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New treatment option for Type 1 Diabetes
Official title Exercise and the Menstrual Cycle in Type 1 Diabetes
ClinicalTrials.gov ID: NCT05188014
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50, women only
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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.)
The study team makes the final eligibility decision.
Where it's taking place
- Edmonton, Alberta, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Edmonton, Alberta, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.