcers that may result from increased blood sugar.

To ensure consistent care, the educator communicates regularly with the patient’s nephrologists, family doctors and endocrinologists. Clemens says the program has improved the patients’ self-management skills, blood sugar levels and overall satisfaction with their level of care.

Clemens hopes her team’s research will support similar programs for patients living with diabetes and comorbidities.

“Before we pour our dollars into clinical trials, it’s essential to understand what matters to patients,” she affirms. “Through this work, I’ve developed an even deeper understanding of what my patients experience on a daily basis, and that has transformed how I practice as a physician. I hope this research helps emphasize the importance of patient-centered efforts to improve the health and quality of life of all patients with diabetes.”

Results of a break-through study are giving voice to people living with diabetes and hypoglycemia, and challenging traditional assumptions surrounding the disease.

Led by Western University’s Stewart Harris and Alexandria Ratzki-Leewing, the year long iNPHORM study is the first of its kind to be conducted in the U.S. and follows an earlier Canadian study that reveals unexpectedly high rates of self-reported hypoglycemia episodes among patients with diabetes.

“Insulin treatment is a double-edged sword,” says Ratzki-Leewing, a PhD candidate at Western’s Schulich School of Medicine & Dentistry. “It’s essential to saving the lives of people with diabetes, but we rarely talk about how insulin regulation can lead to hypoglycemia episodes, which can then have a life-threatening impact on patients’ physical and psychosocial health.”

Most studies have used hospital records to estimate rates of hypoglycemia episodes among people with diabetes, but these studies can only account for the minority of episodes that end in hospitalization. Through the iNPHORM study, Harris and Ratzki-Leewing set out to identify and explain the true burden of hypoglycemia.

To meet these objectives, the team gathered monthly patient-reported data from 1,206 Americans living with diabetes from February 2020 to March 202. Participants recorded changes to their medications, health-care providers, insulin dosages and other effects of managing their diabetes.

“It was challenging to develop comprehensive questions that addressed our goals while ensuring participants would remain committed throughout the study,” says Dr. Bridget Ryan, assistant professor at Schulich Medicine & Dentistry who served as the team’s expert in survey methods. “As the study unfolded, we were grateful that so many people consistently engaged for the full 12 months. It seemed patients cared about this work just as much as we did.”

Among other observations, the team discovered that 95 per cent of self-reported hypoglycemia episodes didn’t result in hospitalization. “If you rely solely on hospitalization records to provide descriptive evidence for hypoglycemia rates, you only capture five per cent of all total episodes, which is far from representative of a real-world diabetic population,” Ratzki-Leewing explains.

These discrepancies led the team to begin developing a risk-prediction model that gives physicians a practical tool for diagnosing and treating hypoglycemia in routine clinical settings. The model will account for socio-demographic, psychosocial, situational/environmental and behavioural risk factors in people with diabetes, a novel approach compared to more traditional clinical indicators, such as patient medications or the length of time a patient has lived with diabetes.

“Often in the clinic, simply asking whether a patient has experienced an episode doesn’t give the patient space to express the reality of their day-to-day experiences,” Harris notes. “Through this project, we ultimately want to build a sturdier foundation for conversations between patients and clinicians.”

Ratzki-Leewing cites the project’s storytelling nature as one of the most meaningful aspects of her work.

“Many of these people have never had the chance to share their experiences with anyone in the clinical or scientific world,” she says. “Hypoglycemia is not just about the episode itself. These individuals live with life-threatening risk every single day. I’m incredibly honored to be trusted with their stories and work toward providing more informed and supportive care for them and their families.”

Life-changing innovations require a level of risk. When a researcher redesigns her methodology to become the subject of her own study, it’s unique, brave territory.

And that’s exactly what Michelle Mottola did.

In 1996, Mottola, then pregnant with her first child, became the first human subject of the R. Samuel McLaughlin Foundation – Exercise and Pregnancy Research and Innovation Lab at Western University. As a kinesiology professor and the lab’s founding director, Mottola tested an activity and nutrition-based framework designed to improve the health of pregnant women through exercise and nutrition.

After working closely with more than 500 expectant mothers, Mottola is now considered one of North America’s top researchers in the study of exercise during pregnancy.

“My job is preventing diabetes between conception and birth but my passion is helping new mothers,” says Mottola, who also participated in the studies during her own second pregnancy.

With nearly 30 years of experience, Mottola stands at the forefront of gestational diabetes research. She co-led the team whose work culminated in the 2019 Canadian Guideline for Physical Activity Throughout Pregnancy, a set of recommendations for physical activity for pregnant women developed with the Canadian Society for Exercise Physiology (CSEP).

In addition to providing a nationally recognized framework for gestational diabetes prevention, CSEP guidelines are cited in the World Health Organization’s 2020 Guidelines on Physical Activity and Sedentary Behaviour.

The remarkable reach of Mottola’s work illustrates how research-intensive institutions, in collaboration with community members, can meaningfully improve human health and health-care delivery.

And for millions of women, her research has redefined healthy pregnancy as a positive outcome of exercise and nutrition.

