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

Type 1 Diabetes Hypoglycemia Hyperglycaemia Due to Type 1 Diabetes Mellitus Menstruation Disturbances

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

Plain Language Summary

Simplified for easier understanding

This study looks at how the menstrual cycle affects blood sugar levels and the body's response to exercise in women with type 1 diabetes, with the goal of developing better exercise recommendations tailored to hormonal fluctuations. **You may be eligible if...** - You are a woman aged 18–45 with type 1 diabetes diagnosed at least 12 months ago - You are premenopausal and have regular menstrual cycles or are currently using oral contraceptives **You may NOT be eligible if...** - You are postmenopausal - You are pregnant, trying to become pregnant, or have had a hysterectomy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.