![\"\"](\"https:\/\/www.dcberne.com\/wp-content\/uploads\/2025\/09\/DCB_TIMES_wort-bild-marke.svg\")
<\/a><\/p>\nThis could ultimately help women with T1D achieve better health outcomes and improve their quality of life.<\/p>\n
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Premenopausal women with type 1 diabetes (T1D) often experience changes in blood sugar control related to their menstrual cycle. These natural hormone fluctuations can make diabetes management difficult, especially since current AID systems are not designed to adjust insulin delivery in response to these monthly hormonal changes.<\/p>\n
The TIMES study was developed to gain robust scientific insights into how insulin requirements and blood glucose control change during the menstrual cycle. The multinational study is being conducted in a decentralized manner and includes a total of 350 women, approximately 50 each in Switzerland, Denmark, the UK, the US, and Germany. As this is a decentralized study, all study-related activities take place online or at the participants’ homes. It is not necessary to visit a clinic or medical center.<\/p>\n
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By collecting real-world data (data from everyday life) from participants’ automated insulin delivery systems (AID systems), we can obtain much of the information needed to understand how insulin requirements and blood sugar levels fluctuate during the menstrual cycle. This is supplemented by data that participants themselves enter in surveys, such as information on menstrual cycles, symptoms and lifestyle habits.<\/p>\n
Our goal is to identify typical patterns in insulin requirements and blood glucose levels, including time in range, hypo- and hyperglycaemia, during the different phases of the menstrual cycle. We also want to understand which factors, such as premenstrual symptoms or the level of physical activity, significantly influence or characterise these fluctuations.<\/p>\n
We are conducting the study in accordance with Swiss law. We also comply with all internationally recognised guidelines. The responsible ethics committee has reviewed and approved the research project.<\/p>\n
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This study is conducted exclusively from home, meaning that all study-related activities can be completed at home. We ask participants to collect data on their diabetes management and menstrual cycle over six menstrual cycles (participation can therefore last up to seven months). You will be asked to complete several questionnaires. You will also be asked to provide or upload data from your AID system, including information on glucose levels, insulin doses and carbohydrate intake. We will provide you with a Garmin smartwatch, which you should wear throughout the study (including at night), and you will need to perform ovulation tests to determine your ovulation in each cycle (up to 10 ovulation tests per month).<\/p>\n