By Shahd Husein/GluShahd
Imagine three doctors locked in a dark room with an elephant. One, grasping the trunk, decides it’s a fire hose. The second, holding a leg, is sure it’s a tree. The third, feeling the contours of an ear, imagines it is an uncooked pie crust. Then someone flicks the light switch, and all is revealed.
That, more or less, has been the story of type 1 diabetes and the community’s definition of hypoglycemia.
Medically speaking, hypoglycemia is a complication of diabetes marked by low blood glucose levels and symptoms such as fatigue, pale skin, or shakiness. Yet, if you were to tweet out to the community asking 100 people with diabetes to define what hypoglycemia means to them, likely you’d get 100 different answers. Even the clinicians treating them might be just as varied in their responses.
Hypo-RESOLVE (Hypoglycaemia – Redefining SOLutions for better liVEs) is a 4-year, €26.8 million ($31.3 million USD) European-led research effort aimed at defining hypoglycemia. The goal is to standardize clinical trials and increase awareness of hypoglycemia, offering evidence to differentiate between what is unpleasant versus what is truly harmful.
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The project was born out of interest from Novo Nordisk in 2016. A universal definition for the condition does not currently exist, making it difficult for researchers to create comparisons between different clinical trials. This, and pressure to propose better ways to manage hypoglycemia, encouraged the Innovative Medicines Initiative (IMI) to send out a request for proposals.
Project coordinator Bastiaan de Galan, MD of Radboud University Medical Center in Nijmegen, Netherlands, and other researchers across Europe jumped at the chance. They formed a team, drafted a proposal, and became one of three proposals and groups to make it to the next stage.
That is when top industry leaders, including Novo Nordisk, Sanofi, and Abbott, joined.
The team, led by Stephen Gough, PhD of Novo Nordisk A/S, determined that there were gaps in expertise and reached out to other partners, including T1D Exchange.
“The Biobank was created to support impactful projects such as Hypo-RESOLVE,” says Biobank Director Wendy Wolf, PhD.
Indeed, T1D Exchange’s Biobank is a centralized resource containing 2,200 biological samples and associated data gathered from 8 clinical trials focused on type 1 diabetes. T1D Exchange agreed to provide data from several studies focused on severe hypoglycemia.
“T1D Exchange has agreed to provide several CGM hypoglycemia study datasets, and provide biological samples and associated data from the Severe Hypoglycemia study as part of the pre-clinical part of the overall project,” says Wolf.
The group wants to use those samples and data to find a biomarker for severe hypoglycemia, says de Galan.
“There are some individuals who have hypoglycemic events all the time. There must be something inherent.”
The trial also will focus on extracting data from 100 to 150 clinical trials that involved 80,000 to 100,000 individuals worldwide. Analysis of those findings will not only generate a clearer definition of hypoglycemia but also data about the epidemiological effects; whether or not these events can lead to an increased risk of cardiovascular disease and dementia; and the economic consequences to the healthcare system and workplace.
One important factor in this research effort is the inclusion of the input of people with type 1 diabetes. A Patient Advisory Committee will describe the psychological impacts of hypoglycemia and contribute to the design of the trial itself. One of the studies, for example, will analyze whether glucose sensors detect more hypoglycemic events than individuals themselves.
The team is now writing more research protocols and compiling data to load into a newly created database, which will eventually be available to researchers open-source.
“At the end of four years, we will have a better understanding on the clinical relevance of hypoglycemia and the long-term consequences of these events,” says de Galan. More importantly, “we will have a pretty good idea about the impact of hypoglycemia medically, psychologically, and personally on people living with diabetes.”
For more information, visit https://www.hypo-resolve.eu.