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

Not Applicable

Recruiting

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

Interventions: Other: Personalized modifications to treatment to address menstrual cycle effects on glycemia

Brief 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.

Detailed Description: The overall goal of this project is to further understand the impact of hormonal status on glycemic metrics and to test personalized changes to insulin dosing, through implementing the following specific aims:

Specific Aim 1: Using CGM, examine glucose levels among women with T1D by menstrual cycle phase over a three month period to establish baseline glycemic variability, to identify personalized patterns of glycemic control across the menstrual cycle phase, and to test glycemic responses to acute bouts of aerobic, interval and resistance training.

Specific Aim 2: Using the data from the observational period, examine patterns of glycemic variability by menstrual cycle phase in order to determine the appropriate alteration to insulin delivery needed to improve glycemic control across the menstrual cycle among women with T1D

Specific Aim 3: Test an intervention that includes up to four personalized adjustments to food intake, insulin dose and glycemic algorithms by menstrual cycle phase in a randomized intervention and control group. We will also examine responses to daily activity, planned exercise activities, and acute bouts of aerobic, interval and resistance exercise.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Personalized treatment	Personalized modifications to treatment to address menstrual cycle effects on glycemia	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.

Primary Outcome Measures

Name	Time	Method
Glucose standard deviation	3 months during randomization to intervention or standard care	standard deviation (mg/dL) of glucose on continuous glucose monitor
Glucose time in range	3 months during randomization to intervention or standard care	time spent with glucose 70-180mg/dL on continuous glucose monitor

Secondary Outcome Measures

Name	Time	Method
Mean glucose (mg/dL) pre-exercise	mean glucosewithin 5 minutes of beginning planned exercise bouts based on start time reported by study participant and/or accelerometer data	Mean glucose from continuous glucose monitor in response to exercise
Mean glucose (mg/dL) over 24 hours after exercise	mean glucose during the 24 hours after beginning planned exercise bouts (from participant reported or acceleromater data based start of exercise to 24 hours later)	Mean glucose from continuous glucose monitor in response to exercise
Glucose standard deviation	glucose standard deviation during the luteal menstrual cycle phase (starting from the day of a positive home ovulation test to the start of the next period reported by participant, for a maximum of 30 days if no next period begins)	standard deviation (mg/dL) of glucose on continuous glucose monitor
Mean glucose (mg/dL) while exercising	mean glucose measured every 5 minutes while actively exercising (between exercise start and end times as reported by study participant or based on accelerometer data, from a minimum of 5 minutes to up to 480 minutes)	Mean glucose from continuous glucose monitor in response to exercise