Impact of MEnstruation on Glycemic Response and Exercise In Females With Type 1 Diabetes
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: f
View:
• Women 18-45 who have had type 1 diabetes for at least 12 months
• Premenopausal with either menstrual cycles or currently using oral contraceptives
Locations
United States
Colorado
University of Colorado
RECRUITING
Aurora
Contact Information
Primary
JANET K SNELL-BERGEON, PhD, MPH
Janet.Snell-Bergeon@cuanschutz.edu
3037246762
Backup
Catherine Chartier-Logan, MPH
Catherine.Chartier-Logan@cuanschutz.edu
3037247505
Time Frame
Start Date: 2024-03-15
Estimated Completion Date: 2026-10-31
Participants
Target number of participants: 150
Treatments
Experimental: Personalized treatment
We will test an intervention that includes up to four personalized adjustments to food intake, insulin dose and glycemic algorithms by menstrual cycle phase, based on the three months of observational data collected.
No_intervention: Standard Care
In this arm, women will continue with their usual insulin dose, food intake and glycemic algorithms as determined by their provider
Related Therapeutic Areas
Sponsors
Collaborators: The Leona M. and Harry B. Helmsley Charitable Trust
Leads: University of Colorado, Denver