Impact of Menstruation on Glycemic Response and Exercise in Females With Type 1 Diabetes

This study is looking at how your menstrual cycle and hormonal birth control might affect your blood sugar (glycemic control) if you have Type 1 Diabetes. Researchers will observe your glucose patterns using continuous glucose monitoring (CGM) for three months to see how your blood sugar changes during different phases of your cycle and with exercise. Then, they will test personalized adjustments to your insulin doses (basal or bolus rates) and carbohydrate ratios to help manage these changes. The goal is to improve your blood sugar control throughout your menstrual cycle. We are looking for women aged 18 to 45 who have had Type 1 Diabetes for at least 12 months and have regular menstrual cycles or use oral contraceptives. Success will be measured by how much time your blood sugar stays within a healthy range and how stable your blood sugar levels are after three months of the intervention. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 150 women. It involves an observational period followed by personalized adjustments to treatment.
What's involved
You would participate in a three-month observational period where your glucose patterns are monitored. This is followed by personalized changes to your insulin and food intake.
Compensation
Not stated in the trial record.
Follow-up
Glucose time in range and standard deviation will be measured at 3 months during randomization to intervention or standard care.

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NCT06297980

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

Recruiting
NAAges 18–45InterventionalTreatment
University of Colorado, Denver
~150 participants
Updated 2026-06-16 on ClinicalTrials.gov
What's tested:Personalized modifications to treatment to address menstrual cycle effects on glycemia

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Glucose time in range
Measured over 3 months during randomization to intervention or standard care
+1 more outcome measured
Type 1 Diabetes
Hypoglycemia
Hyperglycaemia Due to Type 1 Diabetes Mellitus
Menstruation Disturbances
1 sites across 1 states
Colorado1
  • JANET K SNELL-BERGEON, PhD, MPH · PRINCIPAL_INVESTIGATOR · University of Colorado, Denver

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Eligibility criteria

Inclusion

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

Women who are postmenopausal, pregnant, trying to become pregnant, or have had a hysterectomy
  • Glucose time in range3 months during randomization to intervention or standard care

    time spent with glucose 70-180mg/dL on continuous glucose monitor

  • Glucose standard deviation3 months during randomization to intervention or standard care

    standard deviation (mg/dL) of glucose on continuous glucose monitor