New Hypoglycemia Tech Could Have Big Benefits for Diabetes Care
The latest updates on hypoglycemia research, including the internationally acclaimed Hypo-RESOLVE project, were presented at the 2023 EASD conference in Hamburg, Germany.
Hypo-RESOLVE is an international collaboration started in 2018 that aims to advance the understanding and reduce the burden of hypoglycemia (low blood sugar) for people with diabetes.
Now included as a primary measure in pivotal studies on new diabetes therapies, hypoglycemia research has come a long way. A century ago, hypoglycemia was of little interest to the medical community, despite patient concerns around it, said Dr. Brian Frier, an honorary diabetes professor at the Queen's Medical Research Institute at the University of Edinburgh.
“Many clinicians regarded hypoglycemia as an irritating inconvenience that interfered with clinical management of diabetes,” Frier said. “A ‘Cinderella’ of diabetes research, hypoglycemia aroused modest academic interest outside a small, dedicated group of researchers.”
Of course, things have changed significantly since then, with hypoglycemia being a foremost concern for people living with diabetes and the clinicians treating them. Defined as blood glucose below 70 mg/dL, unaddressed hypoglycemia can lead to severe consequences, including coma, seizures, and even death. Mild to moderate low blood sugar also causes symptoms that can significantly impact the physical and mental well-being of people with diabetes.
Despite what diabetes experts and researchers now know, EASD panelists acknowledged there’s still much about hypoglycemia that’s not fully known – like the impacts of hypoglycemia unawareness, for example – which is why projects like Hypo-RESOLVE are so important.
A new and exciting part project is the Hypo-METRICS app, a research tool used to assess the effects of hypoglycemia on the daily functioning of people with type 1 diabetes and type 2 diabetes on insulin.
“We devised a bespoke app that reports every episode of hypoglycemia patients experienced,” said Dr. Pratik Choudhary, professor of diabetes at the University of Leicester in England. “We wanted to look at sensor-detected hypoglycemia and provide data to back up the definition of what's clinically important, and then understand the clinical, psychological, and health impacts of hypoglycemia.”
Using the Hypo-METRICS app, study participants could record in real time their glucose levels, symptoms of low blood sugar, and different domains hypoglycemia could impact, such as mood, fear of lows, sleep quality, cognitive functioning, and more. Each person was also given a Fitbit to determine whether low blood sugar episodes were happening while they were awake or asleep. The app then assessed the effects of both symptomatic and asymptomatic episodes of hypoglycemia on a person’s daily functioning.
Over the course of 10 weeks, researchers collected close to one million hours of continuous glucose monitor (CGM) data, equating to roughly 100 years of patient data. The time in range of type 1 and type 2 diabetes participants was fairly close (61% and 65%, respectively). Interestingly, Choudhary said around 65% of sensor-detected hypoglycemic events were asymptomatic.
Using CGM, it turns out that most hypoglycemic episodes were not detected by participants. Also, almost half the episodes participants reported as hypoglycemia actually weren’t, with the most common symptom thought to be related to low blood sugar being hunger. This data offers convincing evidence of the need for CGM, especially for people using insulin – regardless of whether they think they are aware of hypoglycemia episodes or not.
Researchers like Choudhary hope the new data will not only offer a better understanding of the differences and impacts of asymptomatic and symptomatic hypoglycemia, but also help push forward the overall mission of the Hypo-RESOLVE project: reducing the burden and consequences of low blood sugar episodes for people with diabetes.
Another small 2023 study concluded that together with CGM, the Hypo-METRICS app, while created for research purposes, could have clinical value for monitoring and assessing awareness of low blood sugar symptoms and the impact these episodes have on a person’s day-to-day life.
Frier said it’s still too early to judge the overall success of Hypo-RESOLVE in advancing the overall scientific knowledge of changes in blood glucose, but that it’s “reasonable to expect that some of the research outcomes will be translated into clinical benefits for diabetes care.”
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