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

University of Colorado Denver (CU Denver)

Status: Enrolling

Conditions: Hypoglycemia; Menstruation Disturbances; Type 1 Diabetes; Hyperglycaemia Due to Type 1 Diabetes Mellitus

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06297980

23-1513

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Personalized treatment

Experimental group

Description:

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.

Treatment:

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

Standard Care

No Intervention group

Description:

In this arm, women will continue with their usual insulin dose, food intake and glycemic algorithms as determined by their provider