Impact of MEnstruation on Glycemic Response and Exercise In Females With Type 1 Diabetes
NCT ID: NCT06297980
Last Updated: 2024-03-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
150 participants
INTERVENTIONAL
2024-03-15
2026-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
Standard Care
In this arm, women will continue with their usual insulin dose, food intake and glycemic algorithms as determined by their provider
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Premenopausal with either menstrual cycles or currently using oral contraceptives
Exclusion Criteria
18 Years
45 Years
FEMALE
No
Sponsors
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The Leona M. and Harry B. Helmsley Charitable Trust
OTHER
University of Colorado, Denver
OTHER
Responsible Party
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Principal Investigators
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JANET K SNELL-BERGEON, PhD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Locations
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University of Colorado
Aurora, Colorado, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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23-1513
Identifier Type: -
Identifier Source: org_study_id
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