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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT06297980
Status
Recruiting
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Conditions

  • Hyperglycaemia Due to Type 1 Diabetes Mellitus
  • Hypoglycemia
  • Menstruation Disturbances
  • Type 1 Diabetes

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • Personalized modifications to treatment to address menstrual cycle effects on glycemia — OTHER
    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.

Study Details

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.

Key Dates

Start date
Mar 15, 2024
Status verified
Feb 2024
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • No Intervention: Standard Care
    In this arm, women will continue with their usual insulin dose, food intake and glycemic algorithms as determined by their provider

Primary Outcome Measure

Glucose time in range [ Time Frame: 3 months during randomization to intervention or standard care ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of ColoradoAuroraColorado80045
JANET K SNELL-BERGEON, PhD
[email protected]
303-724-6762
Catherine Chartier-Logan, MPH
[email protected]
3037247505
Sarit Polsky, MD (SUB_INVESTIGATOR)
Cristy Geno, PhD (SUB_INVESTIGATOR)
Bryan Bergman, PhD (SUB_INVESTIGATOR)
Laura Pyle, PhD (SUB_INVESTIGATOR)

Find similar trials in Aurora, CO

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
University of Colorado· Aurora, CO

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