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

NCT06297980 · University of Colorado, Denver
In plain English

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About this study
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
Study design
Enrollment target: 150 participants
Allocation: randomized
Masking: none
Age groups: adult
Timeline
Starts: 2024-03-15
Estimated completion: 2026-10-31
Last updated: 2024-03-07
Interventions
Other: Personalized modifications to treatment to address menstrual cycle effects on glycemia
Primary outcomes
  • Glucose time in range (3 months during randomization to intervention or standard care)
  • Glucose standard deviation (3 months during randomization to intervention or standard care)
Sponsor
University of Colorado, Denver · other
With: The Leona M. and Harry B. Helmsley Charitable Trust
Contacts & investigators
ContactJANET K SNELL-BERGEON, PhD, MPH · contact · Janet.Snell-Bergeon@cuanschutz.edu · 3037246762
ContactCatherine Chartier-Logan, MPH · contact · Catherine.Chartier-Logan@cuanschutz.edu · 3037247505
InvestigatorJANET K SNELL-BERGEON, PhD, MPH · principal_investigator, University of Colorado, Denver
All locations (1)
University of ColoradoRecruiting
Aurora, Colorado, United States