The period tracking app Clue has announced a new initiative to leverage its collective, anonymised health data to help close the diagnosis gap for the most common yet under-researched and underdiagnosed female health conditions.

With the new My Health Record feature within the Clue app, users will be able to input confirmed diagnoses for 21 different health conditions including endometriosis, polycystic ovary syndrome (PCOS), premenstrual dysphoric disorder (PMDD), uterine fibroids, bleeding disorders and anxiety disorders.

Clue is engaging with researchers from top institutions, such as the University of California, Berkeley, and the University of Exeter, and collaborating with the Menarche Menstruation Menopause and Mental Health (4M) consortium on the ways in which this unique dataset can be leveraged to help close the diagnosis gap in areas that have previously lacked large-scale data for research.

Launched in 2021, 4M facilitates collaborative interdisciplinary research into how menstruation and menopause interact with mental health.

Research projects planned for Clue’s Health Record data in 2024 include improving diagnostics for endometriosis and PMDD, exploring the impact of the menstrual cycle on ADHD, anxiety, and depression and shedding light on under-researched symptom patterns in early perimenopause.

“Together with our global user community, we are creating what will be the world’s largest data set that can match the menstrual and wider health symptom patterns of people with confirmed diagnoses with those who have the same patterns, but who don’t yet have a diagnosis,” said Audrey Tsang, Clue CEO.

“By working with top researchers from around the world to leverage this data, we believe we will be able to make significant progress to accelerate and improve diagnostics and support for people with these conditions.”

Gemma Sharp, associate professor in epidemiology in the School of Psychology at the University of Exeter, and founder and director of the 4M consortium, said: “I started the global 4M research consortium because I was astounded by the social stigma, lack of understanding and paucity of research in the field of women’s menstrual health, which is a big contributor to gender inequality. Half the world menstruates, and related health issues can have a major impact on quality of life, health and wellbeing.

 “Now, this new partnership between our global research consortium and Clue is a really exciting opportunity to conduct research at the intersection of two crucial areas: menstrual and mental health.

“This collaboration will allow us to gather and analyse data on a massive scale, enabling us to generate answers which will improve understanding of women’s health, and ultimately improve lives.”

Professor Kim Harley, associate professor at the University of California, Berkeley, said: “The impacts of perimenopause symptoms, including loss of sleep, hot flashes, mood and mental health changes, are coming to the fore as a major factor in economic and health equality.

“However, there is still a lot we don’t know about the very earliest stages of perimenopause, the frequency and severity of symptoms, and individual factors that increase symptoms. This is tied to the lack of real-time data on large populations of people experiencing this highly individual and often gradual process.

“Working with Clue and its new ‘perimenopause mode’ provides the opportunity to study and understand the perimenopausal process. Clue’s data is unique in that it covers poorly understood periods of people’s reproductive lives, including the transition from fertility to menopause, early onset menopause and the experiences of people at the beginning stages of this process before they would otherwise be clinically identified.

“Many people experience symptoms without understanding them as part of the perimenopause process and few people successfully receive clinical support for their symptoms. We hope that our research with Clue will help individual users understand more about this universal life stage.”

Currently, only one per cent of traditional biopharma R&D funding goes into female health conditions, despite women spending nearly twice as much on healthcare as men.

Conditions that disproportionately affect women, such as endometriosis, migraine and anxiety disorders, all attract much less funding relative to the disease burden, which considers the impact on the population in terms of quality of life, cost of care, and loss of productivity.

“What is politely called ‘the research gap’ is more of a research ‘canyon’ when it comes to female health, with the direct consequence that millions of women and people with cycles people are living with symptoms that could benefit from medical support, but too often it takes far too long for them to access that support and treatment,” explained Tsang, Clue CEO.

“We believe through this initiative we’ll be able to uncover insights and patterns that can be used to develop personalised insights to help people engage with their healthcare providers and accelerate the diagnosis process.”

She added: “We know data is power and agency when it comes to health and that it can play a critical role in making what is otherwise invisible, both visible and quantifiable.

“We’re excited to take the scale of Clue data and put it to work to specifically address the diagnosis gaps that cause so much frustration, confusion and pain. Having a diagnosis can mean validation, relief and most importantly, the opportunity to get the help and treatment one needs.”

To paint a picture of the current diagnosis gaps and delays for women and people with cycles:

• In 72 per cent of cases, women will wait longer than men to get a diagnosis for the same health conditions.

• One in 10 will have endometriosis, but only 40 per cent will be diagnosed, with seven to 12 years between the first onset of symptoms to the actual diagnosis.

• 90 per cent of women with PMDD are undiagnosed, with an average delay of 20 years before it is correctly identified.
• 70 per cent of women with PCOS are undiagnosed and for a third of those with the condition, it will take two years to diagnose. Almost half of people with this condition had to see more than three healthcare providers to get a diagnosis.
• One in three women with perimenopausal symptoms go undiagnosed  and middle-aged women are more likely to have their symptoms brushed off as mental health related.

As a Germany-based company, Clue says it adheres to the world’s strictest data privacy laws. Data tracked within the app, the company says, has long contributed to important scientific research helping to close the gender-data gap, to improve societal understanding of menstrual and reproductive health.

According to Clue, data is only used for research with the express consent of users – and research partners only work with anonymous data that cannot be traced back to any individual.

In a recent survey, 85 per cent of Clue users indicated that they wanted their anonymised data to be used for health research.