Menstrual Cycle Study: Results published in Diabetes Care

Menstrual Cycle Study: Results published in Diabetes Care

Menstrual Cycle Study: Results published in Diabetes Care

DCB and Tidepool investigated how menstrual cycle phases relate to insulin needs, glycemic outcomes and insulin sensitivity in people with type 1 diabetes using automated insulin delivery systems.

Menstrual Cycle Study

The Menstrual Cycle Study was conducted in collaboration between Tidepool and the Diabetes Center Berne (DCB). The retrospective decentralized study analysed real-world data donated by 77 menstruating adults with type 1 diabetes using automated insulin delivery systems.

In total, the dataset covered 380 menstrual cycles and 10,107 days of data from continuous glucose monitoring, insulin delivery, carbohydrate intake and menstrual cycle tracking.

The findings have been published in Diabetes Care, a journal of the American Diabetes Association.

Study results

The study investigated how insulin needs, glycemic outcomes and insulin sensitivity vary across menstrual cycle phases. Cycle phase-specific variation in insulin sensitivity was estimated using a hierarchical Bayesian state-space model.

The results show systematic phase-dependent variation in insulin requirements, carbohydrate intake, glycemic outcomes and model-derived insulin sensitivity.

menstruating adults with type 1 diabetes included in the analysis

menstrual cycles covered by the real-world dataset

days of data from CGM, insulin delivery, carbohydrate intake and cycle tracking

Visual abstract

PARTICIPANTS AND DATA

77 adults, 380 cycles

Real-world AID, CGM, insulin delivery, carbohydrate intake and menstrual cycle tracking data.

CYCLE PHASES

Early follicular phase (period) to midluteal phase

The analysis compared phase-specific patterns across the menstrual cycle.

MAIN SIGNAL

Insulin sensitivity and glucose outcomes varied by phase

  • Higher insulin sensitivity early in the cycle
  • Higher insulin needs around the midluteal phase
  • Individual variability remained substantial

Key findings

Early follicular phase (period)

Model-derived estimates indicated the highest population-level insulin sensitivity in the early follicular phase, at +2.6% relative to the population average.

Midluteal phase

Total daily insulin dose and carbohydrate intake increased across the cycle and were elevated around the midluteal phase. Model-derived insulin sensitivity was lowest in the midluteal phase, at -2.6% relative to the population average.

Luteal phases

Mean glucose and time above range were higher, while time in range and time in tight range were lower during parts of the luteal phase.

Across individuals

Most participants broadly followed the population-level trend: 84.7% showed above-average insulin sensitivity in the early follicular phase and below-average insulin sensitivity in the midluteal phase, but the magnitude varied considerably.

Why this matters

The findings suggest that menstrual cycle-related physiology remains relevant for glycemic regulation, even in people using automated insulin delivery systems.

They also suggest that current automated insulin delivery systems do not fully compensate for menstrual cycle-related fluctuations in insulin needs and glycemic outcomes.

What the study does not show

The study does not provide individual treatment recommendations and does not suggest that menstrual cycle effects are the same for everyone. As an observational study, it identifies patterns and variability, but causal conclusions remain limited.

Building on this work, the TIMES study is designed to determine cycle phases more precisely using ovulation tests and to capture additional factors that may influence insulin sensitivity.

Publication

Hossmann S, Friedman M, Lizoain A, Caduff M, Braunack-Mayer V, Burlando L, Lal RA, Cengiz E, Braune K, Reger-Tan S, Knopf A-C, Zueger T, Khan-Gallo S, Rothenbuehler M, et al.

Effects of menstrual cycle on insulin sensitivity in type 1 diabetes: an observational study of individuals using an automated insulin delivery system.

Diabetes Care. 2026;49(9):1673-1680. DOI: 10.2337/dc26-0692

Building on this research: the TIMES study

Building on these findings, DCB is continuing this line of research through the TIMES study, which investigates how insulin requirements change across the menstrual cycle in women with type 1 diabetes.

TIMES will help define cycle phases more precisely through ovulation testing and collect additional contextual information that may influence insulin sensitivity, supporting a more detailed understanding of individual variability.

Contact

Menstrual Cycle Study Team

The RIPPLE study

A Tidepool Big Data Donation Project Study that brings together diabetes
device data, wearable signals, and health survey responses to explore how
everyday aspects of life, like sleep, activity, stress, and hormonal changes, can
create ripple effects across the diabetes spectrum.

Your participation helps build one of the most comprehensive real-world
pictures of life with diabetes across the full spectrum of experience, informing
better tools for the whole community.

In collaboration With Oura, eligible participants receive a complimentary
refurbished Oura Ring Gen3.

Study Partners

The Menstrual Cycle Study was conducted by Tidepool and the Diabetes Center Berne, with contributions from international research partners.

