Menstrual Cycle Study
Together, let’s better understand clinically important sex and gender differences to improve outcomes for women living with type 1 diabetes.
Join Diabetes Center Berne (DCB) and Tidepool as we conduct a study to identify changes in insulin requirements and glucose levels throughout the menstrual cycle for people with type 1 diabetes.
We are looking for people who:
- are living with type 1 diabetes
- currently have a menstrual cycle
- use a CGM and insulin pump or smart pen for most of your insulin delivery
- are willing to share anonymized diabetes data and menstrual cycle data
- are 18 years or older
- are a resident of the United States.
About this Study
With this study, the teams at DCB and Tidepool aim to assess differences in insulin requirements and glycemic control parameters across the different phases of the menstrual cycle. This study will help us understand the relationship between menstrual cycles and insulin-dependent diabetes with the goal of supporting the development of tools and products to lower the burden of diabetes management throughout the menstrual cycle.
Study Requirements and Expectations
This study is recruiting menstruating people with type 1 diabetes who use some form of continuous glucose monitoring in conjunction with an insulin pump or smart pen over the age of 18 and residents of the United States.
Participation in this project will include:
- Completing the following screener/questionnaire, which asks you questions about your diabetes management and reproductive history
- If you are eligible for this study, we will ask you to upload CGM, insulin pump, and menstrual cycle data
- Your consent that we are allowed to use your anonymized data for research.
Before beginning this survey, please make sure you have your diabetes data uploaded to Tidepool. You will need to be using a computer to upload this data.
Data privacy & Anonymization
- Tidepool and DCB pledge to conduct this research with the highest level of integrity and responsibility, ensuring the protection of participants’ rights, privacy and well-being.
- Data will be collected in an anonymized manner. Participants will not be asked any questions that can be used for identification.
- Participants will receive clear instructions from Tidepool on how to remove device identification and manufacturer information from their data.
- Automized central data monitoring will be implemented to identify potential identifiable data and removed if any identification comes through.
- Please find instructions for exporting and anonymizing your data from Tidepool here.
Frequently Asked Questions
How will my data be used?
Your data will be used in analysis by the DCB team that aims at quantifying insulin requirements, parameters of glycemic control per menstrual cycle phase. The differences will be estimated using a mixed effects model to account for the fact that menstrual cycles are nested within women and that every woman might experience a different pattern. We plan to publish the findings from our data analysis. The report will not include any identifying information about you or your data. Depending on the results, further research will be done and your data might contribute to product improvements and product development that will help to lower the burden of diabetes management throughout the menstrual cycle in millions of people with a menstrual cycle.
Where will my data be stored?
The anonymous data is collected and stored in REDCap, a secure web application stored on servers in Switzerland. REDCap is compliant with the US Federal Information Security Management Act (FISMA), the US Health Insurance Portability and Accountability Act (HIPAA), the European General Data Protection Regulation (GDPR) and the Swiss Federal Act on Data Protection (FDAP). The anonymous data is stored, validated and analyzed according to DCB standard operational procedures (SOPs).
What are the risks associated with this study?
All collected data will be stored securely. However, there is always a minimal risk that someone who should not have access to this data gets access without permission such as in the rare event of a data breach. The risk is minimized at different levels: DCB cares about IT security and regularly audits its IT architecture including professional penetration attempts. In addition, since the submitted data is anonymous, it is not possible to link the data to its donor.
Is there also a risk that my data can be re-identified if I haven’t removed all the identifying information completely?
To minimize the risk of re-identification, DCB creates a unique, anonymous identifier that will be assigned to each participant. Our team takes steps to continuously assess the quality of all collected data during the study, including central data monitoring and de-identification mechanisms in case of incomplete de-identification.
About the study partners
DCB supports ideas and projects in the field of diabetes technology worldwide by providing expertise, access to clinical research facilities and its own laboratories, as well as financial resources. The goal is to bring them a big step closer to market entry in a collaborative partnership. The work of the DCB is non-profit – the goals are new insights and innovations around diabetes management as well as a vibrant community.
Tidepool is a 501(c)(3) nonprofit organization. We were founded by people with diabetes, caregivers, and leading healthcare providers committed to helping all people with insulin-requiring diabetes safely achieve great outcomes through more accessible, actionable, and meaningful diabetes data.
Get support
If you have further questions about the research, how your data will be used, please contact menstrual.cycle@dcberne.com.
If you need help downloading your data from Tidepool or have questions about anonymizing your diabetes data, please contact Tidepool’s support team at support+tpp@tidepool.org.
If you are interested in partnerning on women’s health projects with Tidepool please contact tpp@tidepool.org.
If you want to access Tidepool’s instructions for anonymization, please follow the link here.
Interested in the study results?
Submit your contact details below to receive news about the project:
DCB Research AG
Freiburgstrasse 3
3010 Bern
Switzerland