RecruitingNCT06959316

T1D Pregnancy & Me

Pregnancy Data Repository to Assess Management of Type 1 Diabetes With Diabetes Technology

Sponsor

Jaeb Center for Health Research

Enrollment

500 participants

Start Date

Apr 25, 2025

Study Type

OBSERVATIONAL

Conditions

Diabetes Mellitus, Type 1 Pregnancy in Diabetics

Summary

T1D Pregnancy \& Me will partner with pregnant participants living with type 1 diabetes (T1D) in the United States to collect real-world data on management of T1D in pregnancy. This is a remote study where participants can complete online surveys and share device data (continuous glucose monitor (CGM) data and insulin data). Through the collection of CGM, insulin, and pregnancy outcome data, the study will provide important information to understand how diabetes is being managed during pregnancy. These data will provide much needed evidence to guide modern management of diabetes during pregnancy with a goal of improving care and outcomes.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is collecting data from pregnant women with type 1 diabetes to better understand glucose management during pregnancy and identify the best blood sugar targets. Researchers will use continuous glucose monitoring (CGM) data, health records, and surveys to improve care for both mother and baby. **You may be eligible if...** - You are 18 or older - You have had type 1 diabetes for at least 6 months - You are less than 15 weeks pregnant at the time of enrollment - You are currently using or plan to use a continuous glucose monitor (CGM) regularly (at least 10 out of every 14 days) **You may NOT be eligible if...** - You have type 2 diabetes or gestational diabetes (not type 1) - You are 15 weeks or more pregnant at enrollment - You do not use or are unwilling to use a CGM device regularly - You have other serious health conditions that would complicate data interpretation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEHybrid closed loop insulin delivery system

Hybrid closed loop insulin delivery system is a system that uses a continuous glucose monitor (CGM) to send blood glucose values to an insulin pump that automatically provides insulin based on the blood glucose value and anticipated future level.