Clinical trial NCT06297980: Impact of MEnstruation on Glycemic Response and Exercise In Females With Type 1 Diabetes
Official title: Impact of MEnstruation on Glycemic Response and Exercise In Females With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 1 Diabetes
Hypoglycemia
Hyperglycaemia Due to Type 1 Diabetes Mellitus
Menstruation Disturbances
Keywords: type 1 diabetes
menstrual cycle
exercise
hypoglycemia
hyperglycemia
glucose control
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: The Leona M. and Harry B. Helmsley Charitable Trust
First posted: 2024-03-07
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This will be a parallel group randomized control trial of a personalized glucose control intervention to target changes in glycemic control related to the menstrual cycle that are identified during a 3 month observational period.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Glucose time in range
timeFrame: 3 months during randomization to intervention or standard care
measure: Glucose standard deviation
timeFrame: 3 months during randomization to intervention or standard care
Secondary outcomes:
measure: Mean glucose (mg/dL) pre-exercise
timeFrame: mean glucosewithin 5 minutes of beginning planned exercise bouts based on start time reported by study participant and/or accelerometer data
measure: Mean glucose (mg/dL) while exercising
timeFrame: 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)
measure: Mean glucose (mg/dL) over 24 hours after exercise
timeFrame: 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)
measure: Glucose standard deviation
timeFrame: glucose standard deviation during the follicular (starting day one of the menstrual period as self-reported by study participant through a positive home test for ovulation by participant, or for a maximum of 30 days if no positive ovulation test)
measure: Glucose standard deviation
timeFrame: 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)
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: JANET K SNELL-BERGEON, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: