NCT Number: NCT06297980
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.
Interested in participating?
Request Info18 year–45 year
Female
Interventional
Not applicable
Aurora, Colorado, 80045, United States
Location status: Recruiting
Bryan Bergman, PhD
SUB_INVESTIGATOR
Catherine Chartier-Logan, MPH
CONTACT
Cristy Geno, PhD
SUB_INVESTIGATOR
JANET K SNELL-BERGEON, PhD
CONTACT
Laura Pyle, PhD
SUB_INVESTIGATOR
Sarit Polsky, MD
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 3 months during randomization to intervention or standard care
time spent with glucose 70-180mg/dL on continuous glucose monitor
Time frame: 3 months during randomization to intervention or standard care
standard deviation (mg/dL) of glucose on continuous glucose monitor
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
standard deviation (mg/dL) of glucose on continuous glucose monitor
Time frame: 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
Contact information is provided by the study sponsor or research team.
Catherine Chartier-Logan, MPH
CONTACT
JANET K SNELL-BERGEON, PhD, MPH
CONTACT
University of Colorado, Denver
Other
Acronym: MERIT
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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