Recruiting

Observational Study

Sponsor:

University of Colorado, Denver

Code:

NCT06297980

Conditions

Type 1 Diabetes

Hypoglycemia

Hyperglycaemia Due to Type 1 Diabetes Mellitus

Menstruation Disturbances

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Interventions

Personalized modifications to treatment to address menstrual cycle effects on glycemia

Study Details

Brief 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

Type 1 Diabetes

Hypoglycemia

Hyperglycaemia Due to Type 1 Diabetes Mellitus

Menstruation Disturbances

Study ID

NCT06297980

Start date

Mar 24, 2024

Status verified date

Jun, 2026

Completion date

Oct 31, 2027

Anticipated

Primary completion date

Oct 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • Women who are postmenopausal, pregnant, trying to become pregnant, or have had a hysterectomy

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

JANET K SNELL-BERGEON, PhD, MPH

3037246762Janet.Snell-Bergeon@cuanschutz.edu

Catherine Chartier-Logan, MPH

3037247505Catherine.Chartier-Logan@cuanschutz.edu

Locations

University of Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

JANET K SNELL-BERGEON, PhD

3037246762Janet.Snell-Bergeon@cuanschutz.edu

Catherine Chartier-Logan, MPH

3037247505Catherine.Chartier-Logan@cuanschutz.edu

More Information

Sponsor

University of Colorado, Denver

Last update posted

Jun 16, 2026

Last verified

Jun, 2026

Keywords

  • type 1 diabetes
  • menstrual cycle
  • exercise
  • hypoglycemia
  • hyperglycemia
  • glucose control

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2026-06-16.