Patient-Centric eClinical Platform Powers Virtual Data Capture in European Hypoglycaemia Study
Hypoglycaemia, when blood sugar levels are lower than normal, affects many people with diabetes and has serious complications for the disease. Hypoglycaemia, also knows as a hypo, has a significant impact on people's daily lives. However, despite the frequency of hypos and the huge number of people affected relatively little is known about these events and particularly the impacts hypos have on patients.
The European Hypo-RESOLVE study, funded by the Innovative Medicines Initiative (IMI) and involving 23 academic and industry partners, seeks to take the understanding of hypoglycaemia to the next level. A key part of the project is the Hypo-METRICS clinical study. This decentralised study aims to improve understanding of the impact of different levels and durations of hypoglycaemia on people living with diabetes.
The study will recruit 600 patients with type 1 and type 2 diabetes from eight sites across five countries: Austria, Denmark, France, Netherlands, and the UK. The dataset will be a combination of continuous glucose monitoring and activity tracking with real-time symptom reporting and patient reported outcomes (PROs). This holistic view of patients' data will allow a unique and comprehensive assessment of the prevalence, and severity, of both symptomatic and asymptomatic hypoglycaemia as well as the way it impacts people living with diabetes.
To do this, the research team is collaborating with uMotif and deploying uMotif's patient-centric eClinical platform. Patients enrolled on the Hypo-METRICS study will use the uMotif mobile app (downloaded on their own smart device) three times a day over ten weeks to provide detailed information of key parameters that can be affected by hypoglycaemia. The data collected via the intuitive and highly engaging interface of the app enables the impact of hypoglycaemia episodes to be tracked.
The patient-reported data captured through the uMotif platform will be used alongside Continuous Blood Glucose Monitoring (CGM) devices from the medical device and healthcare company - Abbott. Combining large-scale, multi-country, subjective, and objective data will drive new insights and understandings and will be the first dataset of its kind.
“We are delighted to work with uMotif on this study, which will shine a light on a poorly understood area of diabetes," said Dr Pratik Choudhary, Project Lead and Senior Lecturer and Consultant in Diabetes at King's College London. "Their platform provides us with a highly engaging app and a unique approach to capturing high volumes of quality data for our study. We needed an easy-to-use solution that can be used across multiple countries to manage a high volume of data capture. uMotif's platform also gives us the opportunity to keep our patients engaged."
For more information on the Hypo-RESOLVE check out the project's dedicated website.