NCT06297980

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-03-15
• Primary completion: 2026-10-31
• Completion: 2026-10-31
• First posted: 2024-03-07
• Last updated: 2024-03-07

Locations

1 site across 1 country: United States