Impact of MEnstruation on Glycemic Response and Exercise In Females With Type 1 Diabetes

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorUniversity of Colorado, Denver

About this trial

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

Qualifiers

Women 18-45 who have had type 1 diabetes for at least 12 months

Premenopausal with either menstrual cycles or currently using oral contraceptives

Disqualifiers

Women who are postmenopausal, pregnant, trying to become pregnant, or have had a hysterectomy

Trial design

Treatments tested in this trial

  • Personalized modifications to treatment to address menstrual cycle effects on glycemia

Treatment groups

150 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Colorado, Denver

Lead sponsor

The Leona M. and Harry B. Helmsley Charitable Trust

Collaborator