Menstrual Cycle & Type 1 Diabetes Management

The Big Picture

Closing a Critical Gap in Diabetes Care for Women

What is the core challenge this study is trying to address?

Women with type 1 diabetes face a challenge that is often overlooked in clinical practice: the menstrual cycle. Hormonal fluctuations across the cycle directly affect insulin sensitivity, leading to significant glucose variability. Despite this, existing diabetes management tools and algorithms do not sufficiently account for these cyclical changes, leaving women without reliable guidance for adjusting their management across the month.

"Women with type 1 diabetes often experience significant glucose variability across the menstrual cycle due to hormonal fluctuations that affect insulin sensitivity. Currently, diabetes management tools and algorithms insufficiently account for these cyclical changes."

What does this study set out to prove?

The primary goal of DC Berne's Dr. Martina Rothenbühler and Stefanie Hossmann is to generate robust, real-world evidence on how cyclical hormonal changes affect glycemic control in women with type 1 diabetes. By continuously collecting physiological, behavioral, and glucose data over an extended period, the research team aims to understand how the menstrual cycle impacts glucose regulation in daily life. The aim is for those findings to inform improved clinical recommendations and algorithm adjustments, and ultimately to reduce the management burden for women with type 1 diabetes.

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The Study Blueprint

A Multinational, Real-World Cohort at Scale

How large is the study, and where is it being conducted?

The study enrolls 350 women with type 1 diabetes across five countries in Europe and North America: Germany, Switzerland, Denmark, the United Kingdom, and the United States. The total study duration is approximately 18 months, with each participant contributing six months of data. Conducting the study across multiple countries allows the team to collect data from diverse populations and healthcare settings, which strengthens the applicability of the findings.

Why a wearable, and why the Garmin Venu 3 specifically?

Continuous, real-world data collection is central to this study. A wearable allows the research team to capture physiological signals in participants' everyday environments, including during sleep, exercise, and daily routines, without requiring clinic visits. At this scale, spanning 350 participants across five countries over 18 months, remote data collection makes consistent participation practical.

The team selected the Garmin Venu 3 because of its aesthetic appeal, which supports long-term adherence and participant compliance. The integration with Labfront enables CGM data to be displayed directly on the watch face. This is particularly important for this study population, as it provides a seamless, user-friendly experience while ensuring that behavioral and glucose data are collected in sync.

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The Methodology

Layering Physiological, Behavioral, and Glucose Data

Which physiological signals are at the centre of the analysis?

The study is built around three core physiological metrics captured continuously via the Garmin Venu 3: physical activity, sleep, and heart rate variability (HRV). These parameters are each analyzed in relation to glucose dynamics across the menstrual cycle, giving researchers a detailed view of how behavior and physiology interact with glycemic control over time.

• Continuous Glucose Monitoring (CGM) integrated through Labfront
• Physical Activity via Garmin Venu 3
• Sleep via Garmin Venu 3
• Heart Rate Variability (HRV) via Garmin Venu 3
• Menstrual Cycle Information collected alongside wearable data
• Behavioral Data additional data collected in parallel

How is CGM data being collected alongside the wearable?

CGM values are collected as a parallel data stream alongside the Garmin-derived physiological data. The Labfront integration enables CGM readings to be displayed directly on the Venu 3 watch face, which creates a more seamless experience for participants. This also means glucose data and behavioral data are collected in sync, supporting more accurate analysis of how activity, sleep, and HRV relate to glucose changes across the menstrual cycle.

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The Impact

Building the Evidence Base for Better Diabetes Care

Where does the study stand today?

The study has recently started, and no specific trends or findings have emerged from the data yet. Data collection is underway across the participating countries. The 18-month study window gives the team sufficient time to collect continuous data across the full cohort before analysis begins.

What does success look like for this research?

The research team's goal goes beyond generating data. The aim is for the findings to lead to improved clinical recommendations and algorithm adjustments that better account for cyclical hormonal changes. If successful, this could significantly reduce the management burden for women with type 1 diabetes and improve their quality of life.

This research sits within a broader effort to close the gap in women's health data. Better evidence on how the menstrual cycle affects type 1 diabetes management can inform more personalized, effective care for a population that has historically been underserved by diabetes research.

"We hope that the findings will lead to improved clinical recommendations and algorithm adjustments that better account for cyclical hormonal changes, significantly reducing the management burden and improving quality of life for women with type 1 diabetes."

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Study Participation

Are you a woman with type 1 diabetes?

This study is actively recruiting participants across Germany, Switzerland, Denmark, the United Kingdom, and the United States. If you're interested in taking part, scan the QR code to find out more.

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