Examining how menstruation affects blood sugar control and exercise in women with type 1 diabetes
Impact of MEnstruation on Glycemic Response and Exercise In Females With Type 1 Diabetes
This study tests how hormonal changes during the menstrual cycle affect blood sugar control and exercise in women with type 1 diabetes to see if adjusting insulin and food intake can help improve their management.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT06297980 on ClinicalTrials.gov |
What this trial studies
This study investigates the influence of hormonal changes during the menstrual cycle on glycemic control in women with type 1 diabetes. It aims to identify personalized patterns of glycemic variability and test adjustments to insulin dosing and food intake based on menstrual cycle phases. Participants will use continuous glucose monitoring (CGM) to track glucose levels over three months and will undergo a randomized intervention to assess the effectiveness of personalized treatment modifications. The study also evaluates how these hormonal factors affect responses to different types of physical activity.
Who should consider this trial
Good fit: Ideal candidates are premenopausal women aged 18-45 with a diagnosis of type 1 diabetes for at least 12 months.
Not a fit: Patients who are postmenopausal, pregnant, trying to become pregnant, or have had a hysterectomy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved glycemic control and better health outcomes for women with type 1 diabetes by personalizing treatment based on menstrual cycle effects.
How similar studies have performed: While the specific focus on menstrual cycle effects in type 1 diabetes is relatively novel, previous studies have shown success in personalized diabetes management approaches.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Aurora, Colorado
- University of Colorado — Aurora, Colorado, United States (Recruiting)
Study contacts
- Principal investigator: JANET K SNELL-BERGEON, PhD, MPH — University of Colorado, Denver
- Study coordinator: JANET K SNELL-BERGEON, PhD, MPH
- Email: Janet.Snell-Bergeon@cuanschutz.edu
- Phone: 3037246762
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.