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NCT06297980
Impact of MEnstruation on Glycemic Response and Exercise In Females With Type 1 Diabetes
Conditions: Type 1 Diabetes, Hypoglycemia, Hyperglycaemia Due to Type 1 Diabetes Mellitus, Menstruation Disturbances
Sex: Female
Ages: 18 Years – 45 Years
Healthy volunteers: No
Phase: NA
Enrollment: 150
Sponsor: University of Colorado, Denver
Location: University of Colorado Aurora Colorado
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT06297980). StuddyBuddy aggregates publicly available trial information.
