Impact of MEnstruation on Glycemic Response and Exercise In Females With Type 1 Diabetes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 150
- Locations
- 2
- Primary Endpoint
- Glucose standard deviation
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Personalized treatment
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.
Intervention: Personalized modifications to treatment to address menstrual cycle effects on glycemia (Other)
Standard Care
In this arm, women will continue with their usual insulin dose, food intake and glycemic algorithms as determined by their provider
Outcomes
Primary Outcomes
Glucose standard deviation
Time Frame: 3 months during randomization to intervention or standard care
standard deviation (mg/dL) of glucose on continuous glucose monitor
Glucose time in range
Time Frame: 3 months during randomization to intervention or standard care
time spent with glucose 70-180mg/dL on continuous glucose monitor
Secondary Outcomes
- 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 (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))
- 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))
- 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))