The strength and leadership of Indigenous communities is key to providing effective diabetes care for their populations, according to one of Canada’s foremost experts in fighting the deadly disease.

Dr. Stewart Harris, the Diabetes Canada Chair in Diabetes Management, develops and delivers strategies to support Indigenous communities and other vulnerable and racialized populations to help manage and reduce diabetes-related outcomes.

A professor of family medicine at Western’s Schulich School of Medicine & Dentistry, Harris launched a special project more than a decade ago with the goal of finding locally-led solutions for diabetes treatment and prevention by providing improved supports and service in Indigenous communities. The program, which has grown substantially since its inception, partners quality improvement strategies developed at Western with community leaders from coast to coast to coast.

“The community members are the experts at knowing what will work within their contexts,” says Harris. “What I learned in my work is that one of the greatest strengths for those living on reserve is the community; and communities are capable of doing incredible things.”

Originally conceived as the Canadian Institutes of Health Research-funded “Forge Ahead”, the program merged with Western’s SOAR: Pathway to Wellness Program in 2019 leading to further improvements for Indigenous communities by training and coaching local health care providers and has now evolved into the national REACH program.

“There is no cookie-cutter approach that works for all communities,” says Cynthia Benoit, a Miawpukek social worker, who worked on the project. “Forge Ahead empowered the community to develop a plan to increase health outcomes for persons with diabetes, and was instrumental in making sure our plan was reflective in supporting what was best for the communities and the health centres.”

Patient advocate

Harris has spent his career ensuring that all patients with diabetes – regardless of their circumstances – have access to the best possible care.

Beginning his career as the medical director of the University of Toronto’s Sioux Lookout Program located in the remote community of Sioux Lookout, Harris has always focused on ensuring that those with barriers to care have the supports they need to manage their disease, not just in his home community of London, but right across the country.

In London, along with nurse practitioner Betty Harvey, Harris established the Primary Diabetes Support Program at St. Joseph’s Health Care London more than a decade ago. The program provides care for at-risk patients with diabetes, including those without a family doctor, those in the community experiencing homelessness, and immigrants or refugees with language or cultural barriers to care.

“We look after those patients that no one else looks after,” says Harris, who says many of these patients have other related conditions, like kidney disease and heart failure; and may have exacerbated risk factors like food insecurity, lack of access to housing and medications.

“If they don’t have a family doctor, they don’t have anyone advocating for them and helping them access care. That’s where we come in,” says Harris.

Jim Telfer has been living with diabetes since he was 12 years old – and knows all too well the complex nature of the chronic disease and the serious health complications it causes.

So, when he saw an opportunity to participate in a clinical trial, it was an easy decision.

“I really wanted to be a part of that, to be helpful for the future,” says Telfer, a London, Ont.-based design artist.

Telfer is a patient at St. Joseph’s Health Care London’s Centre for Diabetes, Endocrinology and Metabolism. It is the primary regional centre for diabetes and endocrine disease management in Southwestern Ontario, bringing together comprehensive diabetes education, leading-edge care and research, and an expert team of care providers and researchers.

The Diabetes Control and Complications Trial (DCCT) – an international landmark research that began in 1983 – had set out to explore how controlling blood glucose levels of people with Type-1 diabetes can affect their health and alter the progression of the disease and its long-term complications.

London was one of the two Canadian sites to participate in this long-term, international trial that has changed the way diabetes is managed globally.

More than 1,441 patients participated in the decade-long study. Participants were randomized into two different groups. One group received a more intensive treatment of three or more insulin injections per day or an insulin pump with blood glucose monitor. The second group received the standard treatment of one or two injections of insulin per day with self-monitoring of urine or blood glucose.

The ground-breaking results, published in 1993, showed that keeping blood glucose levels close to normal greatly decreased diabetes patients’ chances of developing eye, kidney and nerve disease. The results were published in the New England Journal of Medicine, and soon after physicians around the world began treating diabetes differently.

While the results of the trials provided significant advancements in diabetes care, the research did not end there.

As the DCCT concluded, study participants were invited to engage with a new multicentre, longitudinal observational study called Epidemiology of Diabetes Interventions and Complications (EDIC). As a follow-up study to DCCT, EDIC was designed to test the durability of the DCCT effects on the more-advanced stages of diabetes complications, including cardiovascular disease.

This study continues today and participants meet with researchers annually. They undergo various long-term health assessments, including blood work, cognitive testing, cardiac magnetic resonance imaging, and retinal imaging.

Dr. Charlotte McDonald, an endocrinologist and one of the principal investigators for the EDIC study, says that with 24 study sites across North America, including London, Ontario, and around 1,400 participants, the study will yield a large amount of data that will allow clinicians to better understand the complications of diabetes and the long-term impacts of its treatment.

“We still have participants involved in the EDIC study that started over 28 years ago, making this one of the longest follow-up studies of diabetes patients ever,” says Marsha Driscoll, Research Coordinator at Lawson Health Research Institute, the research arm of London’s hospitals. “Around 90 per cent of those patients are still actively followed which is remarkable for a study of this duration.”