First Participant Recruited in PhaseV Study on Chronic Spontaneous Urticaria

First Participant Recruited in PhaseV Study on Chronic Spontaneous Urticaria

Aug 20, 2025

Copenhagen, Denmark 

We are pleased to share a new milestone from the national cross-sector innovation programme, PhaseV, supported by Innovation Fund Denmark. The project is pioneering a digital-first approach to decentralised, real-world clinical studies across several disease areas.

The Work Package 6 (WP6) study, focusing on chronic spontaneous urticaria (CSU), has successfully recruited its first participant. This marks the beginning of an important research effort that will explore how digital tools can support patients and clinicians in monitoring symptoms and treatment over time.

ABOUT THE PROJECT

The CSU study aims to develop and validate novel digital assessment tools that use patient-submitted photographs and questionnaires to remotely track urticaria severity in daily life. In addition, the study will explore how lifestyle and environmental factors (such as activity and sleep) influence CSU symptom flares, and will test new methods for conducting decentralised clinical research, including remote informed consent.

In PhaseV, participants use connected devices and a study app developed by Monsenso to report patient-generated health data from home. Clinicians can access these data through a dedicated web portal, helping to bridge the gap between daily life and the clinic.

The Urticaria study is one of three studies within PhaseV, alongside studies in obesity and diabetic foot ulcers, all aiming to demonstrate how decentralised designs can make clinical research more efficient, patient-friendly, and closer to real-world practice.

We look forward to following the progress of the CSU study and the insights it will generate for the future of clinical research and patient care.

 

Private-PUBLIC partnership

The consortium is led by Monsenso and includes partners across academia, healthcare, industry, and innovation: Aarhus University, Research Unit for General Practice (FEAP), Bispebjerg Hospital, Steno Diabetes Center Aarhus, Aarhus Municipality, the Danish Technological Institute, the Alexandra Institute, the Copenhagen Institute for Futures Studies, Danish Life Science Cluster, Novo Nordisk, and Novartis.

PhaseV aims to deliver a scalable digital platform for effective decentralised recruitment, continuous data capture, and phase-V style real-world studies that can strengthen patient care and decision-making.

For more information about the project and its progress, visit the PhaseV website or the Danish Life Science Cluster project page, or follow Monsenso on LinkedIn.

 To learn more or explore a pilot or integration, book a demo or get in touch via our website.

Solution
The Power of Citizen-Generated Health Data – a Business Review Life Science Podcast

The Power of Citizen-Generated Health Data – a Business Review Life Science Podcast

Aug 4, 2025

Copenhagen, Denmark 

Monsenso is happy to announce that our CEO, Thomas Lethenborg, recently participated in the Business Review Life Science podcast, joining a compelling panel discussion on the transformative potential of real-world patient-reported data.

The episode, titled “Borgernes egne sundhedsdata” (“Citizen-Generated Health Data”), will be aired on August 11th and features key voices from the ongoing Phase V innovation project.

Hosted by Heidi Bendtsen Nielsen, the podcast explores how personal health data – such as information collected via smartphones, blood pressure monitors, or smartwatches – can be used to enhance treatment outcomes, support prevention, and relieve pressure on healthcare systems.

Thomas Lethenborg was joined by:

  • Frederik Knud Nielsen, Healthcare Partnership Director at Novartis
  • Frederik Mølgaard Thayssen, Principal Project Manager at the Alexandra Institute

Together, the panel addressed several timely and critical questions:

  • What opportunities do Danes have today to collect and contribute their own health data?
  • How can these data be validated and effectively integrated into healthcare practices?
  • What barriers – regulatory, ethical, or technical – still need to be overcome?
  • How can public-private collaborations, like Phase V, unlock the full potential of data-driven healthcare?

“At Monsenso, we see real-world data as a key enabler of more personalised, preventive, and efficient healthcare”, said Thomas Lethenborg. “This podcast gave us a great platform to highlight not only the technological possibilities but also the importance of patient involvement and responsible data use.”

The discussion also emphasised the need for stronger political commitment to support personalised, data-driven innovation in healthcare and showcased examples of successful collaborations between industry and the public sector – including the Phase V initiative.

