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

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.

Study Overview

• Status: Recruiting
• Conditions: Hypoglycemia; Menstruation Disturbances; Type 1 Diabetes; Hyperglycaemia Due to Type 1 Diabetes Mellitus
• Intervention / Treatment: Other: Personalized modifications to treatment to address menstrual cycle effects on glycemia

Detailed Description

The overall goal of this project is to further understand the impact of hormonal status on glycemic metrics and to test personalized changes to insulin dosing, through implementing the following specific aims:

Specific Aim 1: Using CGM, examine glucose levels among women with T1D by menstrual cycle phase over a three month period to establish baseline glycemic variability, to identify personalized patterns of glycemic control across the menstrual cycle phase, and to test glycemic responses to acute bouts of aerobic, interval and resistance training.

Specific Aim 2: Using the data from the observational period, examine patterns of glycemic variability by menstrual cycle phase in order to determine the appropriate alteration to insulin delivery needed to improve glycemic control across the menstrual cycle among women with T1D

Specific Aim 3: Test an intervention that includes up to four personalized adjustments to food intake, insulin dose and glycemic algorithms by menstrual cycle phase in a randomized intervention and control group. We will also examine responses to daily activity, planned exercise activities, and acute bouts of aerobic, interval and resistance exercise.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Catherine Chartier-Logan, MPH; Phone Number: 3037247505; Email: Catherine.Chartier-Logan@cuanschutz.edu
• Study Contact Backup: Name: JANET K SNELL-BERGEON, PhD, MPH; Phone Number: 3037246762; Email: Janet.Snell-Bergeon@cuanschutz.edu

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado
      • Sub-Investigator: Laura Pyle, PhD
      • Contact: Catherine Chartier-Logan, MPH; Phone Number: 3037247505; Email: Catherine.Chartier-Logan@cuanschutz.edu
      • Contact: JANET K SNELL-BERGEON, PhD; Phone Number: 303-724-6762; Email: Janet.Snell-Bergeon@cuanschutz.edu
      • Sub-Investigator: Sarit Polsky, MD
      • Sub-Investigator: Cristy Geno, PhD
      • Sub-Investigator: Bryan Bergman, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean glucose (mg/dL) pre-exercise	Mean glucose from continuous glucose monitor in response to 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 from continuous glucose monitor in response to exercise	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 from continuous glucose monitor in response to 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	standard deviation (mg/dL) of glucose on continuous glucose monitor	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	standard deviation (mg/dL) of glucose on continuous glucose monitor	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)

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: The Leona M. and Harry B. Helmsley Charitable Trust
• Investigators: Principal Investigator: JANET K SNELL-BERGEON, PhD, MPH, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Estimated): March 15, 2024
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026

Study Registration Dates

• First Submitted: February 12, 2024
• First Submitted That Met QC Criteria: February 29, 2024
• First Posted (Actual): March 7, 2024

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: menstrual cycle; exercise; hypoglycemia; glucose control; type 1 diabetes; hyperglycemia
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Hyperglycemia; Diabetes Mellitus; Menstruation Disturbances; Diabetes Mellitus, Type 1; Hypoglycemia
• Other Study ID Numbers: 23-1513

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: There will be a steering committee that will review requests for individual participant data through an ancillary study and paper proposal process
• IPD Sharing Time Frame: Data will become available within 12 months from the end of the data collection
• IPD Sharing Access Criteria: Researchers wishing to access IPD will be requested to complete an application and a data transfer agreement
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No