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

Locations

1
University of Colorado80045, AuroraColorado, United States

Sponsors and collaborators

University of Colorado, Denver

Lead sponsor

The Leona M. and Harry B. Helmsley Charitable Trust

Collaborator