Listeners can access the full episode (in Danish) on the Business Review Life Science platform.

To learn more or explore a pilot or integration, book a demo or get in touch via our website.

 

Solution
Monsenso supports UK research on treatment-resistant depression

Monsenso supports UK research on treatment-resistant depression

Jul 24, 2025

Copenhagen, Denmark

Monsenso delivers digital research platform for groundbreaking UK project on treatment-resistant depression.

Monsenso A/S is proud to announce its strategic role as the digital technology partner for the DECODE project in the United Kingdom. The initiative, led by the University of Birmingham, in collaboration with the Mental Health Mission Midlands Translational Centre, Birmingham and Solihull NHS Foundation Trust, and Nottinghamshire Healthcare NHS Foundation Trust, is focused on transforming clinical research and care for patients with treatment-resistant depression (TRD).

As part of the project, Monsenso’s digital platform will enable stratified recruitment, remote data collection, and standardised clinical endpoint measurement across multiple NHS sites — laying the groundwork for improved precision in depression research and future interventions.

Addressing a Critical Public Health Challenge

Treatment-resistant depression (TRD) affects almost half of patients diagnosed with major depressive disorder meaning they do not respond to two or more oral antidepressants, and TRD is associated with poorer outcomes, including high comorbidity, suicidality, and economic burden. 

The DECODE project aims to build a digitally enabled recruitment and monitoring infrastructure to better identify, understand, and ultimately treat this complex condition.

Recruitment is expected to begin in Q3 2025, with Monsenso’s platform playing a pivotal role in data collection and patient stratification.

Quote from Monsenso CEO

“We are honoured to support such an important national initiative addressing one of the most challenging areas in mental health. Monsenso’s platform is designed to help healthcare providers and researchers make better, data-driven decisions through real-time digital monitoring and standardised assessments,” said Thomas Lethenborg, CEO of Monsenso.

“This project reaffirms our strategic positioning as a trusted partner in supporting decentralised, real-world data studies across Europe with healthcare, academic institutions and pharmaceuticals.”

Strategic Importance for Monsenso

  • Expansion into the UK: Strengthens Monsenso’s footprint within the UK healthcare ecosystem, particularly within the NHS and leading academic partners.
  • Scalable digital, decentralised research model: Demonstrates the scalability and flexibility of Monsenso’s platform for decentralised multi-site health research.
  • Expansion possibilities: If successful, the DECODE project has potential to pave the way for geographic expansion and follow-on precision-medicine studies.
  • Validation of product-market fit: Reinforces Monsenso’s role in delivering regulated, patient-centric digital tools that meet the complex needs of decentralised, real-world studies in psychiatric conditions and beyond.

Academic and Clinical Endorsement

Professor Steven Marwaha, Co-director of the Midlands Mental Health Mission and Professor at the University of Birmingham, stated:

“This partnership with Monsenso enables us to streamline and enhance the way we recruit patients and assess outcomes. By integrating continuous data collection, digital phenotyping tools and standardising clinical endpoints, we can accelerate our understanding of treatment-resistant depression and drive more precise and personalised future interventions.

Click the button below for more information about the Monsenso solution.

Solution
Participant Recruitment Begins for MENTBEST Research Project in Denmark

Participant Recruitment Begins for MENTBEST Research Project in Denmark

Jun 19, 2025

Copenhagen, Denmark 

We are excited to announce the launch of participant recruitment for the Danish arm of the European research project MENTBEST. The project is now seeking individuals to join a new study led by the Copenhagen Affective Disorder Research Center at Psychiatric Center Copenhagen, Region Hovedstadens Psykiatri.

About the Study

The aim of the study is to explore how a digital app can support individuals in managing depressive symptoms. As part of the larger MENTBEST initiative, this research trial will contribute to the development and validation of a personalised, AI-enabled self-care programme built on Monsenso’s digital health platform.

Who Can Participate?

We are looking for individuals who are currently experiencing depressive symptoms or who have previously been diagnosed with depression.

Common symptoms include:

  • Persistent sadness
  • Reduced interest or pleasure in activities
  • Lower energy levels
  • Difficulty concentrating or making decisions
  • Fatigue and disrupted sleep
  • Changes in appetite

If this sounds familiar and you are interested in contributing to mental health research, we would like to hear from you!