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SPN-005 – Pilot study on painless glucose monitoring

SPN-005 – Pilot study on painless glucose monitoring

SPN-005 – Pilot study on painless glucose monitoring

Towards painless, needle-free glucose monitoring for people with Type 1 Diabetes.

Project description:
For people with Type 1 Diabetes, multiple daily finger pricks to check blood sugar levels are common practice. This project evaluates a novel non-invasive technology developed by Liom Health AG, which uses light and artificial intelligence to measure glucose levels through the skin in real time — without finger pricks.

Methodology:
In a pilot study with 21 participants, a carefully controlled sequence of blood glucose fluctuations was induced to assess the device’s accuracy. Conventional blood glucose measurements and continuous glucose monitoring (CGM) systems were used in parallel.

Results:
The device readings showed good agreement with established methods, with most measurements falling within clinically acceptable ranges. No health risks or technical issues were observed.

Conclusion:
The study indicates that painless glucose monitoring without fingersticks or CGM could be feasible. However, further research is required to improve accuracy and reliability before market readiness.

Partner: Liom Health AG (formerly Spiden AG), University Clinic for Diabetology, Endocrinology, Nutritional Medicine & Metabolism (UDEM)
Category: Clinical pilot study
Year: 2023-2024

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AID-JUNCT study: GIP/GLP-1RA as Adjunctive to Automated Insulin Delivery

AID-JUNCT study: GIP/GLP-1RA as Adjunctive to Automated Insulin Delivery

AID-JUNCT study: GIP/GLP-1RA as Adjunctive to Automated Insulin Delivery

Findings from a prospective, randomized clinical study

Innovative approaches to combination therapy in type 1 Diabetes

Glycemic control in type 1 diabetes (T1D) remains a challenge, with ~32% of adults in Switzerland achieving an A1c target of <7%. The dual glucagon-like peptide-1 receptor agonists (GLP-1RAs) and glucose-dependent insulinotropic polypeptide (GIP)/GLP-1RAs has emerged as promising therapy in T1D. Retrospective studies have shown people with T1D can significantly improve glycemic control with a reduction in insulin dose and body weight when long-acting GLP-1RAs or GIP/GLP-1RAs are added to insulin therapy.

This study will assess glycemic control in people with T1D on a stable dose of long-acting GIP/GLP-1RA (Tirzepatide) as an adjuvant therapy to automated insulin delivery (AID). We are conducting a prospective, parallel, open-label, randomized clinical trial to test the hypothesis that available AID systems combined with GIP/GLP-1RA will lead to safe and more efficacious glycemic control than Standard of Care (SoC) during the assessment period. The outcome of this study will provide unique data about the safety and efficacy of using GIP/GLP1-RA as adjuvant therapy to AID systems.


Sponsor: Prof. José García-Tirado, PhD – University of Berne
Principal investigator: PD Dr. med. Thomas Züger, Chief Physician – Kantonsspital Olten
PhD student: Dr. med. Maria Carolina Fragozo-Ramos
Funding: Internal funds

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Obesogenic microbiota Project

Obesogenic microbiota Project

Obesogenic microbiota Project

Exploring the connection: obesity, gut microbiome, and metabolic health

Cause and effect relationship between obesity and gut microbiome

Global rises in metabolic diseases such as obesity and diabetes pose severe medical and socio-economic threats, influenced by a variety of both genetic and environmental factors. Chronic inflammation links these diseases, suggesting an impact on the immune system. The human intestinal flora, especially the metabolic products it produces, appear to play a role in the development of obesity and diabetes.

To understand the underlying mechanisms, our project utilizes innovative methods (gnotobiotics, metagenomics and metabolomics) to explore the relationship between gut flora, metabolism and immune function. By unraveling these relationships, we aim to lay the foundation for innovative strategies to prevent and treat these diseases.

Project team: Melanie Scalise, June Stone
Funding: SNSF

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Bacterial metabolites modulating Immune Function

Bacterial metabolites modulating Immune Function

Bacterial metabolites modulating Immune Function

Exploring microbial metabolites and immune activation

Unveiling the role of bacterial metabolites in dendritic cell function

The human gut microbiota, a complex and dynamic community of microorganisms residing in our digestive tract, plays a pivotal role in health and disease. Emerging research reveals a fascinating interplay between the gut microbiota, the immune system, and metabolism. The gut microbiome engages in a constant dialogue with immune cells, educating and regulating them, which in turn maintains gut health and guards against pathogens. This project aims to unravel the hidden mechanisms underlying the interactions between bacterial metabolites in the microenvironment and the activation of immune cells, by in particularly focusing on the impact of bacterial metabolites on dendritic cell metabolism and biological function. Preliminary data showed that bacterial metabolites are highly produced by bacteria expanding logarithmically and it can be sensed by DCs, fueling their activation. A lot of questions have still to be answered…

Project team: Andrea Celoria
Funding: SNSF

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