NCT04665999

Glycemic Profiles And Insulin Delivery Across The Menstrual Cycle In Women With Type 1 Diabetes

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 37 (actual)
• Sponsor: University of Virginia · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

This is an observational study. Forty females with type 1 diabetes (age 18-40) using a continuous glucose monitor and an insulin pump will be enrolled for a 3-month data collection. Study participants will include free-cycling females and females following oral contraceptive therapy. All study appointments may be completed virtually.

Detailed description

Females, age 18-40 y.o., diagnosed with type 1 diabetes and currently using an insulin pump, will be provided a study continuous glucose monitor (CGM) in order to collect 3 full menstrual cycle data within 180 days. Enrollment may last from 3-5 months. Study participants will include free-cycling females and females following oral contraceptive therapy. Study CGMs and activity trackers will be provided for the entire data collection period. During data collection, all participants will be asked to record meals consumed and free-cycling females will be asked to confirm ovulation by means of study-provided ovulation kits. The Clue app will be recommended to study participants to record dates of beginning of menses and ovulation (if applicable).

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	Continuous Glucose Monitor	Data collection only

Timeline

• Start date: 2021-01-15
• Primary completion: 2022-03-10
• Completion: 2022-03-10
• First posted: 2020-12-14
• Last updated: 2022-04-06

Locations

1 site across 1 country: United States