About MENTBEST

MENTBEST (Mental Health Best Practices) – a Horizon Europe project funded by European Commision – is aiming to develop innovative, community-based mental health interventions. It targets vulnerable populations across Europe who are at high risk of developing mental health challenges due to rapid societal change. The project spans five countries: Denmark, Germany, Spain, Ireland, and Greece, and brings together 14 expert organisations under the leadership of the European Alliance Against Depression (EAAD).

The project focuses on delivering scalable, digital, evidence-based tools to strengthen self-help and resilience in the face of mental health challenges. In Denmark, the trial is being conducted in partnership with Monsenso, a digital mental health company, and mental health researchers from Region Hovedstaden.

Contact Information

To participate or learn more, please contact:

Malene Schwarz Dyrehot
 Project Nurse, CADIC
 📞 +45 21 52 34 53
 📧 pck-mentina.region-hovedstadens-psykiatri@regionh.dk

For updates and further information, follow the MENTBEST LinkedIn page.

 To learn more or explore a pilot or integration, book a demo or get in touch via our website.

 

Solution
Start of Patient Recruitment for the Phase V Project

Start of Patient Recruitment for the Phase V Project

May 28, 2025

Copenhagen, Denmark 

We are delighted to share an update on PhaseV, a national cross-sector innovation effort, supported by Innovation Fund Denmark, that aims at advancing decentralised, real-world clinical studies in Denmark.

ABOUT THE PROJECT

PhaseV is developing a new, digital model for running clinical studies that brings monitoring closer to patients and clinicians over longer periods. It collects patient-generated real-world data via questionnaires and connected devices, presenting insights to patients in an app and to clinicians in a web portal, both developed by Monsenso. The programme will pilot three proof-of-concept studies in obesity, diabetic foot ulcers, and chronic spontaneous urticaria.

Recruitment has begun for the obesity research arm of the PhaseV project

Steno Diabetes Center Aarhus is recruiting participants for a 24-week, fully online study. Participants receive personal guidance and support from clinical dietitians while data are gathered digitally at home using a smartwatch, connected scale, and the study app.

The primary objective of this study is to assess the feasibility of enrolling participants with overweight or obesity into weight management programs within a decentralised clinical trial (DCT) framework, and to evaluate the ability to reliably monitor body weight in such a setting. In addition to feasibility, the study seeks to determine whether relevant health gain parameters can be accurately captured by leveraging participant compliance data obtained through digital device usage. This approach aims to provide insight into both adherence and the quality of data collection in a decentralised environment. Another important objective is to investigate the impact of weight management interventions on health outcomes over the course of the study. By analysing longitudinal health data collected remotely, the research intends to evaluate the effectiveness of these programs in producing measurable improvements. Finally, the study includes an evaluation of participants’ reported satisfaction with the devices used, as well as their perspectives on the overall feasibility of the decentralised setup. Incorporating these user-reported outcomes ensures that the study not only addresses clinical effectiveness but also considers the practical and experiential dimensions of trial participation. Taken together, these objectives reflect a comprehensive effort to explore both the scientific and operational dimensions of conducting weight management research through decentralised clinical trial methodologies.

If the project may be relevant to citizens or patients you support (exclusively in Region Midtjylland), please share the project page and participation form. 

cross-sectorial COLLABORATION

The consortium is led by Monsenso and includes partners across academia, healthcare, industry, and innovation: Aarhus University, Research Unit for General Practice (FEAP), Bispebjerg Hospital, Steno Diabetes Center Aarhus, Aarhus Municipality, the Danish Technological Institute, the Alexandra Institute, the Copenhagen Institute for Futures Studies, Danish Life Science Cluster, Novo Nordisk, and Novartis.

PhaseV aims to deliver a scalable digital platform for effective decentralised recruitment, continuous data capture, and phase-V style real-world studies that can strengthen patient care and decision-making.

For more information about the project and its progress, visit the PhaseV website or the Danish Life Science Cluster project page, or follow Monsenso on LinkedIn.

 To learn more or explore a pilot or integration, book a demo or get in touch via our website.

