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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 Alexandria Ratzki-Leewing and Dr. Stewart Harris, 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 hypoglycemic 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 hypoglycemic 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 hypoglycemic 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 hypoglycemic 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.”