RecruitingNot ApplicableNCT06297980

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


Sponsor

University of Colorado, Denver

Enrollment

150 participants

Start Date

Mar 15, 2024

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Inclusion Criteria2

  • 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 Criteria1

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

Interventions

OTHERPersonalized modifications to treatment to address menstrual cycle effects on glycemia

The study physician will examine glucose patterns measured using continuous glucose monitoring over a 3 month observational period to identify hypo- or hyperglycemia related to menstrual cycle phase or exercise, and will provide changes to insulin basal or bolus rates, carbohydrate ratios, post-exercise food intake or use of sleep mode on automated insulin delivery systems.


Locations(1)

University of Colorado

Aurora, Colorado, United States

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NCT06297980


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