Coala-Life Group AB (publ), a leading company in cloud-based remote monitoring of heart and lung diseases, announces today that the TITAN-DM study – a clinical observational study aimed at increasing knowledge about the incidence of atrial fibrillation in people with diabetes – is now fully recruited with 600 participants. The study participants are followed with Coala Heart Monitor daily for three months. TITAN-DM is expected to be completed in the spring of 2022 with results for presentation in the autumn of 2022.
"It was natural for us to design a study where the detection of atrial fibrillation during the study period is expected to contribute to direct benefit for the individual and society," says Peter Magnusson, chief physician, with Dr., Region Gävleborg and principal researcher affiliated with Uppsala University and Karolinska Institutet.
People with diabetes have an increased risk of developing atrial fibrillation, a disease that increases the risk of stroke. Atrial fibrillation causes over 10,000 cases of stroke in Sweden every year. It is the most common arrhythmia and there is an increased risk of developing dementia and premature death. In the TITAN-DM study, the Coala Heart Monitor is used to take an ECG daily and detect atrial fibrillation in the study participants during the study. If atrial fibrillation is found, blood-thinning treatment of the NOAK type can be prescribed, which effectively protects against stroke. Recruitment has taken place in collaboration with patient- and senior-citizen organizations.
The pandemic has entailed special challenges and changed conditions for conducting clinical studies. Ability to reach broad geographical and demographic distribution have been limited. In TITAN-DM, recruitment and inclusion has taken place through Bank ID and a completely digital process, enabling broad inclusion throughout Sweden.
"By working with patient associations as a basis for recruitment and a digitized inclusion procedure, we have managed to complete the study in just 12 weeks," comments Michel Tagliati, medical doctor, project manager and CEO of Proaktiv Hälsa.
"It feels important to work to give our members the opportunity to contribute to clinical research that contributes to improving care for people with diabetes," says Veronika Lindberg, head of the Greater Stockholm Diabetes Association.
“Our association and our members want to actively contribute to clinical research. For us, we also saw a direct gain for our members ", says Marie Näslund, head of social policy at the National Association of Pensioners.