RecruitingNot Applicable

Exercise and the Menstrual Cycle in Type 1 Diabetes

Canada15 participantsStarted 2022-03-15

Plain-language summary

Female participants with type 1 diabetes using oral contraceptives will be asked to wear a continuous glucose monitor for at least three days on two separate occasions (once during the last week of active pills and once during the no pill/placebo pill phase of the menstrual cycle). An exercise session (45 minutes of aerobic exercise at 60% VO2peak on a cycle ergometer) will take place at 5 pm on the second day of glucose monitoring.

Who can participate

Age range

18 Years – 50 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: * type 1 diabetes diagnosed for at least 1 year * regular menses * using monophasic oral contraceptives * residing in Edmonton, Alberta and able to visit the lab at the University of Alberta Exclusion Criteria: * HbA1c \> 9.9% * frequent and unpredictable hypoglycemia * change in insulin management strategy within two months of the study * use of an automated insulin delivery system * blood pressure \> 140/95 * history of cardiovascular disease * severe peripheral neuropathy * active proliferative retinopathy * use of medications (other than insulin) that would affect blood glucose levels * any musculoskeletal condition that would contraindicate exercise (e.g. sprain, strain, joint injury, etc.)

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

Blood glucose

Timeframe: Pre-exercise (0 minutes), post-exercise (45 minutes) and 1 hour post-exercise

Trial details

NCT IDNCT05188014

SponsorUniversity of Alberta

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06-30

View on ClinicalTrials.gov More Type 1 Diabetes trials