Diabetes Management Among Women Using an AID System: a Mixed Method Study (NCT07696780) | Clinical Trial Compass
CompletedNot Applicable
Diabetes Management Among Women Using an AID System: a Mixed Method Study
Switzerland69 participantsStarted 2024-10-01
Plain-language summary
Automated insulin delivery (AID) systems substantially improve diabetes management in people with type 1 diabetes but do not account for menstrual cycle related changes in insulin sensitivity. As a result, many menstruating individuals rely on manual adjustments, such as entering fake carbohydrates, modifying insulin settings, or changing basal rates, to maintain glycemic control. This study aims to systematically characterize these manual adjustment strategies, estimate how frequently they are used across the menstrual cycle, and explore their perceived burden, effectiveness, and implications for the development of future AID algorithms that better address menstrual cycle related insulin variability.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* At least 18 years old
* Good knowledge of English or German
* Type 1 diabetes since \>3 years
* Regular menstrual cycle (24-35 days) since \>2 years
* Using one of the following AID systems: Tandem t-slim:X2 with Control-IQ; Medtronic 780G; DBLG1 (Kaleido, AkkuChek Insight); CAMAPS FX (Ypsopump, Dana); Omnipod 5; AAPS DIY; IAPS DIY; Loop DIY
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Type of manual adjustment to AID settings to manage menstrual cycle related changes in insulin requirement
Timeframe: One full menstrual cycle (24 - 35 days)