Impact of MEnstruation on Glycemic Response and Exercise In Females With Type 1 Diabetes (NCT06297980) | Clinical Trial Compass
RecruitingNot Applicable
Impact of MEnstruation on Glycemic Response and Exercise In Females With Type 1 Diabetes
United States150 participantsStarted 2024-03-24
Plain-language summary
The objectives of this study are to examine how sex hormones (use of hormonal birth control, menstrual cycle phase) impact glycemic control among women with type 1 diabetes (T1D), and to test adjustments to insulin dosing and food intake to ameliorate cycle-related glycemic variability. A secondary aim is to examine how the menstrual cycle and use of hormonal birth control impact patient-reported outcomes and glycemic responses to physical activity.
Who can participate
Age range
18 Years – 45 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:
* Women 18-45 who have had type 1 diabetes for at least 12 months
* Premenopausal with either menstrual cycles or currently using oral contraceptives
Exclusion Criteria:
* Women who are postmenopausal, pregnant, trying to become pregnant, or have had a hysterectomy
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.
1This trial is specifically studying how the menstrual cycle affects blood sugar control during exercise in females with type 1 diabetes — given my own history with glucose fluctuations around my period, do you think my current patterns would make me a good candidate to discuss enrolling in this study?
2The trial is tracking 'glucose time in range' and 'glucose standard deviation' across the menstrual cycle — can you explain what those measurements mean for my day-to-day diabetes management, and whether my current CGM or glucose monitoring setup would be compatible with what the study requires?
3Since this is a Phase NA study focused on understanding how menstruation affects blood sugar and exercise response, rather than testing a new treatment, what does that mean for any direct benefit to me versus contributing to research that might help others in the future?
4The trial involves exercise testing alongside glucose monitoring across different phases of the menstrual cycle — how demanding would the exercise components likely be, and are there any safety concerns around hypoglycemia during those sessions that I should weigh before considering participation?
5Are there standard-of-care approaches or adjustments — like insulin dose timing or carbohydrate strategies around my cycle — that you'd recommend I try first, or would participating in this observational study complement rather than replace those conversations?
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
Glucose time in range
Timeframe: 3 months during randomization to intervention or standard care
2
Glucose standard deviation
Timeframe: 3 months during randomization to intervention or standard care