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.
Women 18-45 who have had type 1 diabetes for at least 12 months
Premenopausal with either menstrual cycles or currently using oral contraceptives
Women who are postmenopausal, pregnant, trying to become pregnant, or have had a hysterectomy
Parallel
Personalized modifications to treatment to address menstrual cycle effects on glycemia
Other interventionThe 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.
Glucose time in range
time spent with glucose 70-180mg/dL on continuous glucose monitor
Glucose standard deviation
standard deviation (mg/dL) of glucose on continuous glucose monitor
Mean glucose (mg/dL) pre-exercise
Mean glucose from continuous glucose monitor in response to exercise
Mean glucose (mg/dL) while exercising
Mean glucose from continuous glucose monitor in response to exercise
Mean glucose (mg/dL) over 24 hours after exercise
Mean glucose from continuous glucose monitor in response to exercise
Glucose standard deviation
standard deviation (mg/dL) of glucose on continuous glucose monitor
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University of Colorado, Denver
Lead sponsor
The Leona M. and Harry B. Helmsley Charitable Trust
Collaborator
