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

NCT06297980 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2024-03-07

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • The Leona M. and Harry B. Helmsley Charitable Trust

    collaborator OTHER

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • JANET K SNELL-BERGEON, PhD, MPH · University of Colorado, Denver

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-15
Primary Completion
2026-10-31
Completion
2026-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06297980 on ClinicalTrials.gov