Solution
AI creates individually tailored treatment for depression

AI creates individually tailored treatment for depression

Mar 28, 2023

A new innovation project “Personae” will provide easier access to personalised digital treatment for patients with depression through Monsenso’s digital health platform. The project leverages patient-reported outcomes and AI to screen patients and to deliver a treatment tailored to the individual patients’ needs.

According to the WHO, more than one billion people worldwide have mental disorders, but the number of individuals receiving help is alarmingly low. In Western Europe, for instance, only half of the citizens with anxiety or depression receive relevant treatment. At the same time, the healthcare system is challenged by a shortage of healthcare professionals.

Therefore, Innovation Fund Denmark is funding the development of a personalised treatment based on Monsenso’s digital health solution, which will leverage artificial intelligence to tailor the treatment to the individual patient’s needs.

Today, digital programs provide evidence-based treatment to citizens with depression, for example in the Danish clinic” Internetpsykiatrien”. Research shows that such programs have the same effect on citizens with mild to moderate depression as physical therapy sessions. The potential is huge, with thousands of citizens on waiting lists or receiving no relevant support at all. However, delivering a personalised intervention to everyone is challenging. Some patients benefit from a fully automated, digital treatment program, others need their treatment program supported by a psychologist, and yet other patients with complex life situations need physical meetings with their healthcare providers.

“The project enables us to use artificial intelligence, which, in collaboration with Monsenso’s digital health solution and the Internetpsykiatrien, can ensure that more people can quickly get access to the right treatment. This next generation of digital treatment will make it much easier to offer a fully or partially digital treatment that matches each individual’s needs,” says Kim Mathiasen, research director at the Center for Digital Psychiatry, who leads the Personae project.

”We see great potential in this project. It enables us to continue the development of our digital health solution and further validate it. It will improve the way we use people’s own health and behavioral data to keep them engaged, customise their treatment and support clinical decision-making at scale”, says Thomas Lethenborg, CEO at Monsenso.

”The unique, patient-reported data that will be generated from the screening and continuous use of Monsenso’s solution in Internetpsykiatrien is a fantastic foundation for development, training and validation of algorithms for automatisation of decision support and optimisation of treatment pathways”, says Dr. Pepijn Van de Ven, Senior Lecturer at Limerick University.

The primary ambition of the project is to develop intelligent adaptations of treatment content to match patients’ symptoms and life situations. The solution should be able to identify early signs of drop-out and support patients’ and healthcare providers’ decisions concerning treatment. The artificial intelligence solutions will be incorporated into both the public Internetpsykiatrien clinic, which the Center for Digital Psychiatry operates, and into the digital health solution of Monsenso.

The project is led by the Center for Digital Psychiatry, which, in Danish and international contexts, is a pioneer in internet-based therapy in terms of development, research, and operation. This project combines their research and extensive clinical experience with the competencies and commercial platform of Monsenso, as well as the unique competencies in artificial intelligence for mental health at the University of Limerick. 

Facts
Project title: Personae – Personalised Digital Treatment of Depression
Total budget: DKK 22.1 mio.
Innovation Fund Denmark investment: DKK 16.5 mio.
Net contribution to Monsenso: DKK 3.9 mio.
Duration: 4 years

About the partners
Center for Digital Psychiatry at Region Southern Denmark works to ensure that all Danes have easy and equal access to mental health. In a Danish and international context, the Center for Digital Psychiatry are frontrunners in the use of digital solutions for mental health promotion and psychiatric treatment and they are experts in matching the current needs of psychiatry with the right digital technology.

The University of Limerick, Department of Electronic & Computer Engineering, has high expertise in research and teaching in information and communication technology. The Department of Electronic & Computer Engineering is a leader in research on artificial intelligence for Internet-based therapy.

Odense University Hospital, the Danish Depression Association and the strategic innovation agency Is It a Bird are also involved in the project.

Further information:
Monsenso:
CEO
Thomas Lethenborg
Tel. +45 21 29 88 27
E-mail: lethenborg@monsenso.com 

Certified Adviser:
Norden CEF A/S
John Norden
Tel. +45 20 72 02 00
E-mail: jn@nordencef.dk

 

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