Combination of wearable data and digital questionnaires: FeMFit study by Data4Life opens up new paths in research on female health
Potsdam (Germany), 05.04.2022. The Potsdam-based company Data4Life is expanding its research activities around the collection of real-world data. In January 2022, the non-profit organization launched the digital female health study FeMFit (Feasibility study on Menstrual cycles with a Fitbit device). As part of the study, Data4Life is collaborating with gynecologist and digital health expert Priv.-Doz. Dr. med. Maike Henningsen, who holds a junior professorship for Digital Health at the University of Witten-Herdecke and runs a gynecology practice in Berlin.
Data-driven female health research through wearables
Wearable devices enable continuous and easy data collection of real-world data. According to the German Federal Statistical Office, 15.5 million people in Germany were using wearable devices such as fitness trackers or smartwatches at the beginning of 2020, with sales increasing fifteen fold between 2014 and 2020*. As digital biomarkers, the activity data collected via wearables can indicate certain diseases at an early stage or accompany the treatment of diseases. Particularly in the area of female health, or menstrual health, relevant insights into the female body can be gained via certain digital biomarkers, thus opening up new data-driven research paths.
The FeMFit study is a first step to find out to what extent linking digital questionnaires with wearable data enables valid digital data collection on the menstrual cycle.
"For the first time, we have the chance to collect data on a daily basis and associate it with clinical parameters – this is a first in gynecology and will hopefully provide new insights into a woman's physical condition and be the basis for further medical developments," says PD Maike Henningsen.
People aged 18 to 30 with a regular menstrual cycle who are patients in the practice "Frauenmedizin am Bundesplatz" in Berlin, Germany, can participate in the digital study. Participants wear a Fitbit brand fitness tracker throughout the study period, which measures various digital biomarkers such as physical activity, sleep duration, step count, and resting pulse. In addition, the subjects regularly answer questions about their menstrual cycle via the Data4Life study account.
"To further improve the quality of healthcare, the perspective of patients should be combined with the collection of digital biomarkers" says PD Cornelius Remschmidt, MD, Chief Medical Officer at Data4Life who is leading the study. "The combination of subjective and objective real-world data opens up new possibilities for digitalized, evidence-based health research."
The FeMFit study is the first step for possible further studies to investigate cycle-dependent reactions to external influences, such as medication intake, infections, or stress, and has been approved by the Ethics Committee of the Berlin Medical Association (Eth-24/21). Based on these new insights into the female body, treatment can be re-evaluated and, where necessary, adapted to the menstrual cycle.
*Source: Pressemitteilung Nr. 078 des Statistischen Bundesamts vom 22. Februar 2021
D4L data4life gGmbH is a nonprofit organization funded by the Hasso Plattner Foundation. With a team of over 100 people, Data4Life is working towards its vision of a world where health data is ready for research. Data4Life aims to enable data-driven personalized medicine and improve the prevention, diagnosis, and treatment of diseases by making medical and real-world data available in digital, interoperable form. In pursuit of these goals, Data4Life collaborates with leading public health institutions, esteemed medical experts, and renowned research institutions worldwide, including the Robert Koch Institute, Mount Sinai Hospital in New York, and Fraunhofer HHI.
Data4Life was founded in 2017 and is headquartered in Potsdam, Germany with offices in Berlin, Barcelona, and Singapore. The CEO is Christian-Cornelius Weiss. In July 2019, Data4Life was certified according to ISO 27001 based on the IT-Grundschutz by the German Federal Office for Information Security. More details on www.data4life.care.
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