Actively Recruiting
Impact of Menstruation on Glycemic Response and Exercise in Females With Type 1 Diabetes
Led by University of Colorado, Denver · Updated on 2024-03-07
150
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Colorado, Denver
Lead Sponsor
T
The Leona M. and Harry B. Helmsley Charitable Trust
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying how sex hormones, including the use of hormonal birth control and menstrual cycle phases, affect blood sugar control in women with type 1 diabetes (T1D). The study aims to understand the patterns of blood sugar changes throughout the menstrual cycle and how these impact responses to physical activity. It also tests personalized adjustments to insulin doses and food intake to reduce cycle-related blood sugar fluctuations. Participants will undergo a three-month observation period using continuous glucose monitoring to track blood sugar patterns by menstrual cycle phase and responses to different types of exercise like aerobic, interval, and resistance training. After this, women will be randomly assigned to either a group receiving personalized adjustments to insulin and diet based on their cycle or a control group continuing their usual care. The intervention includes up to four tailored changes to insulin dosing, food intake, and glycemic algorithms. During the study, participants will regularly report menstrual cycle details and exercise activities while wearing glucose monitors. Researchers will assess blood sugar control, variability, and responses to exercise over the course of the trial. The main outcomes focus on glucose time in range and glucose variability measured over three months during the randomized intervention or control period. Patient-reported outcomes and safety are also monitored. The study is sponsored by the University of Colorado, Denver and runs until October 2026.
CONDITIONS
Brief Title
Impact of MEnstruation on Glycemic Response and Exercise In Females With Type 1 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 to 45 years
- Diagnosis of type 1 diabetes for at least 12 months
- Premenopausal with menstrual cycles or currently using oral contraceptives
You will not qualify if you...
- Postmenopausal women
- Women who are pregnant or trying to become pregnant
- Women who have had a hysterectomy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 3 months
Participants wear continuous glucose monitors to observe glucose levels and menstrual cycle phases over a three month period to establish baseline glycemic variability and patterns.
Regular monitoring with continuous glucose monitoring devices
Duration - 3 months
Participants receive personalized adjustments to insulin dosing, food intake, and glycemic algorithms based on their menstrual cycle phase to improve glycemic control, or continue standard care depending on randomization.
Visits scheduled according to intervention protocol; frequency varies by participant assignment
Trial Site Locations
Total: 1 location
1
University of Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
J
JANET K SNELL-BERGEON, PhD, MPH
C
Catherine Chartier-Logan, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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