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

NCT06297980 | Recruiting

• 1 other identifier: 23-1513
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Glucose time in range

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

  3 months during randomization to intervention or standard care

• Glucose standard deviation

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

  3 months during randomization to intervention or standard care

Secondary Outcomes (5)

• Mean glucose (mg/dL) pre-exercise

  mean glucosewithin 5 minutes of beginning planned exercise bouts based on start time reported by study participant and/or accelerometer data

• Mean glucose (mg/dL) while exercising

  mean glucose measured every 5 minutes while actively exercising (between exercise start and end times as reported by study participant or based on accelerometer data, from a minimum of 5 minutes to up to 480 minutes)

• Mean glucose (mg/dL) over 24 hours after exercise

  mean glucose during the 24 hours after beginning planned exercise bouts (from participant reported or acceleromater data based start of exercise to 24 hours later)

• Glucose standard deviation

  glucose standard deviation during the follicular (starting day one of the menstrual period as self-reported by study participant through a positive home test for ovulation by participant, or for a maximum of 30 days if no positive ovulation test)

• Glucose standard deviation

  glucose standard deviation during the luteal menstrual cycle phase (starting from the day of a positive home ovulation test to the start of the next period reported by participant, for a maximum of 30 days if no next period begins)

Study Arms (2)

Personalized treatment

EXPERIMENTAL

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.

Other: Personalized modifications to treatment to address menstrual cycle effects on glycemia

Standard Care

NO INTERVENTION

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 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.

Personalized treatment

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women 18-45 who have had type 1 diabetes for at least 12 months
• Premenopausal with either menstrual cycles or currently using oral contraceptives

You may not qualify if:

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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• The Leona M. and Harry B. Helmsley Charitable Trust: collaborator

Study Sites (1)

University of Colorado

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hypoglycemia; Menstruation Disturbances; Motor Activity; Hyperglycemia

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• JANET K SNELL-BERGEON, PhD, MPH

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

JANET K SNELL-BERGEON, PhD, MPH

CONTACT

3037246762; Janet.Snell-Bergeon@cuanschutz.edu

Catherine Chartier-Logan, MPH

CONTACT

3037247505; Catherine.Chartier-Logan@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This will be a parallel group randomized control trial of a personalized glucose control intervention to target changes in glycemic control related to the menstrual cycle that are identified during a 3 month observational period.

Study Record Dates

• First Submitted: February 12, 2024
• First Posted: March 7, 2024
• Study Start: March 15, 2024
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: March 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Data will become available within 12 months from the end of the data collection
• Access Criteria: Researchers wishing to access IPD will be requested to complete an application and a data transfer agreement

Locations

US (1)