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

Type 1 Diabetes Clinical Trial

— MERIT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06297980
• Other study ID #: 23-1513
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2024
• Est. completion date: October 31, 2026

Study information

• Verified date: February 2024
• Source: University of Colorado, Denver
• Contact: JANET K SNELL-BERGEON, PhD, MPH
• Phone: 3037246762
• Email: Janet.Snell-Bergeon[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: October 31, 2026
• Est. primary completion date: October 31, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Hyperglycemia
• Hypoglycemia
• Menstruation Disturbances
• Type 1 Diabetes

Intervention

Other:
• Personalized 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.

Locations

Country	Name	City	State
United States	University of Colorado	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	The Leona M. and Harry B. Helmsley Charitable Trust

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose time in range	time spent with glucose 70-180mg/dL on continuous glucose monitor	3 months during randomization to intervention or standard care
Primary	Glucose standard deviation	standard deviation (mg/dL) of glucose on continuous glucose monitor	3 months during randomization to intervention or standard care
Secondary	Mean glucose (mg/dL) pre-exercise	Mean glucose from continuous glucose monitor in response to exercise	mean glucosewithin 5 minutes of beginning planned exercise bouts based on start time reported by study participant and/or accelerometer data
Secondary	Mean glucose (mg/dL) while exercising	Mean glucose from continuous glucose monitor in response to exercise	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)
Secondary	Mean glucose (mg/dL) over 24 hours after exercise	Mean glucose from continuous glucose monitor in response to 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)
Secondary	Glucose standard deviation	standard deviation (mg/dL) of glucose on continuous glucose monitor	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)
Secondary	Glucose standard deviation	standard deviation (mg/dL) of glucose on continuous glucose monitor	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)